ev3 Inc. Announces US FDA Approval Of PROTEGE RX Carotid Stent
Plymouth, MN - ev3 Inc. recently announced U.S. Food and Drug Administration approval of the PROTEGE RX Carotid Stent. This stent, when used in conjunction with the ev3 embolic protection device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. ev3's SpideRX Embolic Protection Device was previously FDA cleared for carotid use in February 2006.
The FDA approval was supported by the CREATE (Carotid Revascularization with ev3, Inc. Arterial Technology Evolution) Trial demonstrating the safety and effectiveness of the PROTEGE Stent and the SPIDER Embolic Protection Device when used together to treat carotid artery disease patients at risk for stroke and also at high-risk for adverse events from surgery. The CREATE Trial enrolled 419 patients in 31 centers in a prospective, non-randomized study. The results of the CREATE trial compared favorably with performance criteria that were based on the results of previous carotid stenting trials.
The PROTEGE RX is available in both straight and tapered stent configurations providing a variety of device options to address a broad range of patient anatomy present in carotid artery disease. The "rapid exchange" platform allows for a single physician to operate the device as compared to "over the wire" designs that require multiple operators. The SpideRX Embolic Protection Device is the only available distal filter embolic protection device that permits physicians to use their guidewire of choice and is cleared by the FDA for use in both carotid arteries and saphenous vein grafts.
Gary Ansel, M.D., Riverside Hospital, Columbus, Ohio, national co-principal investigator for the CREATE Trial, stated, "The ev3 products used in treating carotid disease offer unique features that make these products ideally suited for carotid artery stenting. The PROTEGE RX Carotid Stent has an innovative delivery system that allows physicians to place the stent accurately and also provides great visible confirmation due to its distinct radiopaque markers. The SpideRX Embolic Protection Device is unique because it allows physicians to use any guidewire they choose to cross the lesion just as they would in any other endovascular intervention."
Robert Safian, M.D., William Beaumont Hospital, Royal Oak, Mich., national co-principal investigator for the CREATE Trial, stated, "The results of the CREATE Trial were comparable to other high-risk carotid registries and provide additional evidence of the efficacy and safety of carotid stenting to prevent stroke."
Carotid arteries, located on either side of the neck, are the main blood vessels providing blood flow to the brain. When carotid arteries are narrowed by atherosclerotic disease, patients are at risk for ischemic stroke (a blockage of an artery in the brain by embolic particles). Stroke is the third leading cause of death in the United States, affecting nearly 700,000 Americans each year, with approximately 30 percent of strokes being caused by embolic debris that originates in diseased carotid arteries. Traditionally, carotid artery disease has been treated with an open surgery called endarterectomy. However, for the many patients who are at high risk for surgery, carotid stenting has evolved as a viable option.
Jim Corbett, ev3's president and CEO, stated, "Obtaining FDA approval and commencing commercialization of the PROTEGE RX Carotid Stent, which follows the previous clearance of the SpideRX Embolic Protection Device for use in treating carotid artery disease, are key milestones and evidence ev3's continued commitment to the endovascular field. We believe that the unique attributes of both the PROTEGE RX and SpideRX will permit ev3 to be a strong competitor in the carotid stenting market that we estimate could reach $250M worldwide in 2007."
In order to meet the growing requirements of a wide variety of physician specialties, the PROTEGE RX and the SpideRX devices, which are sold separately, will be represented by both the ev3 Cardio Peripheral and Neurovascular sales organizations. In addition to the United States, the PROTEGE RX and the SpideRX devices are commercially available in Canada, Europe and several countries in Latin America and Asia.
SOURCE: ev3 Inc.