FDA Panel Backs New ICD
-- An FDA advisory committee has voted 7-1 to recommend approval for a novel subcutaneous implantable cardioverter defibrillator (ICD).
The agency's Circulatory System Devices Advisory Committee voted Thursday that the benefits outweigh the risks for Cameron Health's subcutaneous ICD (S-ICD).
The panel agreed that patients who are at risk of their heart stopping could benefit from an ICD that doesn't require a transvenous lead, which is the number one cause of complications in ICDs.
Unlike traditional ICDs which require a lead wire to be threaded through a vein to the heart, the subcutaneous ICD delivers electricity to defibrillate the heart through an electrode under the skin.
That design feature may make the device a good option, especially for patients who are prone to infections or who have congenital heart disease, according to several panelists.
"I think this is something we've all been waiting for for a very long time," said panelist Pamela Karasik, MD, a cardiologist and cardiac electrophysiologist at the Veteran's Administration Hospital in Washington, D.C.
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.
The committee based its vote on Cameron Health's prospective, nonrandomized, single-arm, multicenter study that included only patients who needed replacement or revision of an existing implanted transvenous ICD.
The primary efficacy endpoint -- successful conversion of induced ventricular fibrillation -- was met in 98.8% of those who were tested, which exceeded the performance goal of 88%.
The primary safety endpoint -- complication-free rate at 180 days post implant -- was achieved by 97.9% of the 314 patients in the trial, which was above the performance goal of 79%.
A total of 28 inappropriate shocks were caused by the device oversensing, while 20 occurred because the ventricular rates were above the programmed threshold.