Silk Road Medical, Inc Announce First Ever Analysis of TCAR in Standard Surgical Risk Patients Demonstrates Clinical Benefits in Large Comparative Dataset
August 18, 2021 at 04:15 pm EDT
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Silk Road Medical Inc. to highlight positive results from an independent analysis of standard surgical risk patients undergoing carotid endarterectomy (CEA) and transcarotid artery revascularization (TCAR) for atherosclerotic carotid disease. The analysis, presented at the Society for Vascular Surgery 2021 Vascular Annual Meeting (VAM) in San Diego, California, is the first ever presentation of outcomes for TCAR in standard surgical risk patients. Over 20,000 standard surgical risk patients were included in the analysis (15,198 CEA and 5,066 TCAR) from the VQI CEA and carotid artery stent (CAS) registries over 4 years (August 2016 to September 2020). The results for symptomatic and asymptomatic standard surgical risk patients undergoing CEA and TCAR for atherosclerotic carotid disease showed that TCAR had statistically equivalent stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (CNI) (2.7% vs 0.3%, p=<0.001).
Silk Road Medical, Inc. is a medical device company that is focused on reducing the risk of stroke and its impact. The Company has developed an approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. Its product portfolio consists of five single-use components: ENROUTE Transcarotid Neuroprotection System, ENROUTE Transcarotid Stent System, ENHANCE Transcarotid Peripheral Access Kit, ENROUTE 0.014'' Guidewire and ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter. It manufactures ENROUTE NPS and ENROUTE NPS PLUS, or its ENROUTE NPS products, at its facilities in Sunnyvale, California and Plymouth, Minnesota. These facilities provide an aggregate of over 35,000 square feet of space for its production and distribution operations.
Silk Road Medical, Inc Announce First Ever Analysis of TCAR in Standard Surgical Risk Patients Demonstrates Clinical Benefits in Large Comparative Dataset