FDA Approves Sorin's New Defibrillation Leads
March 11, 2008 - Sorin Group's ELA Medical received the FDA’s approval to market ISOLINE, a new defibrillation lead designed with redundant insulation and abrasion resistant materials for longevity and safety, in a move that strengthens the company’s position in the U.S. market.
The leads have a multilumen structure with a silicone body and include an ETFE protective coating placed around the cables leading to the electrodes. This redundant insulation is also made by a third layer of protection consisting of a polyurethane overlay to provide better abrasion resistance. Both ends of the defibrillator electrodes are securely connected to the cables.
Abrasion resistance materials such as polyurethane are said to have much better friction coefficients than other materials such as silicone, according to the manufacturer. Avoiding lead abrasion is very important to maximize leads longevity and protect patients’ safety.
ISOLINE leads are steroid eluting, dual coil defibrillation leads available in active and passive fixation models. A clinical trial showed that with a fully isodiametric 7.8 F lead body, ISOLINE ensures very good manoeuvrability and overall handling characteristics. ISOLINE leads also offer EASYTURN: a lead placement system for positioning the lead and extending the helix with a single stylet. It also features Easy Mapping to obtain pacing thresholds without helix extension.
For more information: www.sorin.com