Medical device firm Silk Road Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its Enroute Transcarotid Neuroprotection System (NPS).
The system has been developed to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS).
Silk Road Medical CEO Erica Rogers said: "With clearance of the Enroute Transcarotid NPS in hand, we are on the eve of commercialization in the US."
FDA approval was based on the results of Roadster trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, noted Silk Road.
Albany Medical College professor and Roadster trial investigator Dr Manish Mehta said: "The Enroute technology enables a true hybrid procedure offering the best of both worlds – the critical protection against peri-procedural stroke we’ve achieved with carotid endarterectomy (CEA) with the ability to reduce surgical complications using minimally invasive endovascular techniques (CAS)."
The company also submitted a premarket approval (PMA) application for Enroute Transcarotid Stent System, a stent delivery system developed for use with Enroute Transcarotid NPS.