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.