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08-10-2012 | Article

Subcutaneous ICD gets FDA nod

Abstract

FDA medical devices website

medwireNews: The Food and Drug Administration (FDA) has granted approval to the first implantable cardioverter-defibrillator (ICD) with subcutaneous rather than transvenous leads.

The subcutaneous ICD (S-ICD, Cameron Health, San Clemente, California) was shown in a prospective, non-randomized clinical study to meet a primary effectiveness endpoint of successful ventricular fibrillation, defined as two consecutive successful conversions out of a possible four attempts in the same shock polarity, in all of 304 evaluable patients.

The rate of major complications related to implantation of the S-ICD was 4.4% at 30 days and 7.9% at 180 days.

"The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal. Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device," said Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health, in a statement.

The device consists of a pulse generator that is implanted into the left lateral, middle axillary line with a lead that is tunneled across to a subxiphoid incision, then carried along the left parasternum to the sternal angle, at the second intercostal space.

The lead has two electrodes: one that sits at the angle, and the other situated by the xiphoid process. A coil between the electrodes carries the electrical shock vector across the heart to the casing of the generator.

The subcutaneous design allows the device to be implanted without venous or cardiac access and without the need for fluoroscopy. The S-ICD is approved for defibrillation in patients with ventricular arrhythmias who do not require a pacemaker or pacing therapy.

Registration trial data submitted with the application for approval showed that the S-ICD was successful at converting all investigator-induced arrhythmias back to normal, and successfully detected and recorded 78 spontaneous arrhythmias in 21 patients in the 6 months following implantation. All of the arrhythmias were either successfully converted or resolved without treatment.

As a condition for approval, the FDA is requiring the medical device developer Cameron Health Inc to evaluate the safety and efficacy of the device in 1618 patients who will be followed up for 5 years.

By Neil Osterweil, medwireNews reporter