The US Food and Drug Administration (FDA) has cleared the Enroute Transcarotid Neuroprotection System (Enroute TNS, Silk Road Medical) to reduce the risk for stroke during carotid angioplasty and stenting, the first such device to use neck rather than groin access.
"It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure," a statement released by the FDA today notes.
During the procedure, the operator inserts a catheter into the neck above the stenosis; the system captures debris by temporarily shunting blood flowing through the narrowed section of artery away from the brain and into a filtering system outside the body. Blood is then returned to the body through a vein in the leg. "Because the carotid artery branches into many interconnected, smaller arteries, the brain still receives oxygenated blood during the procedure," the FDA statement notes.
"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.
"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," Dr Maisel said.
The FDA reviewed data for the new system through a 510(k) submission, a regulatory pathway for medical devices of low to moderate risk that are substantially equivalent to a legallyv marketed predicate device that is not subject to premarket approval, the agency notes.
"In this case, the FDA found the Enroute TNS to be substantially equivalent to a flow reversal system currently on the market that uses similar technology and has the same intended use but is designed to be introduced into the patient through the blood vessels in the groin," the statement said.
Data supporting the FDA's clearance included the results from a clinical trial sponsored by the manufacturer. The trial showed that the rate of stroke, myocardial infarction, and death among the Enroute TNS patients 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 in-stent thrombosis.
"These events are consistent with the type and rate of serious adverse events associated with other carotid artery procedures," the statement said.
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Cite this: FDA Clears First Neck-Access Neuroprotection for Carotid Stenting - Medscape - Feb 09, 2015.
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