ev3 files final module of PMA for Pipeline Embolization Device

ev3 Inc. (Nasdaq:EVVV), 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™ 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.