FDA Clears Transcarotid Neuroprotection System to Reduce Stent-Related Stroke Risk

On Feb. 9, the U.S. Food and Drug Administration (FDA) cleared the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) for marketing. The system restores normal blood flow to narrowed carotid arteries through an incision in the neck rather than the groin. It uses a blood flow reversal system to temporarily divert blood flowing through the narrowed or blocked artery away from the brain to a filtering system outside of the body. The blood is returned to the body through a vein in the leg. The ENROUTE TNS’ blood flow reversal system also allows it to retrieve any pieces of the blockage that become dislodged during minimally invasive procedures, reducing the risk of stroke.

“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 William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Device and Radiological Health, in the FDA’s announcement. “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.”

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Angioplasty, Brain, Carotid Arteries, Femoral Artery, Radiologic Health, Stents, Stroke, United States Food and Drug Administration

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