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

Wednesday, December 10, 2008 General News
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PLYMOUTH, Minn., Dec. 9 ev3 Inc. (Nasdaq: EVVV),a global endovascular device company, announced today that it has received510(k) clearance from the U.S. Food & Drug Administration (FDA) to market itsEverCross 0.035" and NanoCross 0.014" peripheral angioplasty ballooncatheters. ev3 expects to begin full commercialization of the EverCross andNanoCross 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 thisJanuary. Based on our experience to date, we believe both balloons willenhance customer ease of use and offer significantly better margins than ourcurrent distributed product. The ability to offer our own peripheral ballooncatheter 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 tooffer improved overall performance in peripheral angioplasty procedures.Among several new features, both catheters offer innovative beveled tipprofiles for best-in-class lesion entry and a broad range of sizes, includingthe only 200 mm length .035" balloon available worldwide. The EverCrossballoons also offer Rated Burst Pressures that compete in the high pressureballoon market without compromising ease of use.

About ev3 Inc.

Since its founding in 2000, ev3 has been dedicated to developinginnovative, breakthrough and clinically proven technologies and solutions forthe treatment of peripheral vascular and neurovascular diseases. ev3'sproducts are used by endovascular specialists to treat a wide range ofperipheral vascular and neurovascular diseases and disorders. The companyoffers a comprehensive portfolio of treatment options, including the primaryinterventional technologies used today -- peripheral angioplasty balloons,stents, plaque excision systems, embolic protection devices, liquid embolics,embolization coils, thrombectomy catheters and occlusion balloons. Moreinformation about the company and its products can be found athttp://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, notpast, events are forward-looking statements under the Private SecuritiesLitigation Reform Act of 1995. Forward-looking statements often can beidentified by words such as "expect," "anticipate," "intend," "will," "may,""believe," "could," "continue," "future," "looking forward" or the negative ofthese words or other words of similar meaning. Forward-looking statements bytheir nature address matters that are, to different degrees, uncertain.Uncertainties and risks may cause ev3's actual results to be materiallydifferent than those expressed in or implied by ev3's forward-lookingstatements in this release. For ev3, such particular uncertainties and risksinclude, among others, the timing of the introduction of new products, thesuccess and market acceptance of new products, impact of competitive productsand pricing, regulatory risks, availability of third party reimbursement andev3's future operating results and financial performance. More detailedinformation on these and additional factors that could affect ev3's actualresults are described in ev3's filings with the Securities and ExchangeCommission, including its most recent annual report on Form 10-K andsubsequent quarterly reports on Form 10-Q. Except as required by law, ev3undertakes no obligation to update publicly its forward-looking statements.

SOURCE ev3 Inc.

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