Embolic Protection Device for Saphenous Vein Graft Angioplasty Gets FDA Clearance
ev3, Inc. today announced the FDA 510(k) clearance of the 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 FDA clearance for use in treating SVG procedures was supported by the successful outcome of a trial involving over 700 patients that compared the safety and efficacy of the SPIDER/SpideRX Devices to three currently cleared embolic protection devices in reducing complications associated with the angioplasty or stenting of SVG lesions.
Back in February this device was approved for carotid artery stenting after a clinical trial on 160 patients.
June 26, 2006 Related topics: Product Approval & Certification