Boston Scientific wins approval for dilation system expansion
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.
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