FDA Clears System to Reduce Stroke Risk During Stent and Angioplasty Procedures

It has cleared for marketing the ENROUTE Transcarotid Neuroprotection System for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries.

The U.S. Food and Drug Administration announced it has cleared for marketing the ENROUTE Transcarotid Neuroprotection System for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries.

Manufactured by Silk Road Medical of Sunnyvale, Calif., ENROUTE TNS is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin. It uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure, FDA's news release explained.

FDA said National Heart Lung and Blood Institute data show that more than half of the strokes occurring in the United States annually are caused by carotid artery disease.

A surgeon may address a severe narrowing or blockage of the carotid artery by performing a minimally invasive balloon angioplasty, where a balloon on a catheter is threaded through the patient's vasculature from the groin to the site of the blockage, inflated to open the artery, and then a small mesh tube called a stent is placed at the site to keep the artery open. ENROUTE TNS allows physicians instead to insert a catheter into the artery in the neck above the narrowed or blocked section of the artery, then the system captures debris by temporarily shunting blood flowing through the narrowed section of the artery away from the brain and into a filtering system outside the body. Blood is then returned to the body though a vein in the leg. The patient's brain still receives oxygenated blood during the procedure.

"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," said Dr. William Maisel, M.D., MPH, acting director of the Office of Device Evaluation at FDA's Center for Device and Radiological Health. "The ENROUTE TNS provides a minimally invasive treatment for certain patients whose tortuous (twisted) or diseased vasculature does not permit access via the groin for treating their narrowed carotid arteries."

FDA reviewed the data for the ENROUTE TNS through a 510(k) submission, a regulatory pathway for low-to-moderate risk medical devices that are substantially equivalent to a legally marketed predicate device that is not subject to premarket approval.

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