FDA Approves Device for Procedure-Related Stroke
The transcarotid system designed to help prevent stroke during stent and angioplasty procedures.
(HealthDay News) -- The ENROUTE Transcarotid Neuroprotection System (TNS) has been approved by the U.S. Food and Drug Administration as a minimally invasive device designed to help prevent stroke during stent and angioplasty procedures.
The system is the first such device designed to access the carotid arteries via the neck, the FDA said Monday in a news release. It uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
Clinical studies showed the ENROUTE TNS was effective in preventing cases of stroke, heart attack, and death, the FDA said. Serious adverse reactions, however, included excessive bleeding at the access site, low blood pressure, and blood clot formation within the implanted stent.
"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," William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA's Center for Device and Radiological Health, said in the FDA news release. "The ENROUTE TNS provides a minimally-invasive treatment for certain patients whose tortuous or diseased vasculature does not permit access via the groin for treating their narrowed carotid arteries."
The ENROUTE system is produced by Silk Road Medical, based in Sunnyvale, Calif.