SUNNYVALE, Calif., April 17, 2015 /PRNewswire/ -- Silk Road Medical, Inc. announced the first U.S. commercial procedure using the ENROUTE Transcarotid Neuroprotection System (NPS) was successfully performed at Mills-Peninsula Medical Center in Burlingame, CA by Vascular Surgeon John E. Rosenman, M.D., F.A.C.S.
TCAR, or TransCarotid Artery Revascularization, uses direct carotid artery access and robust, temporary flow reversal to protect the brain from particles that can dislodge during the carotid artery repair procedure. The ENROUTE Transcarotid NPS recently received 510(k) clearance by the Food & Drug Administration (FDA).
"The TCAR procedure using the ENROUTE Transcarotid NPS allows me to perform a minimally invasive stent procedure expeditiously with less risk of nerve injury and less trauma to the patient than traditional open surgery." said Dr. Rosenman. "We are excited to be one of the first hospitals in the nation to offer this procedure to our patients with carotid artery disease. We are confident in the effectiveness of flow reversal for stroke prevention during stent placement. The transcarotid approach is a less invasive, more patient friendly option compared to traditional open surgery."
The FDA cleared the ENROUTE Transcarotid NPS based on the outcomes of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, a rate comparable to the gold standard of a surgical carotid endarterectomy (CEA) and the lowest to date for any prospective trial of carotid artery stenting. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age ≥75), women, and symptomatic patients.
"The surgical treatment of carotid artery disease to reduce the long term risk of stroke is well established, but many patients have risk factors that can lead to complications as a consequence of the procedure itself, including stroke, death, and cranial nerve injuries," said Sumaira Macdonald, M.D., Ph.D., Chief Medical Officer. "TCAR represents a procedural paradigm shift that brings together key principles of surgical and endovascular techniques to reduce these risks and is a welcome, clinically proven option for physicians and their patients."
Silk Road Medical will ramp up commercial operations throughout 2015 to broaden U.S. distribution of the ENROUTE Transcarotid NPS to vascular specialists. The ENROUTE Transcarotid NPS has been available internationally since 2012 and more than 500 patients have been treated with the device in the U.S. and Europe. The company also has a pending Premarket Approval (PMA) application for the ENROUTE Transcarotid Stent System – an optimized stent delivery system designed for use with the ENROUTE Transcarotid NPS.
About Silk Road Medical
Silk Road Medical, Inc. is a private company located in Sunnyvale, CA, that develops and manufactures less-invasive medical devices intended to improve the treatment of intra- and extra-cranial cerebrovascular disease through proprietary transcarotid therapies. Detailed information about Silk Road Medical can be found at www.silkroadmed.com.
SOURCE Silk Road Medical, Inc.