Cordis Empira PTCA Catheters get 510(k) approval for Coronary Artery Disease

Cordis Corporation has announced EMPIRA™ and EMPIRA™ NC RX PTCA Dilatation Catheters have received 510(k) regulatory clearance for the treatment of coronary artery disease. The EMPIRA™ Balloon Catheters are used in angioplasty procedures and are designed to enable interventional cardiologists to open patients’ narrowed coronary arteries.

The family of EMPIRA™ Balloon Catheters incorporates several design and technology changes that have the potential to improve crossability and recrossability, while enhancing the controlled growth characteristics of the balloon material. The semi-compliant EMPIRA™ RX PTCA Pre-Dilatation Catheter and the non-compliant EMPIRA™ NC RX PTCA Post-Dilatation Catheter utilize the next generation DURALYN® Flex balloon material, which is 50% more flexible than the DURALYN® balloon material used in the current FIRE STAR® and DURA STAR® RX PTCA Dilatation Catheters.1 These new products will become available in the USA in 2012.

“The EMPIRA™ Balloon Catheters offer our most advanced technology designed to treat challenging coronary artery disease,” said Campbell Rogers, MD, Cordis Chief Scientific Officer, Global Head R&D. “Cordis worked closely with our physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the EMPIRA™ Balloon Catheters will meet physicians’ needs and has the potential to improve patient outcomes. These products further expand the array of high quality tools we offer physicians to treat patients with coronary artery disease.”

1 Cordis Corporation. Data on file, 2011.

Source: Cordis