UPDATED Feb. 10, 2015, with comments from trial investigators and Silk Road Medical.
The FDA today said it granted 510(k) clearance to the anti-stroke Enroute device made by Silk Road Medical.
The federal safety watchdog’s Center for Devices & Radiological Health said it cleared the Enroute transcarotid neuroprotection system for carotid stenting and angioplasty procedures. The device is designed to use a flow reversal system to capture dislodged pieces of carotid artery blockages via an incision in the neck, according to the FDA.
"Until today’s clearance, the only FDA-cleared systems to capture and remove debris and prevent them from reaching the brain during carotid angioplasty and stenting procedures required entry into the body through the femoral artery using an incision in the groin," Dr. William Maisel, acting director of the CDRH’s Office of Device Evaluation, said in prepared remarks. "The Enroute TNS provides a minimally-invasive treatment for certain patients whose tortuous (twisted) or diseased vasculature does not permit access via the groin for treating their narrowed carotid arteries."
The FDA said it based its clearance on data from a clinical trial sponsored by Sunnvale, Calif.-based Silk Road Medical, showing a significantly lower rate of stroke, heart attack and death among the Enroute TNS cohort of 3.5%, compared with a study performance goal of 11%.
There was at least 1 serious adverse event in 14.2% of patients, according to the study. Adverse events included 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 procedures," the FDA said.
"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 with the ability to reduce surgical complications using minimally invasive endovascular techniques," trial investigator Dr. Manish Mehta of the Albany Medical College said in prepared remarks. "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."
"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," added co-prinicipal investigator Dr. Richard Cambria of the Mass. General Hospital.
"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," CEO Erica Rogers said in a statement.