PLYMOUTH, Minn., June 21, 2010 (GLOBE NEWSWIRE) -- ev3 Inc. (Nasdaq:EVVV), a global endovascular device company, today announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company's Pre-Market Approval (PMA) application for the Pipeline Embolization Device for treatment of large, giant and wide-necked cerebral aneurysms. The FDA's action means that the PMA application was sufficiently complete and ready for substantive review. The filing date for regulatory purposes is May 18, 2010, the date the FDA received ev3's PMA submission. The FDA also confirmed that the PMA application will receive expedited review and processing.
"We're extremely pleased that the FDA has formally accepted the Pipeline PMA for expedited review. This brings us one step closer to realizing our goal of offering neurovascular specialists a breakthrough therapy to treat complex aneurysms," said Robert Palmisano, president and chief executive officer of ev3. "We look forward to advancing our discussions with the FDA and obtaining the agency's feedback on the Pipeline PMA and next steps in the review process."
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 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.
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," "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.