Covidien’s SpiderFX embolic protection device has gained FDA approval for the treatment of severely calcified lesions in conjunction with plaque excision in the lower extremity arteries. The approval makes the SpiderFX the first embolic protection device for the above indications.
Approval was based on the DEFINITIVE CA++ study, which enrolled 133 patients from 17 clinical trial sites. The study showed that plaque excision with Covidien’s TurboHawk plaque excision system and the SpiderFX embolic protection device was safe and effective in patients with severely calcified superficial femoral artery and popliteal artery lesions.
The SpiderFX device has indications for carotid, coronary saphenous vein grafts and lower extremity use. The device has been approved in the European Union since 2005. FDA clearance will now allow Mansfield, Mass.-based Covidien to market the device in the U.S.