Excellent Outcomes for TCAR Across Multiple Carotid Artery Disease Patient Populations

Stroke prevention technologist, Silk Road Medical, Inc.,  tells us its ENROUTE® Transcarotid Neuroprotection and Stent System has been the subject of multiple presentations at 45th annual VEITHsymposium.

Background

TransCarotid Artery Revascularization (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.

Silk Road Medical’s ENROUTE Transcarotid Neuroprotection System (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.

The company points to data from this year’s VEITHsymposium, which it says add to the body of evidence supporting the use of the ENROUTE system. Presentations included:

  • “Recent Modifications of The TCAR System And Status of The ROADSTER 2 Trial to Evaluate Real World Usage and Value of The FDA Approved Device For TCAR”: an update on the ROADSTER 2 post-market study, evaluating real-world use of the ENROUTE Neuroprotection and Stent Systems in a broader group of operators with little or no TCAR experience. Procedural success rate (defined as acute device and technical success in the absence of stroke, death or myocardial infarction at 30 days) was 98.6% (n=365), and the stroke and death rate was 1.1% for patients with 30-day follow-up (n=362). More than 70% of the enrollment was from new TCAR operators.
  • “The Silk Road System for TransCarotid Access with Reversal of Flow to Perform TCAR: Results of The ROADSTER Trial Demonstrate Safety and Efficacy of The ENROUTE Version of The System: Lessons Learned”:  the use of TCAR in patient populations at an increased risk for stroke during transfemoral carotid artery stenting. Sub-group analyses of TCAR on elderly, symptomatic and female patients, showed stroke and cardiovascular/neurological death rates of 1.1%, 0% and 0%, respectively.
  • “Technical Tips for Safe, Effective TCAR with the ENROUTE System: When Is the Procedure Contraindicated”: expanded upon the technical aspects of TCAR published earlier this year in the Journal of Vascular Surgery. Concluded that TCAR is safe and effective in patients with high surgical risk factors, that use of the right tools for access is the key to achieving successful outcomes and that there are very few absolute contraindications to the use of TCAR.

Investigator comments

“TCAR is the next step,” said Dr. Peter Schneider, Chief of Vascular Therapy at Hawaii Permanente Medical Group and Kaiser Foundation Hospital Honolulu, and National Co-Principal Investigator of the ROADSTER 2 post-market study. “Carotid endarterectomy has been perfected over 50 years, but no matter how good it gets, it has certain inherent challenges that aren’t ever going to go away. My attitude now has really flip-flopped from that of tried and true surgery to what I think is the future of carotid artery repair.”

 

Company comments

“The clinical data presented at this year’s VEITHsymposium add to the growing body of evidence supporting the use of TCAR as a new approach to treating carotid artery disease,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. “We are particularly excited by the interim analysis of our ROADSTER 2 post-market study. It is more than half way enrolled and showing comparable results to our ROADSTER 1 Pivotal Study, which reported the lowest stroke rate in any prospective study of carotid revascularization.”

 

Source: Silk Road Medical, Inc.

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