The CryoPlasty® Procedure

CryoPlasty Therapy is a unique non-surgical therapy designed to improve the blood circulation in an artery by combining the application of cold therapy with angioplasty. Left untreated, peripheral arterial disease (PAD) may result in leg sores that will not heal (ulcers), infection, gangrene, amputation of toes, feet or legs, or even death. PAD is a strong risk factor for a major event such as a heart attack or stroke.

CryoPlasty Therapy combines a unique application of cold therapy with angioplasty. Boston Scientific's CryoPlasty Therapy device - PolarCath® Peripheral Dilatation System, a balloon catheter - is a coaxial, dual balloon design and is made of PEBAX® Material. Gas is contained in the inner balloon. Radiopaque markings enhance the visibility of the balloon under fluoroscopy during the procedure. The PolarCath Peripheral Dilatation System is delivered to the lesion and is inflated with nitrous oxide gas. The vessel wall is cooled with a 20-second treatment at -10°C.

Apoptosis is a Key Mechanism of Action of Cryo Therapy

Apoptosis is a non-inflammatory process found in human vascular pathology of proliferative restenotic lesions.¹ In vitro studies have demonstrated that application of cryo therapy can modulate the neointimal response that leads to restenosis through induction of smooth muscle cell apoptosis.²

A pre-clinical study has shown that a substantial fraction of smooth muscle cells undergo apoptosis, while minimizing necrosis, in response to temperatures in the range of -5°C to -15°C.²

References:
¹ Isner JM, Kearney M, Bortman S, et al. Apoptosis in human atherosclerosis and restenosis. Circulation. 1995;91(11):2703-2711.
² Tatsutani KN, Joye JD, Virmani R, et al. In vitro evaluation of vascular endothelial and smooth muscle cell survival and apoptosis in response to hypothermia and freezing. CryoLetters. 2005;26(1):55-64.