FDA Gives Nod to Silk Road’s Enroute Stroke Prevention System

The FDA granted 510(k) clearance to Silk Road Medical's Enroute Transcarotid Neuroprotection System for use in preventing stroke during carotid artery stenting, the company said Tuesday. The device allows physicians to directly access the carotid artery and temporarily reverse blood flow to protect the brain.

Clearance was based on results from the Roadster trial, which demonstrated a 30-day stroke rate of 1.4 percent in the pivotal cohort — the lowest to date of any prospective CAS trial, the Sunnyvale, Calf., devicemaker said. There were no major strokes and no strokes in high-risk subgroups such as the elderly, women and symptomatic patients, the company added.

"Enroute technology enables a true hybrid procedure offering the best of both worlds — the critical protection against periprocedural stroke we've achieved with carotid endarterectomy with the ability to reduce surgical complications using minimally invasive endovascular techniques,” said Manish Mehta of Albany Medical College, an investigator in the trial.

The procedure is quick and efficient and can be done under local anesthesia with minimal scarring, Mehta added.

Silk Road has submitted a premarket approval application to the FDA for the Enroute Transcarotid Stent System, a companion stent delivery system to be used with the NPS. — Kellen Owings