Clinical Data

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Clinical Data

Existing Key Clinical Trials - Above the Knee (ATK) & Below the Knee (BTK)

IDE (2005) (View Study)

Multi-Center Registry, 108 patients
Procedural Success: 94%
Primary Patency at 9 months

70.1% with PSVR of 2.0
81% with PSVR of 2.5 (current standard)

Clinical Patency: 82.6%

IDE Follow-up (2006) (View Study)

Clinical patency by Kaplan- Meier

83.2% after 300 days
75.0% after > 3 years

BTK Chill Study (2009) (View Study)

Prospective, Multi-center, 100 patients
365 Day Freedom from Amputation: 85%

Acute Technical Success: 97%
Rutherford Class 4: 95.5 %
Rutherford Class 5: 98.0%
Rutherford Class 6: 96.4%

Clinically significant dissections: 1%

PSVR (Peak Systolic Velocity Ratio)

COBRA Trial (2012) - PolarCath vs PTA for Post dilatation of Nitinol Stents (View Study)

Prospective, Multi-center, Randomized controlled clinical trial of diabetic patients with complex disease
Cryoplasty significantly reduced, by nearly 50%, the 12 month restenosis rate compared to PTA

Primary endpoint: binary restenosis

Cryoplasty: 29.3%
PTA: 55.8%

SFA CTO binary restenosis
Cryoplasty: 36.0%
PTA: 70.0%