Presentations from the ROADSTER Study Highlight the Continued Safety, Efficacy and Durability of TransCarotid Artery Revascularization
SUNNYVALE, Calif., June 15, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the 2016 Vascular Annual Meeting of the Society for Vascular Surgery (SVS) held June 8-11 in National Harbor, MD featured six presentations on the company's ENROUTE® Transcarotid Neuroprotection and Stent System, the first and only products specifically designed and indicated for TransCarotid Artery Revascularization (TCAR).
Christopher Kwolek, MD, Director of the Vascular and Endovascular training program at Massachusetts General Hospital, Chief of Vascular Surgery at Newton Wellesley Hospital, and National Co-Principal Investigator for the ROADSTER Trial, presented "TransCarotid Artery Revascularization with High-Rate Flow Reversal Embolic Protection Demonstrates Improved Stroke and Death Rate Following FDA Premarket Clearance." Dr. Kwolek presented a 30 day all stroke rate of 1.3% from the Continued Access cohort of patients from the ROADSTER trial, which consisted of an additional 78 high surgical risk patients enrolled beyond the Pivotal cohort of 141 patients while the Pre Market Clearance Application was under review by the Food & Drug Administration (FDA). This compares to a 30 day all stroke rate of 1.4% in the Pivotal cohort, for a combined rate of 1.4% in 219 patients. The 30 day stroke and death rates were 2.8%, 1.3% and 2.3% in the Pivotal, Continued Access, and combined cohorts, respectively. Dr. Kwolek commented that "the combined outcomes in high surgical risk patients are remarkably better than high surgical risk patients treated with conventional carotid endarterectomy (CEA)."
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