The FDA 510 (k) approval is based on the Definitive Ca++ clinical study which enrolled 133 subjects.
The study showed that SpiderFX in conjuction with the company’s TurboHawk device using distal embolic protection can be used safely and effectively in patients to treat severely calcified superficial femoral artery and popliteal artery lesions.
Covidien research consultant,Cleveland Clinic Lerner College of Medicine Surgery professor and Cleveland Clinic Vascular Surgery chairman Daniel Clair said in complex cases, this technology shows promise of being a positive step forward for treating patients with peripheral arterial disease.
