ev3 has gained FDA approval of the Protege RX Carotid Stent for indications for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. The stent is used in conjunction with the ev3 embolic protection device, SpideRX Embolic Protection Device (EPD) was previously FDA cleared for carotid use in February 2006.
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. According to the company, the SpideRX EPD 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.
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 SpideRX EPD. 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 primary endpoints were 30-day stroke, death or MI and one-year ipsilateral stroke.
Dr Gary Ansel, Riverside Hospital, Columbus, OH, 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 Prot©g© 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 EPD 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.”
The 30-day results from the Phase I CREATE demonstrated that the Protege stent has a lower rate of myocardial infarction, stroke or death 30 days after treatment than its predecessor. The trial involved 419 patients. In this cohort, 60% were men and the average age was 74 years. The rate of major adverse cardiac events at 30 days for the Protege stent and the SpideRX EPD was 4.8%. Successful stent deployment was achieved in 97.8% of procedures. Success was defined as deployment and recapture of the filter, stent deployment over the filter, and final stenosis in fewer than 50%. The major adverse cardiac events rate typically ranges from 11% to 15% at 30 days in endarterectomy trials. Previously, the Acculink for Revascularisation of Carotids in High Risk Patients (ARCHeR) trial achieved a rate of 7.8% at that time point.
Data at 30 days were obtained on 400 patients; 17.5% were symptomatic. High-risk patients were those with greater than 75 years of age (50.3% of patients), with history of restenosis (23.3%), with coronary artery disease affecting more than two vessels (14.3%), left ventricular ejection of less than 35% (9.5%), and severe pulmonary disease (4.0%). Among the overall patient group, 39.5% fulfilled two or more of these criteria. The mortality rate was 1%; the rate for any stroke was 3.3%, 2.3% for major stroke; the rate for myocardial infarction was 0.5%. The event rates at 30 days plus one-year were as follows: death (7.4%), all stroke (6.6%), ipsilateral stroke (5.3%), MI (1.0%) (all, non-hierarchical).
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 US$250 million 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 US, the Protege RX and the SpideRX devices are commercially available in Canada, Europe and several countries in Latin America and Asia.