The TandemHeart PTVA System by Cardiac Assist provides up to five liters per minute of blood flow through a cardiac catheterization procedure in as little as 30 minutes. The system, which recently surpassed its 850th successful procedure, is FDA cleared for extracorporeal circulatory support for up to six hours for procedures not requiring full cardiopulmonary bypass.

Cordis Corp. introduced the REGATTA Steerable Guidewire family of devices in the U.S. this week, which 12 selections of the REGATTA Steerable Guidewire and two choices of the REGATTA SB Steerable Guidewire. In April, the company plans to add the REGATTA HS Steerable Guidewire in two selections.

St. Jude Medical Inc. says it has received FDA approval of a new cardiac rhythm management device designed to help physicians manage heart failure (HF) patients, including patients who have or may develop atrial fibrillation (AF).

Rcadia Medical Imaging Ltd., an Israel-based developer of novel computer-aided diagnostic software, has received FDA clearance to market its COR Analyzer I, which assists screening of triage patients for coronary artery disease.

The FDA has granted clearance to the Cordis Endovascular division of Cordis Corp. to market its PRECISE RX Nitinol Self-Expanding Stent and ANGIOGUARD RX Emboli Capture Guidewire System to treat clogged neck arteries. The approval was announced during the Arizona Heart Institute's International Congress on Endovascular Interventions in Scottsdale, AZ.