Cameron Health Reaches 1,000 Patient Milestone for S-ICD® System
Cameron Health, Inc. announced that the 1,000th patient was recently implanted with the S-ICD® System, the world’s only completely subcutaneous implantable defibrillator.
The 1,000th patient was implanted by Lara Dabiri Abkenari, MD, in association with Professor Luc Jordaens, MD, PhD, at the Erasmus Medical Center in Rotterdam, the Netherlands. Professor Jordaens remarked, “We have gained significant insight into this new technology over the past two years and are encouraged by the results. The avoidance of transvenous lead placement has significant implications for both short- and long-term complication rates.”
“Our experience with these first 1,000 patients has confirmed that the S-ICD System is a valuable new treatment option for both primary and secondary prevention patients at risk of sudden cardiac arrest. In addition, the S-ICD System provides an important alternative for patients that are not candidates for conventional transvenous ICD systems,” said Kevin Hykes, Cameron Health’s President and CEO.
“The S-ICD System has the inherent advantage of not requiring an electrode inside of the heart,” said Reinoud Knops, MD, at the Amsterdam Medical Center, the Netherlands. “It will be important to investigate how the less-invasive approach of the S-ICD System will impact the rate of serious complications in comparison to traditional transvenous ICD systems.”
In order to evaluate the performance of the S-ICD System in the real-world setting, Cameron Health recently initiated the EFFORTLESS™ Registry in Europe and New Zealand. EFFORTLESS will follow the S-ICD System in 1,000 patients for a period of 60 months post implant.
In the U.S., Cameron Health plans to submit clinical data from its recently completed, 330-patient S-ICD System Pivotal IDE Clinical Study to the FDA in early 2012.
About the S-ICD System
The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, removing the need for lead placement inside the heart. Essentially, the S-ICD System eliminates the major risks associated with transvenous leads. The S-ICD System detects highly accelerated and disorganized heart rhythms caused by ventricular arrhythmias that can lead to sudden cardiac arrest. When abnormal arrhythmias are detected, the S-ICD System delivers an 80-joule shock to restore the heart’s normal rhythm. Left unaddressed, these disorganized heart rhythms are often fatal.
FDA Advisory Panel Recommends Expanded Indication for Medtronic Cardiac Resynchronization Therapy with Defibrillator Devices
Medtronic, Inc. announced that the U.S. Food and Drug Administration’s (FDA) Circulatory Systems Devices Advisory Panel determined that the overall clinical benefits of Medtronic cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices outweigh the risks in treating certain mildly symptomatic heart failure patients. The recommendation, which was based on data from the landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) and REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) clinical trials, pave the way for a potential expanded labeling approval for these devices. While Medtronic’s CRT-Ds are currently approved for patients with moderate-to-severe heart failure, these pivotal studies show their use can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.
Specifically, the Advisory Panel voted in favor of the CRT-D devices’ strong safety (Yes: 5 votes, No: 0 votes) and efficacy (Yes: 3 votes, No: 2 votes) profile in treating a mildly symptomatic patient population. The panel voted in favor of the overall risk-benefit profile (Yes: 3 votes and No: 2 votes). The FDA will consider the Panel’s feedback as it reviews Medtronic’s request to expand its CRT-D indication to include New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 120 milliseconds.
“Today’s favorable Panel vote brings us one step closer to providing more heart failure patients with advanced treatment options that are proven safe and effective and can significantly improve survival and quality of life,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “We look forward to working closely with the FDA during the regulatory process so that we may expand the use of our innovative portfolio of CRT-D devices in an effort to enhance patient outcomes in a broader heart failure population.”
While certain NYHA Class II patients are already indicated for an implantable cardioverter defibrillator (ICD) to protect them from sudden cardiac arrest, they are still vulnerable to experiencing an exacerbation of their heart failure. However, a growing body of clinical evidence suggests that earlier intervention with CRT-D can decrease the risk of morbidity and mortality in this mildly symptomatic patient population. CRT-D therapy works by resynchronizing the contractions of both ventricles by sending tiny electrical impulses to the heart muscles, which improves the heart’s blood-pumping ability. The device also has defibrillation capability, allowing for termination of life-threatening ventricular arrhythmias.
“As was seen in the RAFT and REVERSE trials, clinical evidence demonstrates that CRT-D prevents hospitalization and can save lives in mildly symptomatic patients,” said Michael R. Gold, MD, PhD, REVERSE study investigator and steering committee member, Michael E. Assay, professor of medicine and director of cardiology at the Medical University of South Carolina. “Utilizing this lifesaving therapy earlier in a milder heart failure population would allow us to treat these patients before their symptoms exacerbate, ultimately enabling us to better address this serious, often debilitating and costly disease.”
RAFT Clinical Trial
Findings from the landmark RAFT clinical trial, published in the New England Journal of Medicine, showed that CRT-D significantly reduced mortality for mildly symptomatic heart failure patients (NYHA Class II) by 29 percent when compared to patients treated with guideline-recommended implantable ICDs and medical therapy (p = 0.006; HR = 0.71). The study also demonstrated a significant reduction (27 percent) in combined mortality and heart failure hospitalizations for this population (p = 0.001; HR = 0.73), consistent with previously published studies. All patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any study of CRT therapy.
REVERSE Clinical Trial
With 610 patients studied, REVERSE was the first large-scale, global, randomized, double-blind trial to demonstrate the impact of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. All of the randomized subjects received a Clinical Composite Response at 12 months. The Clinical Investigation Plan pre-specified that a comparison would be made between subjects with CRT and those without. The results showed that 21 percent of subjects without CRT worsened, compared with 16 percent with CRT (p = 0.10).
In a post-hoc analysis, more patients in the trial improved with CRT than without (54 percent vs. 40 percent, respectively). The Clinical Composite Response measure for heart failure consists of several different endpoints, including death, hospitalization for heart failure, crossover to the opposite arm due to worsening heart failure, a progression to a worsened NYHA class, or a moderate or marked worsening of the patient’s self-assessment (administered by the blinded clinician). Furthermore, the analysis of secondary endpoints in the REVERSE trial showed that CRT leads to improvement in both cardiac structure and function as measured by echocardiography, meaning the heart size improves and beats more effectively. In an additional analysis, REVERSE also demonstrated that CRT delayed the time to first heart failure hospitalization in this patient group and reduced hospitalization or death by 51 percent.
The use of Medtronic CRT-D devices for mildly symptomatic heart failure patients (NYHA Class II) is investigational and not an approved use in the United States. Medtronic has supported seven major heart failure trials evaluating CRT that have contributed to the continued development and broadening of treatment guidelines.
Buffalo Heart Group Investigates Early Heart Attack Detection Device Developed by Angel Medical Systems
Dr. Zaki Masud, from Kaleida Health in Buffalo, New York, announced the first implant of the AngelMed Guardian cardiac monitor and alert system. The system is designed to reduce the time it takes patients to get to the emergency room during an impending heart attack. Dr. Hashmat Ashraf performed the first implant in the state of New York, and is among the very first physicians across the United States to implant the experimental device.
The AngelMed Guardian system is designed to track significant changes in the heart’s electrical signal and then alert patients to seek medical attention. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.
David Garland, a 7th grade teacher at JFK in Buffalo, is the first patient in New York enrolled in the ALERTS study to receive the AngelMed Guardian System. David had a heart attack in July and underwent stent placement. He has a strong family history of heart disease; his symptoms included fatigue and “indigestion-like” pain and had symptoms for weeks before his heart attack.
David Garland was successfully implanted with the device by Dr. Ashraf of Kaleida Health, Millard Fillmore Gates Hospital.
According to the American Heart Association, one of every five deaths in the U.S. is attributable to coronary heart disease. Furthermore, 50% of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.
The AngelMed Guardian System is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals.
Buffalo Heart Group is among the first medical facilities to participate in the AngelMed Guardian system trial. To participate in the ALERTS study, patients must meet various inclusion criteria. For more information on the AngelMed Guardian system or the ALERTS study protocol, contact Marcia Makoviecki of Angel Medical Systems at: (732) 542-5551 x205.
FDA Advisory Panel Recommends Against Approval of Champion® Heart Failure Management System for Patients With Heart Failure
CardioMEMS announced that the U.S. Food and Drug Administration’s (FDA) Circulatory Systems Devices advisory panel voted against the Champion Heart Failure Monitoring System, the first wireless, permanently implantable device that allows cardiologists to monitor heart failure patients from their homes. While the panel agreed that the CardioMEMS technology is safe with a vote of 9-1, the majority did not vote positively that the System is effective and that reasonable assurance of the risks associated with the device outweigh the potential clinical benefits of the technology.
The committee recommendation, although not binding, will be considered by the FDA as it reviews the pre-market approval application for the Champion HF Monitoring System. CardioMEMS submitted a modular pre-market approval (PMA) application with the last submission completed in April 2011 based on data from its CHAMPION clinical trial.
CardioMEMS CEO and Founder, Jay Yadav, MD, commented, “While we are disappointed with today’s outcome, we look forward to continuing discussions with the FDA to determine the best path forward. We believe this technology is a significant step forward in the management of heart failure patients.”
The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial demonstrated a 28% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 37% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment. The CHAMPION Trial met all of its safety and secondary efficacy endpoints.
About CardioMEMS, Inc.
CardioMEMS is a medical device company that has developed and is commercializing proprietary wireless sensing and communication technology for the human body. The company’s technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. CardioMEMS miniature wireless sensors can be implanted using minimally-invasive techniques and transmit cardiac output, blood pressure and heart rate data which are critical to the management of patients. The sensors are designed to be permanently implanted into the heart and blood vessels due to their small size, durability and lack of wires and batteries. Using radiofrequency energy, the sensors transmit real-time data to external electronic readers, which then communicate this information to the patient’s physician. The company developed this technology based on the belief that frequent, on-demand, real-time monitoring of vital information enables proactive patient management, which holds the promise of reducing hospitalizations, improving a patient’s quality of life and delivering more efficient and cost effective health care.
CardioMEMS, Champion and the CardioMEMS logo are registered trademarks of CardioMEMS, Inc.
Caution: The Champion Heart Failure Monitoring System is an investigational device limited by federal law to investigational use.