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Study Published in JAMA Finds Hospital Availability of TCAR Associated with an Improvement in Overall Outcomes for Carotid Revascularization

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SUNNYVALE, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced positive results from a comparative-effectiveness study have been published in JAMA Network Open.

The study found the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days after carotid revascularization, whether TCAR or carotid endarterectomy (CEA).

“Our results demonstrate that VQI centers who offer TCAR achieve lower rates of adverse events after carotid surgery when compared to centers who do not offer the new procedure,” said Jesse Columbo, MD MS, a vascular surgeon at Dartmouth and lead author of the study. “We believe this indicates that centers that offer TCAR are able to better align patients with the best procedure for their individual clinical and anatomic characteristics.”

The analysis studied 86,027 patients who underwent carotid procedures between 2015 and 2019 using retrospective data from the Vascular Quality Initiative registry, a consortium of more than 400 centers in North America. In total, 7,664 patients (8.9%) underwent TCAR and 78,363 patients (91.1%) underwent CEA. The analysis cited increased use of TCAR, with 15 centers performing both TCAR and CEA at the beginning of the analysis period (2015), increasing to 247 centers at the end of the analysis period (2019), which represents a more than 16-fold increase in centers performing TCAR. The use of TCAR as a percentage of total carotid revascularization procedures also increased, from 90 of 12,276 procedures (0.7%) in 2015 to 2,718 of 15,956 procedures (17.0%) in 2019, which represents a 24-fold increase over 5 years.

Importantly, the analysis also revealed centers that adopted TCAR had a 10% reduction in the likelihood of MACE at 12 months compared to those centers that continued to perform CEA alone (odds ratio, 0.90; 95%CI, 0.81-0.99; P = .04).

“The publication of these findings in JAMA is another powerful reminder that TCAR gives the vascular specialist more options when treating carotid artery disease to the benefit of all carotid patients,” said Erica Rogers, Chief Executive Officer. “We’re confident that as more and more practices adopt TCAR, providers will recognize the overall benefits of a less invasive approach and will further drive TCAR toward standard of care.”

JAMA Network Open is an international, peer-reviewed, open access, general medical journal with one of the highest Impact Factors among all open access general medicine journals. To read the published study and the invited commentary, visit: http://jamanetwork.com/article.aspx?doi=10.1001/jamanetworkopen.2020.37885

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 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’s flagship procedure, TransCarotid Artery Revascularization (TCAR), is clinically proven 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 Caroline Paul
Gilmartin Group
investors@silkroadmed.com

Media:
Michael Fanucchi
Silk Road Medical
mfanucchi@silkroadmed.com