Jan. 31, 2007 — Boston Scientific Corp. days it has received FDA 510(k) clearance to expand its PolarCath Peripheral Dilatation System offering to include a 100-mm balloon. The system is used to restore blood flow and reduce the risk of amputation in patients with critical limb ischemia (severe blockages in the arteries below the knee), or femoropopliteal blockage, a result of peripheral artery disease.
The new, 100-mm balloon is available in both 0.014-inch and 0.035-inch diameters. The PolarCath System also offers balloon lengths of 20, 40, 60 and 80 mm.
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