SUNNYVALE, Calif., Dec. 12, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the 44th annual VEITH Symposium held November 15-19, 2016, in New York City featured several 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). Highlights include 1-year data on the pivotal cohort from ROADSTER 1 and the first interim analysis of the 30-day data from the ROADSTER 2 Post Approval Study.
Mahmoud Malas, MD, Director of Endovascular Surgery, Johns Hopkins Bayview Medical Center, and National Co-Principal Investigator for the ROADSTER 1 Long Term Follow-Up Study, presented "Midterm Results of the ROADSTER 1 Pivotal Trial of the Silk Road System for TransCarotid Artery Stent Revascularization (TCAR) In High Risk Patients with Carotid Stenosis." The objective of the ROADSTER 1 Long Term Follow-Up Study is to evaluate the incidence of ipsilateral stroke through one year for patients treated during the pivotal and continued access phases of the ROADSTER 1 Trial. In this ongoing retrospective review of the 141 patients treated in the pivotal phase, Dr. Malas reported outcomes for 87 patients with long term follow-up (median 1.3 years; range 0.5-2.9 years). In this cohort, one patient presented with an ipsilateral stroke following the periprocedural period for an overall one year ipsilateral stroke rate of 1.1%. Data collection in this cohort continues and will be published upon completion. Dr. Malas concluded that long term outcomes with TCAR are comparable to carotid endarterectomy (CEA) in the standard surgical risk population.
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