Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has cleared SpiderFX® for the treatment of severely calcified lesions used in conjunction with plaque excision in arteries of the lower extremities. It is the only embolic protection device indicated for this treatment in the United States.
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.
"The expanded indication of these devices offers interventionalists a safer option for dealing with severely calcified lesions. In complex cases, this technology shows promise of being a positive step forward for treating patients with peripheral arterial disease," said Daniel Clair, M.D., Chairman of the Department of Vascular Surgery at the Cleveland Clinic and Professor of Surgery, Cleveland Clinic Lerner College of Medicine. Dr. Clair does research consulting work with Covidien.
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.
"Certain high-risk situations necessitate use of an embolic protection device because an embolic event is more likely to occur," said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. "Our goal is to educate physicians about the importance of using an embolic protection device during high-risk situations, such as severely calcified lesions."
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