Silk Road Medical has announced that it has received US Food & Drug Administration (FDA) 510(k) clearance for its Enroute transcarotid neuroprotection system. According to the company, the Enroute transcarotid neuroprotection system is a first in class system 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.
“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,” says Manish Mehta, 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 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 at Massachusetts General Hospital and the national co-principal investigator of the ROADSTER trial along with colleague Christopher Kwolek, comments: “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 fulfil 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.
Silk Road Medical has also submitted a Premarket Approval (PMA) application for the Enroute transcarotid stent system, which is an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system. “With clearance of the Enroute transcarotid neuroprotection system in hand, we are on the eve of commercialisation 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,” says Erica Rogers, chief executive officer.