Boston Scientific Neurovascular

Boston Scientific markets a broad line of neuro endovascular devices including the GDC Detachable Coils, Matrix Detachable Coils, Neuroform Microdelivery Stent System, Pre-Shaped Microcatheters and the Synchro Microfabricated Nitinol Guidewires.

Boston Scientific has developed, and markets, two leading intracranial stents, the Neuroform for stent assisted coil insertions and the Wingspan for cerebral ischemia. The Food and Drug Administration (FDA), under a Humanitarian Device Exemption (HDE), approved the Neuroform Microdelivery Stent System in September 2002 and the Wingspan in August 2005.

An HDE approval is given for a device that is intended to benefit patients in the diagnosis or treatment of diseases or conditions that affect fewer than 4,000 individuals in the United States per year.

The Wingspan, a self-expanding Nitinol stent sheathed in a delivery system that enables it to reach and open narrowed arteries in the brain,  is currently the only device available in the U.S. for the treatment of intracranial atherosclerotic disease (ICAD).

The Wingspan is also marketed in Europe and selected international markets for improving cerebral artery lumen diameter in patients with ICAD who are unresponsive to medical therapy.

At the end of 2009 Boston Scientific neurovascular franchise generated an estimated US$350 million, a decline of (-3%) from a peak of $360 million in 2008. The decline was a result of new competitive launches in both the coils segment and the aneurysm stent segment.

The company plans to launch a next-generation family of detachable coils, including an enhanced delivery system with reduced coil detachment times, in the U.S. in the in the first quarter of 2010.