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Updated TCAR Data from Silk Road Medical’s ROADSTER 1 and 2 Studies Presented at VEITHsymposium

Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced multiple presentations at the 45th annual VEITHsymposium highlighting the safety and efficacy of the company’s ENROUTE® Transcarotid Neuroprotection and Stent System, the first and only products specifically designed and indicated for TransCarotid Artery Revascularization (TCAR).

“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.”

TCAR is a clinically proven, minimally invasive and safe approach to treating carotid artery disease. The data from this year’s VEITHsymposium add to the body of evidence supporting the use of Silk Road Medical’s 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” provided 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. Dr. Vikram Kashyap, Chief of Vascular Surgery and Endovascular Therapy at University Hospitals Case Medical Center and National Co-Principal Investigator of ROADSTER 2, reported that the 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” highlighted the use of TCAR in patient populations at an increased risk for stroke during transfemoral carotid artery stenting. Dr. Schneider, on behalf of Dr. Christopher Kwolek, Director of the Vascular and Endovascular Training Program at Massachusetts General Hospital, Chief of Vascular Surgery at Newton Wellesley Hospital, and National Co-Principal Investigator for the ROADSTER 1 Pivotal Study, shared sub-group analyses of TCAR on elderly, symptomatic and female patients, showing 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. Dr. Mahmoud Malas, Chief of Endovascular Surgery at Johns Hopkins Bayview Medical Center and National Co-Principal Investigator for the ROADSTER 1 Long-Term Follow-Up Study, 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.

“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.”

About Stroke and Carotid Artery Disease

Every year, 15 million people worldwide suffer a stroke. Nearly 6 million die and another 5 million are left permanently disabled. Stroke is the second leading cause of disability globally. Ischemic strokes account for 80-90 percent of strokes, and an estimated 20-30 percent of these are caused by disease in the carotid arteries that carry blood to the brain. If left untreated, these blockages can fragment, flow to the brain and lead to a potentially disabling stroke, also known as a “brain attack.”

About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System

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. 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.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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