The FDA has cleared the ENROUTE Transcarotid Neuroprotection System, the first system designed to access the carotid arteries through the neck rather than the groin. The device also features a blood flow reversal system to catch pieces of the dislodged blockage during the procedure.
During the procedure, the surgeon inserts a catheter above the stenosis in the neck, while the ENROUTE TNS captures dislodged parts of debris by temporarily shunting blood flow through the narrowed section of the artery away from the brain and through a filtering system outside of the body. Blood is returned to the body through a vein in the leg.
“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,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Device and Radiological Health, in an FDA news release. “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.”
In a clinical trial, the rate of stroke, heart attack, and death among patients who received treatment with the ENROUTE TNS was 3.5%, much lower than the study goal of 11%. About 14% of patients experiences at least one serious adverse event, including excessive bleeding or injury at the device access site, low blood pressure, and blood clot formation within the stent.
The FDA reviewed the ENROUTE TNS, which is manufactured by Silk Road Medical, through a 501(k) submission used for low to moderate risk medical devices that are substantially equivalent to legally marketed predicate device that is not subject to premarket approval. The system was found to be equivalent to a flow reversal system currently on the market that has the same intended use but is meant to be introduced to the body via the groin.
To read the full news release, go here.