The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 7-1 that the benefits of Cameron Health’s subcutaneous implantable cardioverter defibrillator outweigh the risks when used in the appropriate patient population.
In a 7-1 vote, panel members deemed the device effective and unanimously agreed that it is safe in patients for whom the device is indicated.
“The operational word here is reasonable assurance of safety and effectiveness,”John C. Somberg, MD, of the Rush University Medical Center, said. “We have an expedited review and a small patient population that I believe is reasonable.”
However, David Milan, MD, of Massachusetts General Hospital and Harvard Medical School, said it is important to balance the enthusiasm for a new technology with caution to ensure that standards for efficacy remain high.
The committee also discussed the adequacy of the proposed post-approval study. It will be an observational registry of patients who were initially implanted with a subcutaneous ICD system in the premarket clinical study. A minimum of 650 patients will be enrolled and the study is designed to assess the device’s complication-free rate at 36 months.
“I think this is something some of us have been waiting a very long time for,” Pamela E. Karasik, MD, of the Veteran’s Administration Hospital, said. “We all recognize the need for a non-transvenous system. It’s very exciting to have this innovation. I think only time will tell if it’s embraced by the electrophysiology population, whether we actually adopt using it in a relatively short period of time, and whether we know if this works for our patients or not.”
Intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, the subcutaneous ICD is capable of delivering high energy defibrillation shocks a well as bradycardia demand mode cardiac pacing. It is also the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. Since July 2009, the subcutaneous ICD system has been distributed commercially outside the United States.
Although the FDA is not required to follow the recommendations of the advisory committee, it usually does.
SOURCE: Helio.com