Neurovascular delivers strong results
With eight new product launches, products in two new markets, and the acquisition of Chestnut Medical Technologies, Inc., our neurovascular segment had an exceptional year in 2009. Our neurovascular products improved their global market position as we increased penetration and expanded our presence in key markets.
Last year, we entered two new markets for ev3 with products for aneurysm repair and ischemic stroke. The Pipeline Embolization Device, which we added as a result of our acquisition of Chestnut, represents a true breakthrough in treating large, giant, and wide-neck aneurysms that present the greatest challenge to existing endovascular and surgical treatment strategies. In more than 800 clinical cases, Pipeline procedure success and complication rates have compared favorably with surgery and other endovascular procedures, including coiling, that have been used to treat complex aneurysms. We estimate a potential global market of $350 million for this device by 2013. It is already being used in Europe and other international markets, and we anticipate U.S. premarket approval in 2011.
We also introduced a new product for ischemic stroke internationally in 2009. The Solitaire™ FR Flow Restoration Device addresses a significant unmet clinical need: there are approximately 795,000 incidents of stroke in the U.S. each year and 87% of them are ischemic. The unique design of the Solitaire FR device offers the potential to improve how stroke is treated by immediately restoring blood flow, thereby saving thousands of additional lives every year. This product is currently available in Europe and other international countries, and we initiated enrollment in our U.S. SWIFT (Solitaire With Intention For Thrombectomy) Investigational Device Exemption (IDE) study in February 2010.
Moving forward, we will grow our neurovascular segment by continuing to develop and introduce breakthrough products, demonstrating the efficacy of these products in clinical trials, and leveraging our extensive global presence.
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