ev3 wins FDA approval for SpideRX embolic protection device

New York, June 26 - ev3, Inc. said it was given 510(k) clearance by the Food and Drug Administration for its SpideRX embolic protection device to contain and remove embolic debris during treatment of coronary artery saphenous vein bypass graft lesions with PTCA and/or stent placement.

The SpideRX is the only embolic protection device cleared by the FDA for use during the endovascular treatment of both saphenous vein graft and carotid artery lesions, ev3 said.

The Plymouth, Minn., medical device company said it will release the product immediately for commercial sale under this additional indication.

"Now that the FDA has cleared the SpideRX embolic protection device in saphenous vein grafts, it will quickly become the dominant distal protection device in the U.S. market," said William O'Neill of William Beaumont Hospital, national principal investigator for the Spider saphenous vein graft trial, in a company news release.

"The RX capability allows for single operator use and allows the operator to use a separate preferred guidewire to initially cross the lesion, making this device highly desirable to the physician."

Saphenous vein grafts are commonly used during open-heart surgery to bypass blocked arteries. As many as one-third of patients experience significant blockages in the grafted vessel or vessels within 12 years following surgery and, as a result, may be treated with an endovascular procedure including either balloon angioplasty or stenting. These procedures often dislodge small particles called emboli that can block small down stream arteries and possibly damage heart muscle and cause a heart attack. The SpideRX Device has a nitinol mesh filter to capture embolic debris.

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