The Food and Drug Administration has approved a minimally invasive angioplasty system that enters the carotid artery adjacent to a blockage, and captures embolic debris by extracorporeal filtration of blood near the blockage.
The ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS) is inserted into the artery near the stenotic region. As the stent is deployed, the system draws blood down the tube, away from the brain, under high pressure. An extracorporeal filter traps any emboli, and the filtered blood is returned via the femoral vein.
ENROUTE TNS was approved on the basis of the successful ROADSTER trial (Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure). In this study, there was a 3.5% rate of stroke, heart attack, and death among patients treated with the device – significantly lower than the study’s primary outcome goal of 11%. The rate of adverse events was about 14%; these included excessive bleeding or injury at the device insertion site, hypotension, and thrombosis.
The system’s benefits include its minimally invasive approach and the ability to successfully navigate severe carotid tortuosity. It also may be more successful than traditional arterial angioplasty for patients with difficult anatomy of the aortic arch, according to an FDA statement .
Manufactured by Silk Road , Sunnyvale, Calif., the ENROUTE TNS device was approved through a 510(k) submission, which provides an approval pathway for low- to moderate-risk devices that are substantially equivalent to a legally marketed device. According to the FDA statement, ENROUTE TNS is equivalent to a currently marketed flow-reversal system that uses similar technology and has the same intended use, but is designed to be introduced through the groin.
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