November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The Claria MRI CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

"Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven't been able to determine if that stimulation actually improves the heart's pumping ability," said Suneet Mittal, M.D., director, electrophysiology laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, N.J. "With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT."

A large percentage of heart failure patients receiving cardiac resynchronization therapy have atrial fibrillation (AF),1 which can significantly reduce patient response to CRT. The Claria device includes the Medtronic-exclusive EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during AF, without adversely affecting the average heart rate.

Additional features on the Claria device include:

• The AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59 percent,2 and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing;3
• VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,4 and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient;
• Attain Perfoma MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence,5 steroid on all electrodes, and three shapes for varying patient anatomies; and
• SureScan MR-conditional labeling for full-body scans without positioning restrictions. Medtronic now offers MR-conditional pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs) and CRT-Ds. Additionally, patients with certain existing defibrillation leads will be eligible for an MR-conditional ICD or CRT-D, and thus able to access this important imaging technology.

Medtronic also has submitted a Pre-Market Application (PMA) to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds.

For more information: www.medtronic.com

References

1 Kloosterman M, Maass AH, Rienstra M, Van Gelder IC. Atrial fibrillation during cardiac resynchronization therapy. Card Electrophysiol Clin. December 2015;7(4):735-748.
2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
3 Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
4 Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
5 Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study. Circulation Arrhythmia and Electrophysiology. 2012.

August 29, 2016 — Investment research firm Muddy Waters Capital released a report Aug. 25 saying it believes St. Jude Medical (SJM) will lose up to half of its revenue due to what it calls issues with its electrophysiology (EP) devices, including pacemakers, implantable cardioverter defibrillators (IDCs) and cardiac resynchonization therapy (CRT) devices. The research firm said these SJM devices, making up nearly 46 percent of SJM’s revenue, pose a public health risk and might be recalled or need remediation, including the cyber attack vulnerability of the device technology. SJM responded Aug. 29, calling the report false and misleading. 

“SJM’s pacemakers, ICDs and CRTs might – and in our view, should – be recalled and remediated,” the Muddy Waters report stated. “Even lacking a recall, the product safety issues we present in this report offer unnecessary health risks and should receive serious notice among hospitals, physicians and cardiac patients. We have seen demonstrations of two types of cyber attacks against STJ implantable cardiac devices.”

The firm reported a “crash” attack that causes cardiac devices to malfunction – including by apparently pacing at a potentially dangerous rate. It claimed a second reported incident was a battery drain attack that could be particularly harmful to device-dependent users. The report claims SJM cardiac devices can be attacked within a roughly 50 foot radius. It also theorizes that attacks can be executed on a large scale against patients using the thousands of remote Merlin home monitoring devices STJ has distributed. 

Read SJM’s response to the report in the article “St. Jude Brings Legal Action Against Market Research Firm for Report Bashing its EP Device Cybersecurity.”

“We have examined the allegations made by Capital and MedSec on Aug. 25, regarding the safety and security of our pacemakers and defibrillators, and while we would have preferred the opportunity to review a detailed account of the information, based on available information, we conclude that the report is false and misleading,” SJM said in its Aug. 29 statement. “Our top priority is to reassure our patients, caregivers and physicians that our devices are secure and to ensure ongoing access to the proven clinical benefits of remote monitoring. St. Jude Medical stands behind the security and safety of our devices as confirmed by independent third parties and supported through our regulatory submissions.”

SJM said remote monitoring is a safe and effective means for patients to communicate with their physician and has been well documented in leading publications that remote monitoring saves lives. Similar remote monitoring technologies also are offered by SJM’s competitors Biotronik, Boston Scientific, Medtronic and the Sorin Group. The company said it works with third-party experts, researchers, government agencies and regulators in cybersecurity to develop appropriate safeguards for its data and devices as part of its product development process and life cycle. These experts assist in designing security controls from the early stages of product design through final release and ongoing product enhancements, including software updates and security patches for products. SJM also said it conducts regular risk assessments based on U.S. Food and Drug Administration (FDA) guidance and perform penetration tests using internal and external experts. 

“Our system provides an automated remote upgrade process for all Merlin@home units that are in active use so that security enhancements are automatically deployed when they become available,” SJM said. “Merlin@home units that are not in active use and connected to the internet will also be upgraded when they return to use if a new update is available. Our analysis concluded that the majority of the observations in the report apply to older versions of the Merlin@home devices (i.e., those that have not been updated through the automated remote upgrade process). We are confident in the technology that we provide and in our process for continuously building upon our security protocols and processes.”

Claims of Remote Battery Depletion are Misleading

The Muddy Waters report claimed that the battery could be depleted at a 50-foot range. SJM said this is not possible since once the device is implanted into a patient, wireless communication has an approximate 7-foot range. “This brings into question the entire testing methodology that has been used as the basis for the Muddy Waters Capital and MedSec report,” SJM said. The company said the report described a scenario where it would require hundreds of hours of continuous and sustained “pings” within this distance, meaning a patient would need to remain immobile for days on end and the hacker would need to be within 7 feet of the patient, SJM said. In the unlikely instance that was to occur, SJM said its implanted devices are designed to provide a vibratory patient alert if the battery dips below a certain threshold to protect and notify patients.

Safeguards in Place to Mitigate Crash Attacks

SJM said its devices are designed to go into a life-sustaining “safe” mode, as a safeguard, if unexpected conditions are detected. These safeguards will put the device into safe mode where the preprogrammed pacing and defibrillation functions of the implantable medical devices revert to safe settings. In addition, some SJM devices are designed to disable further RF communications for a period of time, which may appear to the untrained eye as having rendered the device disabled, although it continues to function.

SJM explained its devices also have built-in measures to reduce the risk of unauthorized commands being issued to our implantable devices. In addition, the company has an ongoing focus to continually strengthen its security systems in the ever changing cybersecurity environment. For example:

• Access controls help protect the Merlin@home™ operating system from unauthorized access
• The lack of built-in programming commands in Merlin@home help ensure that therapy is provided through the implanted device only at the direction of the physician
• Proprietary implantable medical device protocols protect communications with the implantable device
• Encryption of session authentication between the implantable medical device and Merlin@home further enhances device security
• The limited Medical Implant Communication Services (MICS) wireless range restricts accessibility of communications with the implantable device

Flawed Test Methodology on Updated Software

The report claimed that the system could be impaired, similar to when a computer system “crashes.” SJM points out the report has little detail on this simulation and includes many inconsistencies. The company said a screenshot in the report of the Merlin programmer shows a device that is functioning normally. The red items on the screen are highlighting the fact that there are no leads connected to the device. The device is pacing properly, at the programmed 40 bpm. The screenshot shows expected behavior from the SecureSense algorithm when device is pacing without any connected leads, SJM said.

SJM Says it is Vigilant

SJM reiterated its software has been evaluated by several independent organizations and researchers, including Deloitte and Optiv. In addition, Merlin.net was Safe Harbor certified by St. Jude Internal Audit in 2013 and annually since then. This includes an annual audit of key security controls within the Merlin.net environment and Merlin.net has received ISO 27001 certification since 2009. The company said this includes an internal audit of security controls and an independent certification by a third party, BSI. In 2015, it successfully completed an upgrade to the ISO 27001:2013 certification.

“Muddy Waters also makes numerous unsubstantiated statements that are speculative with no evidence shown to prove the claims such as an ability to impersonate any SJM device, reverse engineering to create a pocket-size programmer, and a large-scale attack through the Merlin network,” SJM stated. “However, we are not aware of such threats and will remain vigilant to the ever-increasing sophistication of those seeking access to devices/data and address any issues based on additional detail provided.”

The vendor said the report is unnecessarily alarming patients.

The Muddy Waters report can be found at www.muddywatersresearch.com/research/stj/mw-is-short-stj/

For more information on SJM: sjm.com

August 30, 2016 — Medtronic plc announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study at the 2016 European Society of Cardiology (ESC) Congress in Rome. The study showed that the Medtronic-exclusive device-based EffectivCRT during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF).

Current CRT devices report "percent pacing"— a measure of whether the device sends a pacing pulse to stimulate the heart. However, current devices do not report the effectiveness of each pacing stimulus — that is, whether the pacing pulse "captures" the heart muscle and improves its pumping ability.

The new EffectivCRT during AF feature automatically determines the effectiveness of each left ventricular pace and adjusts pacing rates during AF. This is important for heart failure patients suffering from AF, because the pacing pulse from the device is more likely to be ineffective or interrupted because of this irregular heart rhythm.

"This technology brings us one step closer to understanding effective left ventricular pacing for AF patients receiving CRT, which has been difficult to manage in the past" said Suneet Mittal, M.D., director, electrophysiology laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, N.J. "We can now optimize treatment to a larger patient base, including difficult-to-treat non-responders, to hopefully prevent patients from undergoing additional treatments and often invasive follow-on procedures."

The EffectivCRT Diagnostic and EffectivCRT during AF algorithm are available on the Claria MRI Quad CRT-D SureScan in Europe.

The EffectivCRT features are investigational only in the United States; the Claria CRT-D is not approved for sale in the U.S.

The Claria device, which is approved for full-body magnetic resonance imaging (MRI) scans in 1.5 and 3T machines, can be paired with Attain Performa quadripolar lead technology. In addition to the new EffectivCRT features, the Claria device includes the Medtronic-exclusive AdaptivCRT algorithm, which has been shown to provide a 46 percent reduction in AF risk1 and reduce a patient's odds of a 30-day heart failure readmission by 59 percent2.

CRTee was a prospective, randomized, crossover study of 71 patients with paroxysmal, persistent or permanent AF. Sixty-six patients were randomized first to either an existing algorithm or the new EffectivCRT algorithm, with the desired outcome of a higher percent of effective CRT being delivered during AF. Fifty-four patients completed both arms. The EffectivCRT group increased effective pacing during AF by 7 percent, from 81 percent to 88 percent, p<0.001. Heart rate increased by only three beats-per-minute, from 77 to 80 BPM, p<0.001. Patients with a low percent of pacing at baseline (less than or equal to 80 percent) received the greatest benefit (average absolute increase of 15 percent effective pacing).

For more information: www.medtronic.com

1 Martin DO, et al. Clinical Outcomes with Adaptive Cardiac Resynchronization Therapy: Long-Term Outcomes of the Adaptive CRT Trial. HFSA Late Breakers. September 23, 2013.
2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.

September 7, 2016 — St. Jude Medical Inc. (SJM) has filed a lawsuit against Muddy Waters Consulting LLC, Muddy Waters Capital LLC, MedSec Holdings Ltd., MedSec LLC and three individual defendants who are principals in these firms, for false statements, false advertising, conspiracy and the related manipulation of the public markets. This is in regards to a market report these firms released in August that claimed SJM’s implantable electrophysiology (EP) cardiac rhythm management devices were not secure against cyber attack and present a danger to patient safety. With this court action, SJM said it seeks to hold these firms and individuals accountable for what the company calls false and misleading tactics. The company also said it wants to set the record straight about the security of its devices and to help cardiac patients and their doctors make informed medical decisions.

The investment research firm Muddy Waters Capital released a report Aug. 25 saying it believed SJM would lose up to half of its revenue due to what it calls issues with its EP devices, including pacemakers, implantable cardioverter defibrillators (IDCs) and cardiac resynchonization therapy (CRT) devices. The firm claimed these devices pose a public health risk and might be recalled or need remediation because of their vulnerability to cyber attack. SJM responded Aug. 29, calling the report false and misleading. 

Read the article “Market Report Calls Into Question St. Jude Medical EP Device Safety, Cybersecurity.”

"We felt this lawsuit was the best course of action to make sure those looking to profit by trying to frighten patients and caregivers and by circumventing appropriate and established channels for raising cybersecurity concerns, do not use this avenue to do so again,” said Michael T. Rousseau, president and chief executive officer at St. Jude Medical. He said SJM has processes in place to encourage anyone with information about the security of our technology to share it with the company so it can be resolved. ”We believe this lawsuit is critical to the entire medical device ecosystem — from our patients who have our life saving devices, to the physicians and caregivers who care for them, to the responsible security researchers who help improve security, to the long-term St. Jude Medical investors who incurred losses due to false accusations as part of a wrongful profit-making scheme."

The lawsuit filed Sept. 7 alleges that Muddy Waters, MedSec and the other defendants intentionally disseminated false and misleading information in order to lower the value of SJM stock and to wrongfully profit from a drop in share value through a short-selling scheme. The company’s complaint claims the defendants’ served their own financial self-interest by attempting to mislead doctors and patients and demonstrates a total disregard for the patients whose lives depend on their cardiac management devices. The complaint also cites a third-party assessment of the Muddy Waters Report by University of Michigan researchers who found that “the evidence does not support their conclusions… [the University of Michigan researchers] were able to generate the reported conditions without there being a security issue.” In addition, an electrophysiologist and cardiologist from the University of Michigan also stated that “given the significant benefits from home monitoring, patients should continue to use their prescribed cardiac devices” at this time.

“We recognize that the cybersecurity landscape is dynamic, which is why we partner with researchers, agencies, consultants and others to continually strengthen our security measures currently in place,” said Phil Ebeling, SJM vice president and chief technology officer. “We also have processes in place to encourage anyone with information about the security of our technology to share it with us so that we can enhance our technology for the benefit of patients.”

SJM said its devices and systems have multiple features to reduce the risk of cyber security attacks and works with the U.S. Food and Drug Administration, the Department of Homeland Security and independent researchers to continually strengthen its security systems.

"Our top priority is to reassure patients, caregivers and physicians who use our life-saving devices that we are committed to the security of our products and to ensure patients and their doctors maintain ongoing access to the proven clinical benefits of remote monitoring," said Mark Carlson, SJM ice president and chief medical officer. "We decided to take this action because of the irresponsible manner in which these groups have acted."

The lawsuit was filed in the United States District Court for the District of Minnesota. This case follows St. Jude Medical's recent statements that refuted claims by Muddy Waters and MedSec regarding the safety and security of our pacemakers and defibrillators.

For more information: sjm.com 

September 15, 2016 — EBR Systems Inc. announced the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) for its WiSE (Wireless Stimulation Endocardially) Technology for cardiac resynchronization therapy (CRT). This IDE enables EBR Systems to start a major U.S. study to establish safety and effectiveness in support of U.S. approval.

“WiSE is unique, significant technology that’s cleared for use in Europe and has proven very beneficial thus far,” said Jagmeet Singh, M.D., DPhil, principal investigator for the planned study, and associate chief of cardiology and professor of medicine at Harvard Medical School at Massachusetts General Hospital. “This important medical advance addresses major shortcomings in current CRT implants and could dramatically improve success rates for heart failure patients around the globe.”

EBR Systems’ WiSE Technology is the world’s only wireless, endocardial (inside the heart) pacing system for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is recognized as a potentially superior, more anatomically correct pacing location.

Studies have demonstrated that successful CRT therapy reduces heart failure symptoms, hospitalizations and mortality by synchronizing the left and right ventricles. However, approximately 30 percent of patients receiving conventional CRT do not respond to the therapy. A major cause of this shortcoming is believed to be the inconsistency of results achieved using wire leads to transmit pacing pulses to the left ventricle’s epicardial (exterior) surface.

Although it is generally accepted that internal stimulation of the left ventricle is preferable, wire leads or large implants placed inside the left ventricle can cause clots, heart attacks or stroke. Consequently, this pacing location is not currently used by commercially-available CRT systems in the United States.

Additionally, wire leads can break or otherwise fail, leading to complications in roughly 12 percent of cases.

The financial impact of these issues is profound. More than $1 billion of $3.5 billion spent annually on CRT devices provides no patient benefit. Research indicates EBR Systems’ WiSE Technology could potentially benefit 1.5 million patients worldwide.

WiSE Technology addresses those problems by enabling cardiac pacing with a novel, cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle — and the attendant problems — are eliminated.

“Patients who have failed conventional CRT continue to deteriorate from their heart failure and are repeatedly subjected to costly hospitalizations,” said Ohio State University Professor of Medicine William Abraham, M.D., heart failure expert, director of OSU’s Wexner Medical Center and member of the study’s steering committee. “We have actively sought new treatment alternatives for this large and growing patient population.

“WiSE is easily the most promising solution to this costly problem. Its tiny receiver makes endocardial, left ventricular pacing possible for the first time. There is nothing like it in cardiology.”

IDE approval gives EBR Systems clearance to initiate the 350 patient Stimulation Of the Left Ventricle Endocardially–CRT study (SOLVE-CRT). These patients must have either failed conventional CRT or they were previously untreatable with conventional CRT systems

The SOLVE-CRT study will be a prospective, randomized controlled trial using generally-accepted measures of safety and efficacy as primary endpoints at six months. EBR Systems anticipates starting this clinical trial in mid-2017.

EBR anticipates introducing its second-generation WiSE Technology in Europe in early 2017 and subsequently including it in the SOLVE-CRT study. The transmitter size has been reduced by half, making it smaller than a conventional pacemaker. Second generation battery life is expected to equal conventional CRT systems.

Results of EBR Systems’ prior SELECT-LV study were presented in May 2016 by Mt. Sinai Hospital cardiologist and Professor of Medicine Vivek Reddy, M.D., at the Heart Rhythm Society Scientific Sessions in San Francisco. In a study of 35 patients who had failed conventional CRT therapy, 97 percent were implanted successfully with WiSE Technology. Of the thirty-three patients who reached the six-month effectiveness endpoint, 85 percent improved their clinical composite score which is a measure of symptom improvement.

EBR Systems’ WiSE Technology consists of a tiny electrode implanted in the left ventricle. With every heartbeat, it receives a synchronized ultrasound signal from a small transmitter placed between two ribs. Those sound waves are converted to electrical energy, providing cardiac pacing.

This unique technology eliminates the need for a left ventricular lead and lets the physician place the stimulation point at a more ideal location inside the left ventricle (endocardially) where it can be most effective. Endocardial stimulation is generally considered more like the natural activation pattern of the heart than today’s epicardial (surface) pacing techniques. Data from multiple sources strongly suggests this can benefit patients and is a potential major advance in left ventricular stimulation.

For more information: www.ebrsystemsinc.com

September 20, 2016 — Medtronic plc announced the results of an analysis that reveals patients increasingly adhere to heart failure medications after they receive cardiac resynchronization therapy (CRT) devices. The analysis of more than 4,500 patients revealed that compliance with their medications increased 67 percent 24 months after receiving their CRT implants, compared to the 24 months prior to implant (p<0.001). The results were presented at the 2016 Heart Failure Society of America (HFSA) Scientific Meeting in Orlando, Fla.

CRT is a proven treatment for select patients with heart failure, and in combination with optimal medical therapy has been shown to further reduce patients’ symptoms and extend their survival. Patients’ adherence to medication is a major component of heart failure self-management, and commonly prescribed therapies include angiotensin-converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers (BB), direct renin inhibitors (DRI), and diuretics for patients with heart failure and a reduced ejection fraction. Additionally, for heart failure patients whose hearts pump out of sync, professional medical guidelines recommend cardiac resynchronization therapy-pacemakers (CRT-P) or -defibrillators (CRT-D).

The retrospective analysis used administrative claims data from 4,512 patients, younger than 65 years old, who received CRT devices between January 2008 and December 2014. Patients’ adherence to a regimen of guideline-recommended medication classes (diuretic, ACE-I, ARB, BB, aldosterone antagonist, digoxin, and statin) before CRT and after CRT implantation was assessed using proportion of days covered (PDC), which measures the availability of all prescribed medications simultaneously in these patients’ homes.

The number of patients considered fully compliant with their medication regimens (PDC ≥ 80 percent) nearly doubled at 12 months following CRT implants. Additionally, the proportion of compliant patients increased substantially for individual medication classes at 12 months following CRT implants (ACE-I at 54.4 percent vs 37.1 percent, BB at 58.2 percent vs 33.9 percent, loop diuretic at 41.8 percent vs 27 percent).

“With some heart failure patients, CRT is a turning point in their treatment plan because — in addition to their being monitored more closely — the severity of their symptoms diminish. Technology may lead to greater medication compliance, helping heart failure patients better manage their conditions, while keeping them out of the hospital and, ultimately, reducing costs for the healthcare system,” said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, and medical director for the Cardiac Rhythm and Heart Failure division of Medtronic.

For more information: www.medtronic.com

September 27, 2016 — In August, the European Heart Rhythm Association (EHRA) and EP Europace journal announced the release of the supplement to its ninth annual EHRA White Book, developed in partnership with Biotronik. The supplement was released just ahead of the 2016 European Society of Cardiology (ESC) Congress, Aug. 27-31 in Rome.

The 2016 EP Europace Supplement provides deeper analysis into data presented in the ninth annual EHRA White Book, which collects and distributes information on the yearly number of cardiac rhythm device implantations and catheter ablations in 50 of the 56 ESC member countries. Consistent with the findings of previous editions, the EHRA White Book 2016 found persistent inequalities across ESC countries in access to treatment for cardiac arrhythmias. It found many ESC countries, particularly in eastern Europe and those not on the European continent, fall behind western European countries in the use of implantable cardioverter defibrillators (ICDs) in a number of key arrhythmia treatments.

“Having this data helps us assess how well we’re able to treat groups of patients who may have been underserved in the past,” said 2016 EHRA White Book Coordinator Pekka Raatikainen, M.D., Finland. “We still need to address the disparities between countries in terms of access to all arrhythmia treatments, whether the issues have to do with finances, facilities, manpower or training. One of EHRA’s key goals is to reduce this gap in a number of ways, particularly through training and fellowships.”

The EHRA White Book 2016 also found an increase in the number of ablations for atrial fibrillation and ventricular tachycardia, as well as an increase in cardiac resynchronization therapy (CRT) and the use of insertable cardiac monitors (ICMs), among other findings. “It is particularly encouraging to see evidence that the number of ablations for atrial fibrillation continues to increase,” commented 2016 EHRA White Book Co-coordinator David O. Arnar, M.D., Iceland. “In combination with increasing ICM use, also documented in the EHRA White Book, we can not only treat patients, but monitor them continuously post-ablation to better gauge success rates.”

Biotronik has supported the EHRA White Book through an unrestricted educational grant since the first edition in 2008.

For more information: www.escardio.org

October 13, 2016 — Medtronic plc is the first company to receive U.S. Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines. This advancement gives patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.

Each year, approximately 12-16 percent of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1 percent receive a scan because of device or lead restrictions. Before the availability of MR-conditional technology, patients with cardiac devices were contraindicated from undergoing MRI scans to avoid a potential interaction between the MRI and the device function.

"The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians," said Marc Silver, M.D., cardiologist at WakeMed Heart and Vascular Physicians in Raleigh, N.C. "Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool."

MRI is an important imaging technology to diagnose conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain. 3T MRI offers better image quality, better diagnosis and reduced scan duration compared to 1.5T scans. In the next five years, the adoption of 3T MR systems is expected to reach approximately 30-40 percent of hospitals across the United States.

"While 1.5T scanners still comprise the majority of installations, 3T scanners are expected to comprise more than half of new units — with some centers having only 3T scanners — since they offer faster scans and higher resolution images," said Yair Safriel, M.D., neuroradiologist and chief medical officer at Pharmascan Clinical Trials and University of South Florida. "Approval for MRI-conditional scanning at both 1.5 and 3T allows patients to have improved access to MRI at a time and place most appropriate for their care. And with 3T scanning, physicians and radiologists gain a clearer look into soft tissues, particularly critical when diagnosing serious conditions, often involving the brain and spine."

Patients in the United States with the following devices are now eligible for 1.5 and 3T MRI scans:

• Advisa MRI pacemakers and Micra transcatheter pacemaker
• Amplia MRI and Compia MRI cardiac resynchronization therapy defibrillators
• Evera MRI and Visia AF MRI DF-1 and DF4 implantable cardioverter defibrillators
• Reveal LINQ insertable cardiac monitor
• SureScan pacing, defibrillation and left-heart leads

Additionally, Medtronic now offers more options for ICD patients undergoing device replacement surgery, enabling MRI access to an even broader base of patients.

For more information: www.medtronic.com

October 25, 2016 — St. Jude Medical is recalling 251,346 of its Fortify, Unify and Assura implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) because the batteries can deplete prematurely. 

St. Jude Medical is recalling certain models of the Fortify, Unify and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as lithium clusters) forming within the battery and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death. 

St. Jude Medical reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.

FDA and St. Jude Medical are alerting patients, patient-caregivers and physicians to respond immediately to elective replacement indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal three-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. 

Scope of Battery Depletion Issue

To date, St. Jude said of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters. Patient safety incidents related to this issue include: 

• Two deaths (one in the U.S.) have been associated with devices that could not provide needed shock therapy due to premature battery depletion.

• Ten patients (nine in the U.S.) have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.

• Thirty seven patients (30 in the U.S.) have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known, St, Jude said. At this time, 349,852 affected devices remain actively implanted worldwide.

Affected ICD and CRT-D Devices

The recall affects the Fortify, Unify, and Assura ICD CRT-D devices manufactured between January 2010 to May 2015. These devices were distributed between February 2010 to October 2016. Devices recalled in the U.S. alone total 251,346 nationwide, the FDA said. 

On Oct. 10, 2016, St. Jude Medical sent notification letters to customers and healthcare providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices. Additionally, on Oct. 11, the FDA issued a safety communication regarding this recall, and provided recommendations for healthcare providers, patients and caregivers.

Full List of Affected Devices includes:
• Fortify VR: Model No(s). CD1231-40, CD1231-40Q
• Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
• Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
• Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
• Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
• Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
• Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
• Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
• Unify: Model No(s). CD3231-40, CD3231-40Q
• Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
• Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
• Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
• Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C

Recommendations for Providers

• Do not implant unused affected devices. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.

• Communicate with all patients who have an affected device that their device has a battery that may run out earlier than expected. Consider giving patients the Dear Patient letter provided by St. Jude Medical.

• Continue to conduct follow-up on patients with affected devices using in-office visits in addition to remote monitoring once they have been notified of the battery issue. Increased in-office surveillance is not necessary for patients who are also followed with remote monitoring.

• Immediately replace the device at the time of an ERI alert. Currently, there is not a factor, method or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears.

• Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.

• Healthcare providers should consider whether elective device replacement is warranted for their pacemaker dependent patients. Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history comorbidities and condition.

• Most patients will not require prophylactic device replacement prior to ERI, as the rate of complications following replacement surgery are higher than those associated with premature battery depletion. However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.

• Enroll patients in Merlin@Home, St. Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognizing their device’s ERI alerts. For patients already enrolled in Merlin@Home, explain the importance of ongoing home monitoring. Utilize the “Direct Alerts” feature to provide you with an alert notification when a patient’s device has reached ERI. Please see additional information about the Merlin@Home Monitoring System below. If a home monitor is ordered for a patient with an affected device, St. Jude Medical will cover the cost of the home monitor.

• Ensure that the ERI battery alert is ON for all patients. Review the most recent “Programmed Parameters” printout.

• Review the “Trigger Alerts When” section, and ensure that the “Device at ERI” parameter is “on” for both the “Show on FastPath” and “Notify Patient” selections.

• If the “Device at ERI” alert is “off”, the patient should be seen promptly to program this parameter to “on”.

• Advise affected patients that an ERI alert triggers a vibratory notification and perform the following procedures at each scheduled office visit:
   1. Interrogate the patient’s device to determine if an ERI alert has been triggered. Premature battery depletion can be identified by health care providers through home monitoring showing ERI or more advanced battery depletion.
   2. Perform a patient notifier test to confirm that the patient feels and recognizes the vibratory alert.
   3. Patients who cannot feel the vibratory alert may experience loss of battery and/or loss of device function without their awareness. Advise the patient to contact your office promptly should they feel a vibratory alert. An in-office evaluation should be performed to determine the reason for the alert as other non-critical events can also trigger a vibratory alert.

St. Jude Contact and Additional Information

Customers with questions may contact St. Jude Medical Customer Service at (866) 915-5065.

Read more information from St. Jude Medical on the premature battery depletion issue

Read the Global Medical Advisory Concerning Subset of ICD and CRT-D Devices

Read the FDA’s safety communication

November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The Claria MRI CRT-D is approved for scanning in both 1.5 and 3 Tesla (T) magnetic resonance imaging (MRI) machines, and features EffectivCRT, a new algorithm that automatically tailors the therapy to individual patients by adjusting pacing rates.

"Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven't been able to determine if that stimulation actually improves the heart's pumping ability," said Suneet Mittal, M.D., director, electrophysiology laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, N.J. "With the Claria device, physicians are now able to verify the effectiveness of left ventricular pacing, which is especially beneficial for improving outcomes in patients with atrial fibrillation, who have been difficult to treat because this irregular and rapid heartbeat often interferes with the delivery of effective CRT."

A large percentage of heart failure patients receiving cardiac resynchronization therapy have atrial fibrillation (AF),1 which can significantly reduce patient response to CRT. The Claria device includes the Medtronic-exclusive EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during AF, without adversely affecting the average heart rate.

Additional features on the Claria device include:

• The AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59 percent,2 and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing;3
• VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,4 and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient;
• Attain Perfoma MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce phrenic nerve stimulation occurrence,5 steroid on all electrodes, and three shapes for varying patient anatomies; and
• SureScan MR-conditional labeling for full-body scans without positioning restrictions. Medtronic now offers MR-conditional pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs) and CRT-Ds. Additionally, patients with certain existing defibrillation leads will be eligible for an MR-conditional ICD or CRT-D, and thus able to access this important imaging technology.

Medtronic also has submitted a Pre-Market Application (PMA) to the FDA for Multiple Point Pacing, which, if approved, would be available with the Claria MRI and Amplia MRI CRT-Ds.

For more information: www.medtronic.com

References

1 Kloosterman M, Maass AH, Rienstra M, Van Gelder IC. Atrial fibrillation during cardiac resynchronization therapy. Card Electrophysiol Clin. December 2015;7(4):735-748.
2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
3 Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
4 Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
5 Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study. Circulation Arrhythmia and Electrophysiology. 2012.

January 9, 2017 — The U.S. Food and Drug Administration (FDA) issued a safety communication today concerning patient safety issues due to cybersecurity vulnerabilities found in St. Jude Medical's radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter. The FDA said it has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks.

The FDA said there have been no reports of patient harm related to these cybersecurity vulnerabilities. St. Jude Medical said it is not aware of any cyber security incidents related to a St. Jude Medical device, nor is it aware that any specific St. Jude Medical device or system in clinical use has been purposely targeted. 

St. Jude Medical said it is now deploying the latest release of cyber security updates for its Merlin remote monitoring system that is used with implantable pacemakers and defibrillator devices. The improvements include security updates that complement the company’s existing measures and further reduce the extremely low cyber security risks. The company developed and validated a software patch for the Merlin@home Transmitter that addresses and reduces the risk of specific cybersecurity vulnerabilities. The patch, which will be available beginning Jan. 9, 2017, will be applied automatically to the Merlin@home Transmitter. Patients and patient caregivers only need to make sure their Merlin@home Transmitter remains plugged in and connected to the Merlin.net network to receive the patch. The FDA has reviewed St. Jude Medical's software patch to ensure that it addresses the greatest risks posed by these cybersecurity vulnerabilities, and reduces the risk of exploitation and subsequent patient harm. The FDA conducted an assessment of the benefits and risks of using the Merlin@home Transmitter, and has determined that the health benefits to patients from continued use of the device outweigh the cybersecurity risks.

“There has been a great deal of attention on medical device security and it’s critical that the entire industry continually enhances and improves security while bringing advanced care to patients,” said cybersecurity expert Ann Barron DiCamillo, former director of U.S. CERT and advisor to St. Jude Medical’s Cyber Security Medical Advisory Board. “Today’s announcement is another demonstration that St. Jude Medical takes cybersecurity seriously and is continuously reassessing and updating its devices and systems, as appropriate.”

“We’ve partnered with agencies such as the U.S. Food and Drug Administration and the U.S. Department of Homeland Security Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) unit and are continuously reassessing and updating our devices and systems, as appropriate,” said Phil Ebeling, vice president and chief technology officer at St. Jude Medical.

The FDA said will continue to assess new information concerning the cybersecurity of St. Jude Medical's implantable cardiac devices and the Merlin@home Transmitter, and will keep the public informed if the FDA's recommendations change. The FDA reminds patients, patient caregivers and healthcare providers that any medical device connected to a communications network (e.g. wi-fi, public or home Internet) may have cybersecurity vulnerabilities that could be exploited by unauthorized users. The increased use of wireless technology and software in medical devices, however, can also often offer safer, more efficient, convenient and timely health care delivery.The FDA will continue its work with manufacturers and health care delivery organizations—as well as security researchers and other government agencies—to develop and implement solutions to address cybersecurity issues throughout a device's total product lifecycle. The FDA takes reports of vulnerabilities in medical devices very seriously and has issued recommendations to manufacturers for continued monitoring, reporting and remediation of medical device cybersecurity vulnerabilities.

The issue of St. Jude electrophysiology device cyber vulnerabilities was raised in 2016 by a medical device market research firm that published a report alleging these vulnerabilities existed specifically in St. Jude Medical's implantable electrophysiology (EP) devices. Read the article "Market Report Calls Into Question St. Jude Medical EP Device Safety, Cybersecurity." St. Jude filed a lawsuit against the firm and said in statements the concerns the report raised were not valid or accurate. However, the FDA safety communication seems to contradict the company's defensive reaction and lend some validity to the market report.

“As medical technology advances, it’s increasingly important to understand how innovation and cybersecurity impact physicians and the patients we treat,” said Leslie Saxon, M.D., chair of St. Jude Medical’s Cyber Security Medical Advisory Board. “We are committed to working to proactively address cybersecurity risks in medical devices while preserving the proven benefits of remote monitoring to assess patient status and device function.”

St. Jude Medical was acquired by Abbott as of Jan. 4, 2017.

FDA Wants to Expand Review of Cybersecurity Issues With Medical Devices
The FDA warns that cybersecurity breaches are not limited to St. Jude devices. There are several other wireless systems that interface with implantable EP devices from Medtronic, Boston Scientific and Biotronik. The FDA said as wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless connectivity to extract patient information and change the device functionality, there are growing concerns these technologies will be be targets of hackers. The U.S. Food and Drug Administration (FDA) believes this poses a threat to patient safety. The agency announced in December the availability of the guidance document entitled "Postmarket Management of Cybersecurity in Medical Devices."

The FDA issued this guidance to inform industry and FDA staff of the agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.

Read the article “FDA Seeks Management of Cybersecurity in Medical Devices.”
 

Recommendations for HealthCare Providers
Continue to conduct in-office follow-up, per normal routine, with patients who have an implantable cardiac device that is monitored using the Merlin@home Transmitter.

Remind patients to keep their Merlin@home Transmitter connected as this will ensure that patients' devices receive the necessary patches and updates.

Contact St. Jude Medical's Merlin@home customer service at 1-877-My-Merlin, or visit www.sjm.com/Merlindisclaimer icon for answers to questions and additional information regarding St. Jude Medical's implantable cardiac devices, or the Merlin@home Transmitter.

Recommendations for Patients and Caregivers
The FDA says to follow the labeling instructions provided with the Merlin@home Transmitter. Patients should peeping monitor connected as directed so the monitor receives necessary updates and patches. Keep in mind that although all connected medical devices, including this one, carry certain risks, the FDA has determined that the benefits to patients from continued use of the device outweigh any risks.

Patients should consult with their physician(s) for routine care and follow-up. Your ongoing medical management should be individualized based on your medical history and clinical condition.

Patients should seek immediate medical attention if symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath occur.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report

For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm535979.htm

March 7, 2017 — Medtronic plc recently announced an economic analysis of five-year data showing that patients with mild heart failure who get cardiac resynchronization therapy (CRT) devices early in their treatment live longer. The analysis also showed that implanting these devices is cost-effective, compared to optimal medical therapy. Results from the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) trial were published in the Journal of the American College of Cardiology: Heart Failure.

CRT is an established treatment for indicated patients with heart failure that has been demonstrated to improve survival and quality of life, and reduce hospitalizations. However, despite significant clinical evidence and guideline recommendations in support of CRT, studies have shown the therapy to be underutilized in eligible patients.

REVERSE is the largest study to assess the long-term clinical impact and survival benefit of devices combining CRT with a defibrillator compared with CRT pacemakers. It is also the first study to show the cost-effectiveness of CRT when implanted earlier in the disease state, according to Medtronic.

"These new data expand upon the current evidence and guidelines for the treatment of heart failure, by showing that CRT in patients with mildly symptomatic heart failure is beneficial, both from a clinical perspective, as well as from a financial perspective," said Michael R. Gold, M.D., Ph.D., chief of cardiology, Michael E. Assey Professor of Medicine at the Medical University of South Carolina. "REVERSE confirms that implanting CRT earlier slows the progression of heart failure, reduces heart failure-related hospitalizations and deaths, and prolongs life, all while being very cost-effective."

REVERSE was a prospective, randomized, double-blind study of 610 patients with mild heart failure (those designated New York Heart Association Class I/II) from North America and Europe. All patients were implanted with a CRT-pacemaker (CRT-P) or -defibrillator (CRT-D) and randomly assigned (2:1) to either CRT-ON or CRT-OFF.

Previously published REVERSE findings showed a trend that CRT-ON increased survival by nearly 23 percent (52.5 percent vs. 29.7 percent, p=0.21), leading to an expected survival rate of 9.76 years for CRT-ON versus 7.5 years for CRT-OFF.

Based on these findings, the new analysis shows, for the first time under the Medicare setting, that CRT is a cost-effective option for patients with mild heart failure: CRT-ON yields an incremental cost effectiveness ratio (ICER) of $8,840 per Quality-Adjusted Life Year (QALY) gained over a patient's lifetime, compared to CRT-OFF. (ICER is a statistic that summarizes the cost-effectiveness of a healthcare intervention, and QALY is a measure of the quantity and quality of life.)

Additionally, REVERSE has shown that CRT-D provides a significant improvement in survival — 2.77 additional years of life — compared to CRT-P devices. This benefit results in a first-of-its-kind finding that CRT-D is a cost-effective alternative to CRT-P, yielding an ICER of $43,678/QALY gained over the patient's lifetime, lower than the benchmark for therapy cost effectiveness of other serious chronic conditions that cost at least $50,000 per QALY gained. Thus, while CRT-D costs more than CRT-P, the added 2.77 years of life justify the additional cost over a patient's lifetime.

Finally, these analyses show CRT delays disease progression, which means that initially implanting a CRT-D is essentially cost-neutral compared to implanting an ICD and implanting a CRT-D later, when the disease worsens. With early CRT-D implantation slowing disease progress and increasing survival, and without any discounting of future benefits and cost applied, early CRT-D led to 1.24 years of additional survival, resulting in an ICER of $1,829 per year of life gained.

For more information: www.heartfailure.onlinejacc.org

References

Sutton, M.J., Linde, C., Gold, M.R., Abraham, W.T., et al. "Left Ventricular Architecture, Long-Term Reverse Remodeling, and Clinical Outcome in Mild Heart Failure With Cardiac Resynchronization,"JACC: Heart Failure. Published March 2017. DOI: 10.1016/j.jchf.2016.11.012

March 23, 2017 — Biotronik announced the European launch of the Edora series, its smallest series of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The new devices are equipped with features geared towards improving patient safety, therapy and comfort. Moreover, Edora pacemakers are significantly smaller and lighter than preceding models, achieving compactness and full functionality without compromising battery life.

“Biotronik’s new series of pacemakers fits well in the current age of smart technologies, with devices that are smaller, lighter and shorter while retaining longevity,” stated Saravanan AL Krishinan, M.D., Hospital Sultanah Bahiyah, Alor Setar, Malaysia. "What's more, the devices offer simplified MRI [magnetic resonance imaging] access, which is often crucial for better patient care.”

To facilitate patient access to MRI, Edora pacemakers and CRT-Ps are MR-conditional and feature Biotronik’s MRI AutoDetect functionality. This means that within a programmable window of up to 14 days, the device’s built-in sensor can detect an MRI environment and automatically switch the system to MRI mode; the device then automatically switch back to its standard mode once the scan is complete. Since the device is only in MRI mode for the duration of the scan, the patient receives optimal therapy for the maximum amount of time.

Devices in the Edora series also support Biotronik Home Monitoring for remote long-term patient care with a streamlined workflow. Biotronik Home Monitoring automatically collects cardiovascular data from the patient’s device on a daily basis and transmits it remotely to the physician without the need for any patient interaction. This facilitates the early detection of arrhythmias, with clinical trial results demonstrating that the monitoring system significantly reduces hospitalization for atrial arrhythmia and related stroke in pacemaker patients.

Edora CRT-Ps are specifically tailored for individualized therapy through quadripolar technology for flexible pacing in the left ventricle (LV). This is complemented by a comprehensive LV lead portfolio, which caters for diverse patient anatomies.

This product is currently only approved for use in the European Economic Area. The company expects to announce FDA approval in the second quarter of 2017. 

For more information: www.biotronik.com

April 14, 2017 — The National Institute for Health and Care Excellence (NICE) recently issued medical technology guidance recommending the use of Boston Scientific Corp. cardiac resynchronization therapy defibrillators (CRT-D) powered by EnduraLife Battery Technology for treating patients with heart failure.

In their evaluation, NICE – which provides evidenced-based guidance to improve health and social care in the National Health Service (NHS) in the United Kingdom – concluded that the extended battery life observed with Boston Scientific EnduraLife-powered CRT-Ds is likely to reduce the number of avoidable replacement procedures a patient may have to undergo, thereby offering improved outcomes for patients and potential savings to the NHS in England of approximately £6 million in the first five years.

The savings were calculated by modeling the costs associated with early replacement procedures, such as a reduction in hospital admissions, bed days and procurement costs. Fewer replacement procedures also equate to a reduction in associated costs accrued from post-operative complications and infections – both of which also have a measurable impact on morbidity and mortality.

"The NICE guidance reinforces the multi-faceted importance of battery longevity in devices treating patients with heart failure and life-threatening ventricular arrhythmias," said Jay Wright, M.D., consultant cardiologist, Liverpool Heart and Chest Hospital, Liverpool, U.K. "Additionally, the reduction in replacement procedures and potential savings identified within the guidance could offer longer-term relief to NHS providers who have recently seen an increase in the number of patients requiring further in-hospital treatment." 

The NICE medical technologies advisory committee found that the evidence from 16 independent clinical and economic studies supported a case for adoption. The committee concluded that EnduraLife-powered CRT-Ds have a greater battery capacity and longer battery life compared with other CRT-Ds reviewed.

The full guidance document can be read here.

For more information: www.bostonscientific.com

May 12, 2017 – New study proves safety of novel, wireless pacing system, WiSE CRT (Wireless Stimulation Endocardially for cardiac resynchronization therapy) two years after implantation. The study is the first to report on the medium-long term feasibility of the EBR WiSE cardiac resynchronization therapy (CRT) leadless pacing system for heart failure patients and was presented at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions. 

The WiSE-CRT is currently the only wireless, endocardial (inside the heart) pacing system for stimulating the heart’s left ventricle (LV). The implant is roughly the size of a large grain of rice and uses ultrasound technology to transfer energy from a subcutaneous pulse generator to a receiver-electrode implanted on the LV endocardial wall.

The multicenter study was conducted in various locations across Europe including the United Kingdom, Germany, Czech Republic and Denmark. Researchers enrolled a total of 33 patients that underwent implantation. Prior to the study, all patients experienced progressive heart failure with no response to conventional CRT treatment therapy.

LV capture was possible in all cases throughout the study. The average mega joule (mJ) required for electrical capture was 0.38, 0.36, 0.33, 0.37, 0.19 and 0.25 at one week, one, two and six months, and at one and two years, respectively. The two-year threshold trend was found to be similar to those for conventional pacing system. 

“The results are very encouraging because it’s the first time we are seeing the long-term outcome of this wireless pacing system and was demonstrated to be safe and feasible for heart failure devices,” said lead author, Simon James, MRCP, electrophysiologist, James Cook University Hospital in Middlesbrough, United Kingdom. “By eliminating the challenges that come with leads seen in a conventional pacing system, this novel device provides a new treatment alternative that has the potential to improve the patient’s overall quality of life.”

Study authors note that there is interest to further test the long-term efficacy with WiSE-CRT and review the results on a larger number of patients. There is currently a clinical trial taking place to test the safety and effectiveness of the device specifically in the United States.

Read about the U.S. trial in the article “FDA Approves U.S. Study of EBR Systems' Wireless Cardiac Pacing System.”

Approximately 26 million people worldwide are living with heart failure.[1] Successful CRT therapy can help reduce heart failure symptoms, hospitalizations, and mortality by synchronizing the left and right ventricles. Although traditional CRT systems are widely used in patients, approximately 30 percent of patients – and as high as 40 percent to 50 percent in some studies – do not respond to this conventional therapy.[2] There are leads in conventional CRT systems and that can increase the risk of infection due to a physical connection from the heart to externalized (outside the blood stream) components and the restricted choice of electrode site can result in failure for patients to benefit.

For more information: www.HRSonline.org, www.hrssessions.org

References:

1. Ponikowski, Piotr, Stefan D. Anker, Khalid F. AlHabib, Martin R. Cowie, Thomas Force, Shengshou Hu, Tiny Jaarsma, Henry Krum, Vishal Rastogi, Luis E. Rohde, Umesh C. Samal, Hiroaki Shimokawa, Bambang Budi Siswanto, Karen Silwa, and Gerasimon Filippatos." Heart Failure: Preventing Disease and Death Worldwide." (n.d.): n. pag. 15 May 2014. Web.

2. Leeor M. Jaffe and Daniel P. Morin. "Cardiac Resynchronization Therapy: History, Present Status, and Future Directions." The Ochsner Journal (2014): 596-607. Web.

3.  Simon James, Darragh J. Twomey, Christian Butter, Sam Riahi, and Andrew Turley. Heart Rhythm 2017 meeting session, “Contemporary Considerations in CRT: Left Ventricular Endocardial Pacing with a Novel Wireless CRT System (WiSE-CRT): Pacing Threshold Trends: Medium Term 2-Year Data.” Presented May 12, 2017.

May 9, 2017 — The U.S. Food and Drug Administration (FDA) has cleared Boston Scientific’s Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The approval includes new features in the Resonate devices including SmartCRT technology with multisite pacing capability for multi-electrode pacing, and compatibility with the HeartLogic Heart Failure Diagnostic Service to help physicians improve heart failure (HF) management.

All Resonate devices are powered by the company's EnduraLife battery technology, which has nearly two times the usable battery capacity as certain competitive devices,[1,2] an essential factor when considering the lifelong needs of patients receiving ICD or CRT therapy. Recent guidance issued by the National Institute for Health and Care Excellence (NICE) in March 2017 recommended the use of EnduraLife-powered CRT-Ds to reduce the number of avoidable replacement procedures a patient may have to undergo, thereby offering improved outcomes for patients and potential savings to the National Health Service (NHS) in England of approximately £6 million in the first five years.

The company has initiated a series of clinical trials, the SMART Registry, SMART CRT Study and SMART MSP, to demonstrate improved response to CRT therapy with SmartCRT technology, which helps physicians optimize where, when, and how to pace the lower chambers of the heart.

"These trials will add to the body of evidence showing CRT therapy can be tailored to individual patient characteristics at the time of implant, while adjusting device programming solutions over the life of the device without fear of adversely draining the device battery and causing unnecessary replacement procedures," said Michael Gold, M.D., principal investigator of the SMART CRT study and the Michael E. Assey professor of medicine at The Medical University of South Carolina, Charleston, S.C.

"We are changing the treatment landscape by combining industry-leading device longevity with innovative solutions that will provide clinicians with tools to manage heart failure more effectively," said Kenneth Stein, M.D., senior vice president and chief medical officer, rhythm management and global health policy, Boston Scientific. "Our post-approval studies for the HeartLogic service, including MANAGE-HF, will gather additional evidence to illustrate how these alerts, which detect impending heart failure decompensation, can improve patient outcomes." 

This FDA approval follows on the February 2017 CE mark and subsequent commercialization for the Resonate family of ICD and CRT-D devices.

For more information: www.bostonscientific.com

References:

1. Medtronic Evera XT VR DVBB2D4 Device Manual page 25. 

2. Boston Scientific Implantable Cardioverter Defibrillator Physician's Technical Manual 359050-003 EN US 2014-01 page 30. 

May 9, 2017 — Biotronik announced U.S. Food and Drug Administration (FDA) approval and the launch of Sentus ProMRI, the thinnest quadripolar left ventricular lead available in the United States. This introduction completes Biotronik's second-generation ProMRI lead portfolio, which also includes Solia ProMRI and Plexa ProMRI.

Sentus ProMRI is approved for use with heart failure devices based on data collected during the QP ExCELs study. The study, which included 53 sites in the United States, demonstrated Sentus ProMRI QP's performance. Key data points included:

• Complication-free rate of 97.1 percent at six months;
• Lead dislodgement rate of 1.43 percent; and
• Achievement of permanent pacing vector pacing threshold lower than 2.5 V for 93.4 percent of subjects at three months.

Sentus ProMRI is a quadripolar coronary sinus left ventricular (LV) lead with an isodiametric design that marries co-radial wire insulation technology and polyurethane coating for maximum flexibility and reduced friction. The lead's four electrodes feature Biotronik’s fractal iridium coating to maximize performance.

"With the array of leads available today, every patient should be implanted with an MR conditional device," said Venkat R. Iyer, M.D., electrophysiologist at Bayview Physicians Group in Norfolk, Va. "Our patients deserve nothing less than the best possible care. With MR [magnetic resonance] conditional solutions, we can help ensure this continues throughout the patient care journey."

Sentus ProMRI completes the ProMRI quadripolar system when used with Biotronik's Inventra HF-T QP cardiac resynchronization therapy defibrillator (CRT-D). This makes it the only MR conditional heart failure solution available in the United States that delivers ultra-high energy (42J) therapy on the first and every shock, according to the company. This system offers Closed Loop Stimulation (CLS) — Biotronik’s physiologic rate-adaptive algorithm that automatically optimizes to each patient's needs based on real-time metabolic demand. It also features Biotronik Home Monitoring, which has shown a 50 percent reduction in mortality1 in patients with heart failure, as proven in the IN-TIME study.

For more information: www.biotronik.com

Reference
1. Hindricks G, et al. The Lancet. 2014, 384 (9943).

May 10, 2017 —  Biotronik announced the availability of the first U.S. Food and Drug Administration (FDA)-approved cardiac rhythm management (CRM) devices with technology that automatically recognizes when a patient enters a magnetic resonance imaging (MRI) environment.

Biotronik's MRI AutoDetect technology ensures patients with CRM devices can safely undergo MRI scans while minimizing programming burdens for hospitals. Once activated by a physician, MRI AutoDetect can automatically recognize when the patient enters an MRI environment and convert the device to MRI mode. When the scan is complete, MRI AutoDetect automatically returns the device to its permanent program. Physicians can program MRI AutoDetect to be active for up to 14 days, allowing patients the flexibility to undergo, reschedule or repeat MRI scans as needed during the set timeframe.

MRI AutoDetect is currently available on Biotronik's newest line of CRM devices, including the Ilivia series for tachycardia.

The company will highlight its CRM solutions at the Heart Rhythm Society's (HRS) 38th Annual Scientific Sessions, May 10-13 in Chicago.

For more information: www.biotronik.com

May 11, 2017 — Biotronik announced U.S. Food and Drug Administration (FDA) approval of the company's MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT). MPP will be available on new Biotronik CRT defibrillator (CRT-D) systems for patients with heart failure.

Nearly 40 percent of heart failure patients are initially non-responsive to CRT. Biotronik's MPP technology addresses this challenge by enabling the left ventricle to be paced twice per cardiac cycle. Uniquely, these paces can be either sequential or simultaneous, allowing for greater customization of therapy to meet specific patient needs. The company’s CRT-D systems include MPP and feature ProMRI technology, providing patients with access to critical diagnostic imaging scans as needed. These devices are also equipped with MRI AutoDetect, a dedicated sensor that detects the magnetic resonance imaging (MRI) environment, converts the patient's device to MRI mode, and then automatically returns to its permanent program when the scan is complete.

"MultiPole Pacing is an important technology that allows physicians to tailor cardiac resynchronization therapy to each patient," said Gery Tomassoni, M.D., Baptist Health, Lexington, Ky. "Heart failure is a complex condition and physicians are routinely challenged to find the ideal treatment for unique disease presentations. Adding MPP technology to other key Biotronik features creates more options for physicians to meet evolving patient needs."

Biotronik will feature MPP and other 360° CRT solutions at the 2017 Heart Rhythm Society (HRS) Annual Meeting, May 10-13 in Chicago.

For more information: www.biotronik.com

May 15, 2017 – The U.S. Food and Drug Administration (FDA) has granted market clearance Medtronic’s portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure. These devices also allow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines. The Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan and Solara Quad CRT-P MRI SureScan are expected to be available commercially in the United States in early summer 2017. 

“These new pacemakers allow clinicians to provide more personalized therapy treatment options,” said Anne B. Curtis, M.D., chair of the Department of Medicine, University at Buffalo, N.Y. “Their ability to automatically adjust pacing to meet the patient’s needs, even those who are among the most difficult to treat, is an example of how advanced implanted heart device technology has become.”
 
The Percepta Quad CRT-P features the EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during atrial fibrillation (AF). It also includes VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes,[1] and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.
 
The Percepta Quad and Serena Quad CRT-Ps also feature the Medtronic-exclusive AdaptivCRT algorithm, which reduces a patient’s odds of a 30-day heart failure readmission by 59 percent,[2] and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing.[3] Multiple point pacing, which can stimulate the left ventricle (lower chamber) at two sites, is also available on both devices, as well as on the company’s Claria MRI Quad CRT-D SureScan and Amplia MRI Quad CRT-D SureScan.
 
All three CRT-Ps also are compatible with Attain Performa MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce the occurrence of phrenic nerve stimulation,[4] steroid on all electrodes, and three shapes for varying patient anatomies. They also employ the Medtronic-exclusive PhysioCurve contoured design, which reduces overall skin pressure compared to non-contoured devices,[5] for enhanced patient comfort6 and improved cosmetic appearance of the implant site7. This CRT-P portfolio received CE (Conformité Européenne) mark in February 2017.
  
For more information: www.medtronic.com

References:
1. Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
2. Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
3. Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
4. Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study. Circulation Arrhythmia and Electrophysiology. 2012.
5. Flo D, et al. IS4/DF4 Device Shape Analysis. Medtronic data on file. January 2013. 
6. Ceelen KK, et al. J Biomech. 2008;41:3399-3404.
7. Gold MR, et al. J Am Coll Cardiol. 1996;28;1278-1282.