FDA Clears Silk Road Medical's Enroute Transcarotid Neuroprotection System

February 10, 2015—Silk Road Medical, Inc. announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its Enroute transcarotid neuroprotection system (NPS), which is used to directly access the common carotid artery and initiate high-rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS).

According to Silk Road Medical, the FDA cleared the Enroute NPS based in part on the results of the ROADSTER trial, which achieved a 30-day stroke rate of 1.4% in the pivotal cohort. There were no major strokes and there were no strokes in important high-risk subgroups, including the elderly (age ≥ 75 years), women, and symptomatic patients.

Manish Mehta, MD, an investigator in the ROADSTER trial, commented in the company’s press release, “The 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 (CEA), with the ability to reduce surgical complications using minimally invasive endovascular techniques (CAS). It is also a quick, efficient procedure that can be performed under local anesthesia with minimal scarring, which is highly beneficial for both the patient and the operator.”  Dr. Mehta is Professor of Surgery at Albany Medical College in Albany, New York.

Richard Cambria, MD, the ROADSTER National Co-Principal Investigator, added, “We continue to operate on high-surgical-risk patients because transfemoral CAS has shown excess periprocedural stroke risk. With the Enroute transcarotid NPS, we now have CEA-like neuroprotection and a simplified procedure that can fulfill the promise of CAS.”

Dr. Cambria is Chief of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital in Boston, Massachusetts. Christopher Kwolek, MD, also serves as National Co-Principal Investigator of the ROADSTER trial.

Silk Road Medical has also submitted a premarket approval application to the FDA for the Enroute transcarotid stent system, which is designed for use with the Enroute transcarotid NPS.