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ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons
Date:12/9/2008

PLYMOUTH, Minn., Dec. 9 /PRNewswire-FirstCall/ -- ev3 Inc. (Nasdaq: EVVV), a global endovascular device company, announced today 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 ability to offer our own peripheral balloon catheter also provides access to key international markets, including Europe, where we do not currently sell balloons."

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. The EverCross balloons also offer Rated Burst Pressures that compete in the high pressure balloon market without compromising ease of use.

About ev3 Inc.

Since its founding in 2000, ev3 has been dedicated to developing innovative, breakthrough and clinically proven technologies and solutions for the treatment of peripheral vascular and neurovascular diseases. ev3's products are used by endovascular specialists to treat a wide range of peripheral vascular and neurovascular diseases and disorders. The company offers a compr
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