ev3, a global endovascular device company, has filed the final module of its premarket approval (PMA) application with the FDA for the Pipeline Embolization Device. The 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 45 day filing process as the first step in the formal review of the PMA. ev3 anticipates the FDA could schedule an advisory panel review sometime later in the year.
The PUFS (Pipeline for Uncoilable or Failed AneurysmS) study enrolled and treated 108 patients at 10 centers in the US 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.
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.
Robert Palmisano, president and CEO of ev3, said: “This PMA submission is an important milestone for ev3 and our commitment to advance innovative technologies to treat neurovascular disease. We are very encouraged by the positive clinical results seen to date outside the US 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.”
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 $350m in 2013.