CoreValve predicts 2007 EU approval for percutaneous heart valve technology
This article was originally published in Clinica
Executive Summary
French firm CoreValve believes it could be set to gain European market approval next year for its percutaneous heart valve replacement technology, the ReValving system. The company recently began a 100-patient clinical trial of a third-generation version of the product, which comprises a delivery catheter component that has been reduced in size to 18F. The first-generation system featured a 25F catheter, which is "very sizeable" by interventional standards, explained the Paris-based firm. As well as the delivery catheter, CoreValve's product consists of a porcine pericardium valve that is mounted on a self-expanding stent. The device is delivered using standard "cath lab" techniques.