PolarCath® Peripheral Dilatation System

Product Information

The PolarCath Peripheral Dilatation System delivers cryo therapy and is designed to initiate both mechanical and biological responses in order to produce beneficial vascular effects. CryoPlasty Therapy, through the use of the PolarCath Peripheral Dilatation System, combines a unique application of cold therapy with angioplasty for the results you want now and the benefits you may need later.

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.

Device Illustration

1. Overall Usable Length
2. Balloon Working Length
3. Inflated O.D.
4. PEBAX® Material Dual Balloon

Additional Information

• Low-crossing profile
• Treatment cycle less than one minute
• Multiple inflations to treat long lesions
• Radiopaque markings for accurate placement
• Automated user interface
• Single-use disposable components

Design: Dual Balloon, Nitrous Oxide Expanded, Microprocessor Controlled

Balloon Material: PEBAX^® Polyether-block-amide

Balloon Diameters:
0.035" – 4 thru 8mm
0.014" – 2.0mm, 2.5mm, 3mm, 3.5mm, 4mm, 5 mm, 6 mm

Balloon Lengths:
0.035" – 20, 40, 60, 80 & 100mm
0.014" – 20, 40, 60 & 100mm

Catheter Lengths:
0.035" – 80cm & 120cm
0.014" – 135cm & 150cm
Non-Expanded Profile:
0.035" – 0.078" (7F)
0.014" – 0.055" (5.8F)

Sheath Compatibility
0.035" -- 4mm and 5mm - 6F
              6mm and 7mm - 7F
              8mm - 8F
0.014" -- 2mm thru 4mm - 5F
              5mm & 6mm - 6F

PEBAX is a trademark of Arkema France Corporation.

*Complete data sets available from Boston Scientific upon request