Healthcare Industry News:  Balloon catheter 

Devices Interventional FDA

 News Release - December 9, 2008

ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons

PLYMOUTH, Minn., Dec. 9 (Healthcare Sales & Marketing Network) -- 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 comprehensive portfolio of treatment options, including the primary interventional technologies used today -- peripheral angioplasty balloons, stents, plaque excision systems, embolic protection devices, liquid embolics, embolization coils, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at http://www.ev3.net.

ev3, the ev3 logo, EverCross and NanoCross are trademarks of ev3 Inc., registered in the U.S. and other countries.

Forward-Looking Statements

Statements contained in this press release that relate to future, not past, events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as "expect," "anticipate," "intend," "will," "may," "believe," "could," "continue," "future," "looking forward" or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause ev3's actual results to be materially different than those expressed in or implied by ev3's forward-looking statements in this release. For ev3, such particular uncertainties and risks include, among others, the timing of the introduction of new products, the success and market acceptance of new products, impact of competitive products and pricing, regulatory risks, availability of third party reimbursement and ev3's future operating results and financial performance. More detailed information on these and additional factors that could affect ev3's actual results are described in ev3's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Except as required by law, ev3 undertakes no obligation to update publicly its forward-looking statements.



Source: ev3

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