PLYMOUTH, Minn., May 18, 2010 (GLOBE NEWSWIRE) -- ev3 Inc., a global endovascular device company, today announced that it has filed the final module of its Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Pipeline(TM) Embolization Device. This final module, containing a comprehensive review of the clinical data, completes the PMA application to the FDA. Upon receipt of the clinical module, the FDA begins its 45 day filing process as the first step in the formal review of the PMA. The company anticipates the FDA could schedule an advisory panel review sometime later in the year.
"This PMA submission is an important milestone for ev3 and our commitment to advance innovative technologies to treat neurovascular disease," said Robert Palmisano, president and chief executive officer of ev3. "We are very encouraged by the positive clinical results seen to date outside the United States for the Pipeline device in treating large, giant and wide-neck aneurysms and look forward to working with the FDA to facilitate the review and approval of this breakthrough endovascular treatment, which we anticipate in 2011."
The PUFS (Pipeline for Uncoilable or Failed AneurysmS) study enrolled and treated 108 patients at 10 centers in the U.S. and Europe. PUFS is a single-arm study of large and giant, wide-neck or fusiform aneurysms typically not coilable, with a six-month safety and effectiveness endpoints.
Safe and effective treatment of large and giant, wide-neck or non-saccular aneurysms remains a significant unmet clinical need. Clinical experience suggests that the Pipeline Embolization Device may represent a valuable alternative to current endovascular or surgical treatment options for these types of aneurysms. ev3 estimates that approximately one fourth of worldwide aneurysm treatment procedures could be eligible for treatment with flow diversion devices over the next five years, translating into a market potential of approximately $350 million in 2013.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing breakthrough and clinically proven technologies for the endovascular treatment of peripheral vascular and neurovascular diseases. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today -- plaque excision systems, peripheral angioplasty balloons, stents, embolic protection devices, liquid embolics, embolization coils, flow diversion, 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 and Pipeline are trademarks of ev3 Inc. and its subsidiaries, registered in the U.S. and other countries.
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," "estimate," "outlook," "guidance," or the negative of these words, other words of similar meaning or the use of future dates. Forward-looking statements in this press release include the date we anticipate FDA approval of the Pipeline Embolization Device and the estimated market potential for the Pipeline Embolization Device. 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. For ev3, particular uncertainties and risks include, among others, the timing of regulatory approvals and introduction of new products, market acceptance of new products, success of clinical testing, availability of third party reimbursement, impact of competitive products and pricing, the effect of regulatory actions and the cost and effect of changes in tax and other legislation. 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. Except as required by law, ev3 undertakes no obligation to publicly update its forward-looking statements.
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