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.
The novel form of balloon angioplasty that utilizes the PolarCath System — called CryoPlasty — is a less invasive was to prevent amputation in patients with severe peripheral artery disease, according to John Pedersen, president of Boston Scientific's Peripheral Interventions business.
Cryoplasty cools the inside of occluded arteries in the legs while opening the blockages; nitrous oxide is used to fill an angioplasty balloon within a blocked artery, cooling the balloon's surface to -10 degrees C. Boston Scientific reports that as the balloon is inflated, the cold surface of the balloon cools the vascular lesion, which may help prevent re-blockage of the artery. Efficacy of the therapy using the PolarCath Peripheral Dilatation System was demonstrated in the Below-The-Knee (BTK) CHILL trial.
The procedures are usually performed within a few hours and can provide significant pain relief. Pederson says that the availability of the longer balloon length will enable interventionalists to address a wider range of the debilitating blockages more efficiently, including longer lesions in the subfemoral arteries.
For more information visit www.bostonscientific.com..