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Thoratec seeks EU nod for HeartMate II:

This article was originally published in Clinica

Executive Summary

Thoratec has filed an application in Europe to market its next generation heart assist device, HeartMate II, for long-term support. The application is based on data from the first 20 patients who were implanted with the device in the firm's phase I US trial and in a European study. These patients accounted for nearly 5,200 days of cumulative support and were each supported from 3-490 days. The Pleasanton, California firm said it hoped to CE-mark the device for sale this year. The HeartMate II is a left ventricular assist system for providing long-term cardiac support for patients who are in end-stage heart failure. It is currently being assessed in the US in a phase II trial, which is testing the product for both destination therapy and bridge-to-transplantation applications.

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