FDA Clears Device for Reducing Stroke Risk

The U.S. Food and Drug Administration (FDA) has cleared a device designed to reduce stroke risk during stent and angioplasty procedures.

The Enroute transcarotid neuroprotection system (TNS), manufactured by Silk Road Medical Inc., is for use during minimally invasive procedures to restore normal blood flow to narrowed carotid arteries. It is designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood-flow reversal system to capture pieces of blockages dislodged during procedures, the company said.

Enroute TNS captures debris by temporarily shunting blood flowing through the narrowed section of the artery away from the brain and into a filtering system outside the body. Blood is then returned to the body though a vein in the leg.

“The Enroute technology enables a true hybrid procedure offering the best of both worlds –- the critical protection against peri-procedural stroke we’ve achieved with carotid endarterectomy (CEA) with the ability to reduce surgical complications using minimally invasive endovascular techniques (CAS),” said Manish Mehta, M.D., professor of Surgery at Albany Medical College and an Investigator in the Roadster trial. “It is also a quick, efficient procedure which can be performed under local anesthesia with minimal scarring, which is highly beneficial for both the patient and the operator.”

The FDA cleared the Enroute TNS based in part on the results of the Roadster trial, which achieved a 30-day stroke rate of 1.4 percent in the pivotal cohort, the lowest to date for any prospective trial of CAS. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age ≥75), women, and symptomatic patients.

“We continue to operate on high surgical risk patients because transfemoral CAS has shown excess peri-procedural stroke risk. With the Enroute Transcarotid NPS, we now have CEA-like neuroprotection and a simplified procedure that can fulfill the promise of CAS,” said Richard Cambria, M.D., chief of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and the National Co-Principal investigator of the Roadster trial along with colleague Christopher Kwolek, M.D.

“Clearance of the Enroute Transcarotid NPS is a result of the dedication of the Roadster investigators to their patients, the highly collaborative interaction with our colleagues at the FDA, and the hard work of our employees,” said Ric Ruedy, executive vice president for Clinical, Regulatory and Quality at Silk Road Medical.

Silk Road Medical also has submitted a premarket approval (PMA) application for the Enroute Transcarotid Stent System (Stent), which is an optimized stent delivery system designed for use with the Enroute Transcarotid NPS. “With clearance of the Enroute Transcarotid NPS in hand, we are on the eve of commercialization in the United States. Severe carotid artery stenosis is one of the last frontiers in vascular disease that is still treated primarily by an open surgical approach. We look forward to bringing our less invasive, surgically-inspired Enroute Systems to market for vascular specialists and their patients,” said Erica Rogers, Silk Road CEO.