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FDA Staff Has Cautious Praise for New ICD
MedPageToday, 2012WASHINGTON -- A novel subcutaneous implantable cardioverter-defibrillator has met its primary safety and effectiveness endpoints, but questions remain regarding the totality of safety and efficacy, according to FDA staff reviewers.
The agency's Medical Devices Advisory Committee will meet Thursday to discuss whether the benefits outweigh the risks for Cameron Health's subcutaneous implantable cardioverter-defibrillator (S-ICD).
The device is intended for patients with ventricular tachyarrhythmias who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing, according to the manufacturer.
pivotal trial were made public for the first time on the FDA website in anticipation of Thursday's meeting.
The prospective, nonrandomized, single-arm, multi-center (33 sites) study included only patients who needed replacement or revision of an existing implanted transvenous ICD.
Of the 314 patients in the study, the primary safety endpoint -- complication-free rate at 180 days post-implant -- was 97.9%, which was above the performance goal of 79%.
The FDA reviewers, however, noted that the primary safety endpoint only included type I complications (43 events, 37 patients), which are those caused by the S-ICD device.
The agency has concerns about other safety events: Type II complications (four events, four patients) are those caused the S-ICD System user's manual or labeling of the S-ICD system Type III (106 events, 84 patients) are not caused by the device, but would not have occurred in the absence of the implantation Type IV (45 events, 38 patients) are caused by a change in the patient's condition.
The reviewers want the FDA panel to decide whether the "totality of the safety data provides valid scientific evidence that establishes a reasonable assurance of safety of the device."
Some of these safety concerns include infections, inadequate lead position or movement requiring surgery, discomfort requiring invasive intervention, and inappropriate shocks.
A total of 28 inappropriate shocks were caused by the device oversensing, while 20 occurred because the ventricular rates were above the programmed threshold.