US FDA clears Enroute transcarotid neuroprotection system

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The US FDA has cleared the Enroute transcarotid neuroprotection system (Silk Road Medical) for marketing. The system is for use during carotid artery stenting procedures and is the first one designed to access the carotid arteries through an incision in the neck, instead of the groin. It uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.

“The ENROUTE technology enables a true hybrid procedure offering the best of both worlds– the critical protection against peri-procedural stroke we have achieved with carotid endarterectomy with the ability to reduce surgical complications using minimally invasive endovascular techniques,” said Manish Mehta, professor of Surgery, Albany Medical College, Albany, and an investigator in the ROADSTER trial. “It is also a quick, efficient procedure which can be performed under local anaesthesia with minimal scarring, which is highly beneficial for both the patient and the operator.” 

Richard Cambria, chief of the Division of Vascular and Endovascular Surgery, Massachusetts General Hospital and the national co-principal investigator of the ROADSTER trial along with colleague Christopher Kwolek, said: “We continue to operate on high surgical risk patients because transfemoral carotid artery stenting has shown excess peri-procedural stroke risk.  With the Enroute transcarotid neuroprotection system, we now have carotid endarterectomy-like neuroprotection and a simplified procedure that can fulfill the promise of carotid artery stenting.”

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

A press release from the US FDA said: “The trial showed the rate of stroke, heart attack, and death among the patients who received the Enroute system was 3.5%, significantly lower than the study performance goal of 11%. At least one serious adverse event occurred in 14.2% of patients, including excessive bleeding or injury at the device access site, low blood pressure due to the device or procedure, and blood clot formation within the placed stent. These events are consistent with the type and rate of serious adverse events associated with other carotid artery stenting procedures.”

Silk Road Medical has also submitted a premarket approval application for the Enroute transcarotid stent system, which is an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system.