Updated TCAR Data from Silk Road Medical’s ROADSTER 1 and 2 Studies Presented at VEITHsymposium 2017

“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 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 Carotid Artery Disease and Stroke
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.