ev3 Inc. Receives FDA Clearance for EverCross, NanoCross Peripheral Angioplasty Balloons

 

December 10, 2008

December 10, 2008 – ev3 today said it received FDA 510(k) clearance from the FDA to market its EverCross 0.035-inch and NanoCross 0.014-inch peripheral angioplasty balloon catheters.

ev3 expects to begin full commercialization of the EverCross and NanoCross peripheral balloon catheters globally in January 2009. The EverCross and NanoCross peripheral balloon catheters are designed to offer improved overall performance in peripheral angioplasty procedures, the company said. Features include beveled tip profiles for best-in-class lesion entry and a broad range of sizes, including the only 200 mm length .035-inch balloon available. The EverCross balloons also reportedly offer rated burst pressures that compete in the high-pressure balloon market without compromising ease of use.

For more information: www.ev3.net