FlowCardia Receives EU Approval, Completes Clinical Trial

FlowCardia, a developer of catheter-based systems to treat chronic total occlusions (CTOs) of coronary and peripheral arteries, has announced that the company's application for CE Marking of the CROSSER catheter has been approved for use in coronary arteries following failure to cross CTOs with conventional guidewire techniques.

FlowCardia's CROSSER System utilizes high-frequency mechanical vibration to safely and quickly cross CTOs allowing subsequent balloon angioplasty and/or stent placement and obviating the need for potentially traumatic cardiac surgery.

Also, FlowCardia received approval from the FDA in December 2004 to start the pivotal phase of the U.S. clinical trial for its CROSSER System. The first patients in the pivotal study have already been enrolled, and it is expected that the trial will be completed and a request for 510(k) clearance from the FDA will be submitted in the second half of 2005.