ev3 Inc. Receives FDA Clearance For SpideRX(TM) Embolic Protection Device For Saphenous Vein Graft Angioplasty
PLYMOUTH, Minn., June 26 /PRNewswire-FirstCall/ -- 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 SpideRX is now the only embolic protection device that is FDA cleared for use during the endovascular treatment of both saphenous vein graft ("SVG") and carotid artery lesions. The company will release the product immediately for commercial sale under this additional indication.
Dr. William O'Neill of William Beaumont Hospital, National Principal Investigator for the SPIDER SVG Trial stated, "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. 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."
The SPIDER/SpideRX product family is one of the most broadly tested of commercially available embolic protection devices. 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. The SpideRX clearance for use in carotid artery stenting earlier this year was supported by a 160-subject clinical trial. The results of a third clinical trial utilizing the SPIDER/SpideRX family and the ProtÃ©gÃ© stent for the treatment of carotid artery disease in 419 subjects has been submitted to the FDA. In total, the SPIDER/SpideRX Devices were evaluated in over 1,100 clinical trial patients.
SVGs 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(s) within 12 years following CABG surgery and, as a result, may be treated with an endovascular procedure including either balloon angioplasty or stenting. These procedures often dislodge small particles ("emboli") that can block small down stream arteries and possibly damage heart muscle and cause a heart attack.
The SpideRX Device features a unique nitinol mesh filter to capture embolic debris. The device is designed to provide efficient delivery, capture and recovery while allowing the endovascular specialist to use a separate, preferred guidewire to cross the lesion. The device features a complete rapid exchange catheter system, 6 Fr. Guide catheter compatibility and a unique dual-end delivery/recovery catheter. The Capture Wire can also be used with both rapid exchange and over-the-wire interventional PTCA and stent devices.
Jim Corbett, CEO, ev3 stated, "Clearance and commercialization of the SpideRX Device for use in saphenous vein grafts, added to our existing cleared indication for use during carotid artery stenting procedures, is an important milestone as it further documents the versatility and breadth of applications of this proprietary technology platform."
The SpideRX Device is currently commercially available in Europe and numerous Asian and Latin American markets under a General Vascular indication that covers utilization in saphenous vein grafts, carotid and coronary arteries, and peripheral arteries and veins.
ev3 Inc. is a global medical device company focused on endovascular technologies for the minimally invasive treatment of vascular diseases and disorders.
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited, to, in no particular order: product demand and market acceptance, the impact of competitive products and pricing, and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc.'s operating and financial results are described in the company's filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. ev3 Inc. urges all interested parties to read these reports to gain a better understanding of the many business and other risks that the company faces. Additionally, ev3 Inc. undertakes no obligation to publicly release the results of any revision to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.
ev3, the ev3 logo and SPIDER/SpideRX are trademarks of ev3 Inc., registered in the U.S. and other countries.
Guardwire is a registered trademark of Medtronic, Inc.
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