ROADSTER-2 Demonstrates Compelling Patient Outcomes With Strong Safety Profile

Silk Road Medical Inc., a company focused on reducing the risk of stroke and its impact, announced positive final results for the company’s ROADSTER-2 post-marketing study evaluating real world use of the ENROUTE Neuroprotection and Stent Systems in TransCarotid Artery Revascularization (TCAR) procedures.
 
The study demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6 percent and 0.8 percent, respectively, in 632 high surgical risk patients enrolled across 42 sites. Seventy percent of patients enrolled in the study were from physicians new to TCAR.
 
“The results of ROADSTER-2 continue to demonstrate the safety, effectiveness and clinical advantages of TCAR, especially given that a majority of the TCAR procedures were performed by a broad group of physicians with no previous TCAR experience,” said Dr. Vikram Kashyap, chief of Vascular Surgery and Endovascular Therapy at University Hospitals Case Medical Center (Cleveland, Ohio) and national co-principal investigator of ROADSTER-2. “The study results highlight the short learning curve of the TCAR procedure and its remarkable consistency and reproducibility, and, I believe, will further encourage physicians to broadly adopt the TCAR procedure.”
 
Designed as a follow-on study to the pivotal ROADSTER trial, ROADSTER-2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure. The study met its primary endpoint of procedural success, defined as acute device and technical success in the absence of stroke, death or myocardial infarction (MI) at 30 days, at 97.9 percent.
 
Significant findings from the study showed TCAR to have low rates of 30-day major adverse events, including:

• 1.7 percent stroke, death and MI
• 0.8 percent stroke and death
• 0.6 percent stroke, including 0.6 percent in symptomatic patients, 0.5 percent in females, and 1.1 percent in patients age greater than 75

 
In addition, ROADSTER-2 showed lower rates of acute (1.3 percent) and permanent (0.5 percent) cranial nerve injury than is typically observed for patients receiving carotid endarterectomy (CEA), the current standard of care.
 
“The mounting clinical evidence base demonstrates the compelling patient benefits of TCAR, which we believe will further support physician confidence and adoption. The data from ROADSTER-2, taken together with recent updated results from the TCAR Surveillance Project, supports the case for TCAR as the standard of care in high surgical risk patients,” said Erica Rogers, Silk Road Medical’s CEO.

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.
 
Silk Road Medical Inc. is a medical device company located in Sunnyvale, Calif., that has developed 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.
 
ENROUTE is a registered trademark of Silk Road Medical Inc.