Arrow predicts Euro approval date for LionHeart:
This article was originally published in Clinica
Executive Summary
Arrow International says that it is on track to gaining European market approval in June 2002 for its fully implantable cardiac assist device. The LionHeart left ventricular assist system, which is designed to provide patients with "destination therapy", was recently implanted in two patients in Germany, bringing the total number of European implants to 25. The Reading, Pennsylvania firm is also pressing on with a phase I trial of the device in the US. Seven LionHearts have been implanted in the US and the FDA has approved an additional seven implants as a continuation of the study, the firm said.