FDA ha autorizzato la commercializzazione di ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), per l’utilizzo durante le procedure di ripristino del flusso sanguigno nelle carotidi. Si tratta del primo device progettato per accedere alla carotide attraverso un’incisione nel collo e non dall’inguine. Il sistema consente di “catturare” eventuali particelle che si staccano durante la procedura attraverso un sistema di filtraggio posto all’esterno del corpo. Il sangue è poi riimmesso nel corpo attraverso una vena della gamba. I dati che hanno permesso l’autorizzazione includono i risultato di uno studio che mostra come il tasso di stoke, attacco cardiaco e morte nel gruppo che ha utilizzato ENROUTE TNS (3.5%) fosse significativamente minore rispetto al target fissato dallo studio, dell’11%. Il sistema è prodotto dalla californiana Silk Road Medical.
The ENROUTE TNS allows physicians to insert a catheter into the artery in the neck above the narrowed or blocked section of the artery rather than having to enter through the groin. During the stenting procedure, physicians typically use a filter or additional balloon to capture and remove small pieces of debris that might be dislodged and potentially travel to the brain.
The ENROUTE TNS 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 though a vein in the leg. Because the carotid artery branches into many interconnected smaller arteries, the brain still receives oxygenated blood during the procedure.
“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, M.D., M.P.H., 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.”
The FDA reviewed the data for the ENROUTE TNS through a 510(k) submission, a regulatory pathway for low-to-moderate risk medical devices that are substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. 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.
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, heart attack, and death among the ENROUTE TNS patients was 3.5 percent, significantly lower than the study performance goal of 11 percent. At least one serious adverse event occurred in 14.2 percent of patients, including 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 ENROUTE TNS is manufactured by Silk Road Medical of Sunnyvale, California.