FDA Approves New Device Aimed at Easing Stroke Risk By Robert Preidt

HealthDay Reporter

MONDAY, Feb. 9, 2015 (HealthDay News) -- A new technology designed to reduce stroke risk in certain patients has been approved by the U.S. Food and Drug Administration, the agency announced Monday.

The ENROUTE Transcarotid Neuroprotection System (TNS) is the first device designed to access the carotid (neck) arteries through an incision in the neck, instead of the groin, the agency explained.

The system was approved for use in people who are undergoing procedures to restore normal blood flow in narrowed neck arteries.

The system also has a "blood flow reversal system," to capture bits of blockage in the arteries that are dislodged during angioplasty and stenting.

The carotid arteries supply blood to the brain, but can be narrowed or blocked by accumulations of cholesterol or fatty substances called plaque. If a piece of plaque breaks off, it can travel to the brain and cause a stroke.

Carotid artery disease causes more than half of the strokes in the United States, according to the National Heart, Lung, and Blood Institute.

"Until today's clearance, the only FDA-cleared systems to capture and remove debris and prevent them from reaching the brain during carotid angioplasty and stenting procedures required entry into the body through the femoral artery using an incision in the groin," explained Dr. William Maisel in an FDA news release. He is acting director of the Office of Device Evaluation at the FDA's Center for Device and Radiological Health.

He said the new system is meant for patients who have twisted or "tortuous" vessels that do not "permit access via the groin for treating their narrowed carotid arteries."

One expert applauded the FDA approval.

"This is a novel approach to 'cleaning out' harmful plaque that has been shown to cause strokes," said Dr. Paul Wright, chair of neurology at North Shore University Hospital in Manhasset, N.Y.

"Until now, the only options available are carotid stenting and open surgery," he explained. "Carotid stenting involves entering the groin and traveling all the way up to the plaque site."