CryoPlasty

CryoPlasty™ Therapy is a unique non-surgical therapy designed to improve the blood circulation in an artery while simultaneously treating it to inhibit restenosis. 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.

HEALTH CARE PROFESSIONALS

Overview

PATIENTS

Healthcare Professionals

CryoPlasty™ Therapy is a form of angioplasty. CryoPlasty Therapy simultaneously dilates and treats atherosclerotic plaque. A balloon 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.

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 are intended to enhance the visibility of the balloon under fluoroscopy during the procedure.

BTK CHILL Data Results: 180-Day Outcomes have shown CryoPlasty™ Therapy is an excellent option for treatment Below The Knee. The Below-The-Knee (BTK) CHILL study, a prospective, multi-center trial with 111 patients at 16 sites in the United States, evaluated the PolarCath™ Peripheral Dilatation System for patients with critical limb ischemia (severe blockages in the arteries below the knee).

The results demonstrated:

Acute technical success of 97%
Freedom from amputation of 93% at 180 days
Durability of CryoPlasty Therapy may yield improved health and quality of life

*PEBAX is a trademark of Arkema France Corporation.

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