ev3 Inc., a global endovascular device company, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its EverCross 0.035 and NanoCross 0.014 peripheral angioplasty balloon catheters. ev3 expects to begin full commercialization of the EverCross and NanoCross peripheral balloon catheters globally in January 2009.
ev3 Inc., a global endovascular device company, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its EverCross 0.035 and NanoCross 0.014 peripheral angioplasty balloon catheters. ev3 expects to begin full commercialization of the EverCross and NanoCross peripheral balloon catheters globally in January 2009.
Robert Palmisano, ev3's president and chief executive officer commented, We are looking forward to launching the EverCross and NanoCross balloons this January. Based on our experience to date, we believe both balloons will enhance customer ease of use and offer significantly better margins than our current distributed product.
The EverCross and NanoCross peripheral balloon catheters are designed to offer improved overall performance in peripheral angioplasty procedures. Among several new features, both catheters offer innovative beveled tip profiles for best-in-class lesion entry and a broad range of sizes, including the only 200 mm length .035" balloon available worldwide.