Boston Scientific in Natick has won clearance from the U.S. Food and Drug Administration to expand its PolarCath Peripheral Dilation System offering to include a 100-millimeter balloon, allowing for treatment of longer blockages in the arteries.
Used in patients facing the risk of limb amputation, the PolarCath system is a form of balloon angioplasty that cools the inside of occuluded arteries in the legs while opening arterial blockages. The longer balloon length will allow interventionalists to address a wider range of blockages, said John Pedersen, president of Boston Scientific’s Peripheral Interventions business.
The new balloon is available in both 0.014-inch and 0.035-inch diameters. The PolarCath system also comes in balloon lengths of 20, 40, 60, and 80 millimeters.
Boston Scientific is a manufacturer of medical devices.