First Ever Analysis of TCAR in Standard Surgical Risk Patients Demonstrates Clinical Benefits in Large Comparative Dataset
Large-Scale Analysis of TCAR in The Treatment of Standard Surgical Risk Patients Presented at The Society for Vascular Surgery 2021 Vascular Annual Meeting
SUNNYVALE, Calif., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, is pleased 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 today 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).
“The promise of safely preventing stroke while delivering benefits from a less-invasive approach is critically important as we consider an expanded patient population. This first ever large-scale, standard surgical risk analysis demonstrates that TCAR delivers on that promise,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical.
“These results reinforce the effectiveness of TCAR as an important treatment option for patients with carotid artery disease and standard surgical risk factors,” said Dr. Marc L. Schermerhorn, Chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center. “TCAR again shows equivalent risk to CEA of perioperative stroke, death, or MI and ipsilateral stroke at one year in patients undergoing carotid revascularization with improved secondary outcomes such as cranial nerve injury.”
The Society for Vascular Surgery Vascular Annual Meeting is attended by vascular surgeons and vascular health professionals. To view the abstract, visit: Expansion of Transcarotid Artery Revascularization to Standard Surgical Risk Patients for Treatment of Carotid Artery Stenosis
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
TCAR (TransCarotid Artery Revascularization) 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. The ENROUTE Transcarotid Stent is intended to be used in patients at high risk for complications from CEA, in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The ENROUTE Transcarotid NPS is a first in class device used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent.
About Silk Road Medical
Silk Road Medical, Inc. (NASDAQ: SILK), is a medical device company located in Sunnyvale, California, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new 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. For more information on how Silk Road Medical is delivering brighter patient outcomes through brighter clinical thinking, visit www.silkroadmed.com and connect on Twitter, LinkedIn and Facebook
Investors:
Lynn Lewis or Marissa Bych
Gilmartin Group
investors@silkroadmed.com
Media:
Michael Fanucchi
Silk Road Medical
mfanucchi@silkroadmed.com
