FDA Approves Precise Carotid Stent And Emboli Filter

By Elizabeth Mechcatie

The Food and Drug Administration has approved the Precise Nitinol Stent System for use with an emboli-trapping device to treat patients "at high risk for adverse events from carotid endarterectomy" who require carotid revascularization and meet certain criteria, according to the approval letter issued by the agency in late September.

The Cordis Corp., a subsidiary of Johnson & Johnson, manufactures the system and the emboli-trapping device, the Angioguard Emboli Capture Guidewire.

The treatment criteria, outlined in the approval letter, are neurologic symptoms and at least 50% stenosis of the common or internal carotid artery measured by ultrasound or angiogram, or no neurologic symptoms but at least 80% stenosis of the common or internal carotid artery. The target lesion must also measure 4-9 mm in diameter, and the vessel distal to the target lesion "must be within the range of 3 mm and 7.5 mm to allow for the placement" of the Angioguard guidewire, the letter says.

The approval was based on certain conditions, which include the company's agreeing to perform postapproval studies. Those studies include a follow-up study of patients from the original study, which will evaluate the safety and effectiveness of the stent system for up to 3 years after implantation, and to evaluate adverse events, neurologic events, and percent stenosis of the lesions.

The letter says the company has agreed to provide physicians with clinical updates on the device, which will include major adverse event rates, including stroke, at different time points up to 3 years, and rates of "freedom from target lesion and vessel revascularization, stent thrombosis, and events related to the device or procedure."

Approval is based on 3-year data from the Stenting and Angioplasty With Protection in Patients at High-Risk for Endarterectomy (SAPPHIRE) trial of patients who are ineligible or considered at high risk for carotid endarterectomy, which compared safety and effectiveness of the device with carotid endarterectomy, according to the Johnson & Johnson statement. Preliminary 3-year data from the SAPPHIRE trial were presented last October at the Transcatheter Cardiovascular Therapeutics meeting.

At 36 months, the incidence of stroke was 7.1% among those randomized to carotid artery stenting and 6.7% for those who underwent carotid endarterectomy, a nonsignificant difference.

The approval makes Precise the third carotid stent and embolic protection system to enter the U.S. market, behind Abbott Laboratories' Acculink and Xact, approved in 2004 and 2005, respectively.