FDA Approval And US Launch Of Sorin’s Portfolio Of Implantable Heart Device Leads

In short

Sorin Group has used Heart Rhythm 2012 as the vehicle at which to announce FDA clearance and US commercial launch for a full portfolio of pacing, defibrillation and left ventricular leads. The range received CE marking back in February as we covered here.

Background

Sorin says its three lead series – TILDA pacing leads, VIGILA defibrillation leads and CELERITY left ventricular leads – are designed for effective electrical performance and durability. Each of the three lead series include multiple sizes and features to enable physicians to match their implant preferences with individual patient needs.

In addition to a flexible silicone lead body, steroid eluting tips that reduce inflammation, and iridium fractal coated electrodes with claimed proven electrical performance, each lead family offers its own additional features:

TILDA pacing leads include a flexible lead body and distal tip and are designed for easy implantation and predictable performance.

VIGILA defibrillation leads feature a symmetrical lead body and thick outer insulation. Convex shock coils embedded in silicone insulation are engineered to minimize tissue in-growth.

CELERITY left ventricular leads have a flexible co-radial body, and are designed to facilitate access and ensure stability in targeted pacing sites regardless of patients’ coronary venous anatomies.

Company comments

“Sorin Group is bringing important new implantable heart rhythm and heart failure systems to the United States, an important and growing market for Sorin Group. The VIGILA, TILDA and CELERITY leads are important additions that will help the U.S. physicians manage their patients,” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit. “We’ve received tremendous feedback from physicians in other international markets about the reliability of these leads, and we are committed to continuing to deliver outstanding technologies to enhance clinical performance and patient outcomes in the United States and throughout the world.”

Source: Sorin Group