The Food and Drug Administration (FDA) has cleared for marketing Silk Road Medical’s ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries.
ENROUTE TNS is the first device designed to access the carotid arteries through an incision in the neck above the narrowed or blocked section of the artery (rather than the groin). The System captures debris by temporarily shunting blood flowing through the narrowed section of the artery away from the brain and into a filtering system outside the body; blood is then returned to the body via a vein in the leg.
The FDA clearance is supported by data from a clinical trial which showed that the rate of stroke, heart attack, and death among the ENROUTE TNS patients was 3.5%, which was significantly lower than the study performance goal of 11%. The rate of at least one serious adverse event occurring in 14.2% of patients was consistent with the rate of serious adverse events associated with other carotid artery procedures.
For more information visit FDA.gov.