First Ever Analysis of TCAR in Standard Surgical Risk Patients Demonstrates Clinical Benefits in Large Comparative Dataset

Rhea-AI Summary

Silk Road Medical (NASDAQ: SILK) announced positive findings from a large-scale analysis on Transcarotid Artery Revascularization (TCAR) presented at the Society for Vascular Surgery 2021 Vascular Annual Meeting. The study involved over 20,000 patients, revealing that TCAR achieved similar stroke and death rates compared to carotid endarterectomy (CEA), but with a significant ninefold reduction in cranial nerve injury (CNI) incidents (0.3% vs 2.7%, p=<0.001). These results highlight the effectiveness of TCAR as a less invasive treatment option for carotid artery disease.

Positive

• TCAR shows statistically equivalent outcomes for stroke and death compared to CEA.
• Ninefold reduction in cranial nerve injury with TCAR (0.3% vs 2.7%, p=<0.001).
• Increased adoption potential of TCAR for standard surgical risk patients.

Negative

• None.

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

FAQ

What were the main findings about TCAR presented at the 2021 Vascular Annual Meeting?

The analysis indicated that TCAR had similar outcomes for stroke and death compared to CEA, with a ninefold reduction in cranial nerve injury.

How many patients were included in the TCAR analysis?

The analysis included over 20,000 patients, with 15,198 undergoing CEA and 5,066 undergoing TCAR.

What is the significance of the study results for Silk Road Medical and its stock SILK?

The positive findings reinforce the effectiveness of TCAR and could enhance its market position, potentially benefiting SILK's stock performance.

What does TCAR stand for in Silk Road Medical's analysis?

TCAR stands for Transcarotid Artery Revascularization, a procedure aimed at treating blockages in the carotid artery.

When was the TCAR study presented?

The study was presented on August 18, 2021, at the Society for Vascular Surgery 2021 Vascular Annual Meeting.