Covidien has received FDA approval for its SpiderFX embolic protection device for the treatment of severely calcified lesions that’s used in conjunction with plaque excision in arteries of the lower extremities. It captures and removes debris that becomes dislodged during interventional procedures that may otherwise flow downstream and block smaller vessels.
The device itself is not new and has been on the market since 2005, but it is the first such device to be approved in the U.S. for use in the lower extremities.
From the press release:
Embolic protection devices are used to capture and remove debris that becomes dislodged during an interventional procedure. Embolic debris may block smaller vessels, resulting in procedural complications or poor patient outcomes. While the risk of complications associated with embolic debris exists during all types of interventional procedures, patients with complex conditions such as critical limb ischemia, single vessel runoff or complex lesions (such as calcium or thrombus) face even greater risk.
Covidien submitted the 510(k) to the FDA seeking clearance for use of the SpiderFX embolic protection device in lower extremity endovascular procedures, based on results from the DEFINITIVE™ Ca++ clinical study. DEFINITIVE Ca++ enrolled 133 subjects from 17 investigational clinical sites. It demonstrated that plaque excision with Covidien’s TurboHawk™ device utilizing distal embolic protection with the SpiderFX can be used safely and effectively in patients who have severely calcified superficial femoral artery and popliteal artery lesions, including those with single vessel runoff.
SpiderFX has the broadest indication among distal embolic filters in the U.S. with indications for carotid, coronary saphenous vein graft, and lower extremity use. SpiderFX is already indicated for use in the lower extremities in most geographies outside of the U.S. and has been sold in Europe since 2005. Following this FDA clearance, SpiderFX is now available for use in the lower extremities in the U.S.
Press release: Covidien’s Embolic Protection Device Receives FDA Clearance…
Product page: SpiderFX Embolic Protection Device…