FDA approves St. Jude’s safety-enhanced devices

The FDA approved next-generation implantable defibrillators that offer new safety and performance features.

Minneapolis-based St. Jude Medical announced its Ellipse and SJM Assura family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) include an algorithm that ensures therapy is delivered in the event of an electrical short and a low-friction coating on the device that can reduce friction between the device and leads.

A past analysis of some Durata leads had found abrasions and abrasions that resulted in high-voltage failures. St. Jude recalled its Riata and Riata ST silicone leads in late 2011 due to insulation failures.

The Ellipse and Assura portfolio of ICDs and CRT-Ds received CE mark in Europe in May.