The FDA paved the way for use of a neuroprotection and stent system that allows access to diseased carotid arteries through the neck rather than the femoral artery.
The FDA cleared the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical) after determining that the device is substantially equivalent to currently marketed flow reversal technology designed for femoral access. The device allows physicians to deliver stent systems directly through the carotid artery, with a high-rate flow reversal and filtering system to capture debris that might lead to stroke.
“The ENROUTE TNS [transcarotid neuroprotection system] 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,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Device and Radiological Health, in a release.
The FDA based its decision on results of the ROADSTER investigational device exemption trial. The study enrolled 208 patients at high risk of complications from carotid endarterectomy. At 30 days, the rate of stroke, MI and death was 3.5 percent in the intention-to-treat population. The 14.2 percent rate of serious adverse events was consistent with the other carotid artery procedures, according to the FDA.
The ENROUTE Transcarotid Neuroprotection System already has received CE mark in Europe.