EV3 RECEIVES FDA NOD FOR CAROTID ARTERY STENTING DEVICE

The FDA has granted 510k clearance for device firm ev3's SpideRX Embolic Protection Device, which is used in carotid artery stenting applications.

The device will be released immediately for commercial sale, ev3 said. The FDA clearance was supported by a 160 patient high-risk carotid stent registry as part of ev3's CREATE Carotid Registry and was designed to evaluate the SpideRX rapid exchange embolic protection device for use with the Guidant RX Acculink Carotid Stent System.

Carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. When narrowing occurs, patients are at risk for stroke. Stroke is the nation's third leading cause of death, affecting nearly 700,000 Americans each year. Embolic protection devices are small filters placed beyond a blockage in the carotid arteries to collect debris released during stent placement to prevent a stroke or other

neurological event.

"The SpideRX Device is unique in that it allows physicians to utilize their own wire system of choice, leading to consistent success in placing the embolic protection device during carotid interventions," said Gary Ansel, the national coprincipal investigator for the trial.