Covidien has announced that the U.S. Food and Drug Administration (FDA) has expanded the scope of approval for its SpiderFX® embolic protection device to include 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 and this approval follows some 6 years behind the product’s gaining CE mark approval for this indication in Europe.
SpiderFX now has the broadest indication among distal embolic filters in the U.S. with indications for carotid, coronary saphenous vein graft, and lower extremity use.The device 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.”
What took so long?
Covidien submitted the 510(k) to the FDA based on results from the DEFINITIVE™ Ca++ clinical study, in which were 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.
Covidien’s press release can be read here