Boston Scientific stent system gains limited approval[ ... Read the full article ... ]
Boston Business Journal
11:16 AM EDT Tuesday
Boston Scientific Corp. has gotten limited regulatory approval for a stent system to treat a stroke.
The Natick, Mass. company (Nasdaq: BSX) announced Tuesday that it had gained a humanitarian device exemption approval from the U.S. Food and Drug Administration for its new Wingspan Stent System and catheter.
The device is designed to treat accumulated plaque in brain arteries and potentially prevent what is known as an ischemic stroke, which is caused by a blocked blood vessel that can deprive the brain of oxygen. Wingspan removes plaque build-up that can block the blood. Approval is based on a 45-patient study conducted at 12 sites in Europe and Asia.
Anthony H. Risser | neuroscience | neuropsychology | brain