The US Food and Drug Administration (FDA) has granted 510(k) clearance for Silk Road Medical’s Enroute Transcarotid Neuroprotection System (NPS).
The system is designed to directly access the common carotid artery, and start high-rate temporary blood flow reversal to protect the brain from stroke while performing carotid artery stenting (CAS).
CAS is an endovascular surgery where a stent is deployed within the lumen of the carotid artery to prevent a stroke by treating carotid artery stenosis.
The FDA clearance was based in part on results of the Roadster trial, which achieved a 30-day stroke rate of 1.4% in the pivotal group, the lowest to date for any prospective trial of CAS.
Albany Medical College professor of surgery Dr Manish Mehta said: "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 which can be performed under local anaesthesia with minimal scarring, which is highly beneficial for both the patient and the operator."
According to the company, there were no major strokes and no strokes in important high-risk subgroups, including the elderly over the age of 75, women and symptomatic patients.
Silk Road Medical CEO Erica Rogers said: "With clearance of the Enroute Transcarotid NPS in hand, we are on the eve of commercialisation in the US."
"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."
The company also submitted a premarket approval (PMA) application for Enroute Transcarotid Stent System, a stent delivery system designed for use with Enroute Transcarotid NPS.