Healthcare Professionals
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.
The PolarCath Peripheral Dilatation System has demonstrated excellent clinical results:
IDE Study Results*
Treatment Outcomes:
- 94% acute angiographic success
- 7% flow-limiting dissection rate
- 9% concomitant stent rate
Patency Outcomes:
- 17.8% target lesion revascularization rate
- 70% primary patency
- 82% clinical patency
- 80% of treated patients experienced ABI improvement
- 89% of treated patients experienced claudication improvement
- Extended Follow-up — Up to 3.4 years
- 75% freedom from TLR
Below-the-Knee Chill Study Results*
180 Day Outcomes Below-the-Knee Chill Study:
97% Acute technical success (N = 111)
- 2% >50% residual stenosis
- 1% Clinically significant dissections (due to guide wire Investigator Report)
- 6% Non-clinically significant dissections (Type A or B)
93% 180-day freedom from major amputation (N = 91)*
85% 365-day freedom from major amputation (N = 78)*
*N = total limbs reported.
*Complete data sets available from Boston Scientific upon request
