FDA Approves a Third Carotid Stent System

By Elizabeth Mechcatie

A third carotid stent system has been approved by the Food and Drug Administration, with a list of postmarketing study commitments that includes monitoring outcomes in recipients and evaluation of the adequacy of the training program for physicians using the device.

Last month, the FDA approved the Protégé GPS and Protégé RX carotid stent systems for treating patients with carotid artery disease who are at high risk for adverse events from carotid endarterectomy. The FDA requires use of the embolic protection devices made by the same company, approved by the FDA in February 2006, with the stent. Candidates for the stent must meet the following criteria:

• They must have common or internal carotid artery stenosis measuring 50% or greater if they are symptomatic, or 80% or greater if they are asymptomatic (as determined by ultrasound or angiography).
• They must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.

The Protégé carotid stent system, with the embolic protection device, was studied in the prospective, nonrandomized, multicenter Carotid Revascularization With ev3 Inc. Arterial Technology Evolution (CREATE) trial of 419 patients with carotid artery disease who were at risk for stoke and at high risk for adverse events from surgery.

The risk of death, stroke, and myocardial infarction at 30 days, or any stroke in the area of the blockage at 1 year, was similar to the rate of complications reported in the literature from patients undergoing surgery, according to the FDA. The study also showed that the stent still maintained blood flow to the brain more than 1 year after the procedure.

As part of the approval, the manufacturer, ev3, has agreed to conduct a long term follow-up study of patients from the CREATE study to evaluate the effectiveness and safety of the stent through 3 years after its implantation, according to the FDA approval letter. This will include performing a clinical exam, carotid duplex ultrasound, and neurologic exam annually. The company also will conduct a postapproval study of at least 1,500 patients from high-, moderate-, and low-volume centers who were treated by physicians with different categories of training.

The study will evaluate the composite rate of death, ipsilateral cerebrovascular accident (CVA), procedure-related CVA, or MI 30 days after the procedure in 1,000 patients. This study also will follow these patients and determine the rate of ipsilateral stroke at 12 months.

The Plymouth, Minn.-based company also agreed to implement a training program, and will provide the FDA with reports that evaluate the adequacy of this program.