Society for Vascular Surgery (SVS) Issues Guidance on Competence Recommendations for TCAR

Rhea-AI Summary

Silk Road Medical (Nasdaq: SILK) announced the release of a clinical competence statement on training for TransCarotid Artery Revascularization (TCAR), published in the Journal of Vascular Surgery. The statement includes three credentialing pathways for physicians to safely perform TCAR, aligning with Silk Road's training program. As of December 31, 2019, over 1,440 physicians have completed their training. The updated guidelines emphasize TCAR's safety, with low stroke and death rates shown in recent studies, underscoring its broad applicability in clinical practice.

Positive

• The newly released clinician competency statement supports the training standards for TCAR procedures.
• Over 1,440 physicians trained by Silk Road Medical as of December 31, 2019, indicating strong program uptake.
• Recent studies validate the effectiveness of TCAR, showing low stroke and death rates.

Negative

• None.

New Guidelines Consistent with Silk Road Medical Certification Process

SUNNYVALE, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the In-Press release of a clinical competence statement on training and credentialing for TransCarotid Artery Revascularization (TCAR), written by the SVS Writing Committee. The competence statement, published in the Journal of Vascular Surgery, provides recommendations on physician training and skills required to obtain and maintain clinical privileges to perform TCAR within an institution.

The statement outlines three credentialing pathways for physicians, providing multiple options to obtain the requisite endovascular and surgical skills. The physician training recommendations in the statement vary based on prior experience and, importantly, are consistent with the training program offered by Silk Road Medical. Recent data released in the Journal of the American College of Surgeons demonstrated the effectiveness of this curriculum with similar results in all major outcomes for TCAR among newly trained surgeons as well as their more experienced counterparts. The SVS guidance also cited evidence supporting the use of TCAR, including the low stroke and death rates observed in the PROOF and ROADSTER studies, as well as outcomes from the TCAR Surveillance Project, which demonstrate the broad applicability of TCAR in real world practice.

“We are committed to providing a comprehensive training program to physicians in support of their adoption of TCAR as a treatment option in their practices,” said Sumaira Macdonald, MD, Executive Medical Director at Silk Road Medical. “We are pleased to see that the SVS Writing Group’s credentialing recommendations are consistent with our approach and provide a clear pathway for physicians in several specialties to perform TCAR at their facilities.”

As of December 31, 2019, over 1,440 physicians have completed Silk Road Medical’s training programs.

For more information on the recently released guidance In Press, visit: https://www.jvascsurg.org/article/S0741-5214(20)31312-4/pdf

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 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 Caroline Paul
Gilmartin Group
investors@silkroadmed.com

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

FAQ

What is the significance of Silk Road Medical's new clinical competence statement for TCAR?

The competence statement outlines essential training and credentialing pathways for physicians performing TCAR, ensuring consistent quality and safety in the procedure.

How many physicians have completed training by Silk Road Medical as of December 2019?

As of December 31, 2019, over 1,440 physicians have completed Silk Road Medical's TCAR training programs.

What are the key findings related to TCAR from recent studies?

Recent studies indicate that TCAR procedures have low stroke and death rates, supporting its efficacy and broad applicability.

When was the clinical competence statement published?

The clinical competence statement was announced on June 30, 2020.