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Sorin's Isoline defibrillation leads

This article was originally published in Clinica

Executive Summary

The Isoline range of steroid-eluting defibrillation leads developed by ELA Medical has received a premarket approval (PMA) from the US FDA. The approval covers the Isoline 2CR5 and 2CR6 active fixation models and the Isoline 2CT5 and 2CT6 passive fixation models. The Isoline leads have a multi-lumen structure, composed of a large number of individual conductor wires, each with a silver core, covered with the fluoropolymer ETFE and a double layer of silicone insulation. They also have a polyurethane overlay to provide better abrasion resistance. The leads were successfully launched in Europe two years ago. Denver, Colorado-based ELA is a subsidiary of Sorin.

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