Covidien's SpiderFX Embolic Protection Device Approved for Use in Lower Extremities

December 1, 2011—Covidien (Mansfield, MA) announced that the US Food and Drug Administration has cleared the SpiderFX embolic protection device for use during treatment of severely calcified lesions in arteries of the lower extremities.

The company stated that the SpiderFX is now available for use in the lower extremities in the United States. Its previously approved indications are for use in carotid arteries and coronary saphenous vein grafts. Additionally, SpiderFX is approved for use in the lower extremities in most markets outside of the United States, including the European Union.

According to Covidien, the company's submission for US Food and Drug Administration approval for the lower extremity indication was supported by results from the DEFINITIVE Ca++ clinical study. The trial, which enrolled 133 patients at 17 sites, demonstrated that plaque excision using Covidien's TurboHawk device with distal embolic protection with the SpiderFX is safe and effective in patients who have severely calcified superficial femoral 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,” commented Daniel Clair, MD. “In complex cases, this technology shows promise of being a positive step forward for treating patients with peripheral arterial disease.”