ev3, Inc. (EVVV) has recently filed the final module of its Pre-market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its Pipeline Embolization Device. The company expects the FDA to schedule an advisory panel review of the proposal in late 2010 and the product approval in 2011.
The Pipeline Embolization Device is used for treating large, giant and wide-neck aneurysms. The PUFS (Pipeline for Uncoilable or Failed AneurysmS) was a single-arm study of large and giant, wide-neck or fusiform aneurysms that are typically not coilable. The study enrolled and treated 108 patients at 10 centers in the U.S. and Europe. Results were positive with safety and effectiveness endpoints being achieved.
The Pipeline Embolization Device is an alternative to present endovascular or surgical treatment options available in the market for treating aneurysms. We think that the new product approval will significantly boost ev3’s top-line. The company estimates the worldwide market for aneurysm treatment at roughly $350 million by 2013.

ev3 is a Plymouth, MN-based endovascular company that concentrates on catheter-based or endovascular technologies for the minimally invasive treatment of vascular diseases and disorders. The company’s acquired broad product portfolio focuses on applications in each of the three sub-markets of the endovascular device market (ev3) − peripheral vascular, cardiovascular and neurovascular. ev3 competes in the endovascular market with a number of large companies like Boston Scientific Corp. (BSX), Medtronic Inc. (MDT), C.R. Bard (BCR), Cordis, etc. Presently, we are ‘Neutral’ on ev3.
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