ROADSTER 2 Data Publication in Stroke Demonstrates Compelling Patient Outcomes and Strong Safety Profile with TCAR

SUNNYVALE, Calif., Aug. 19, 2020 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that ROADSTER 2 study results have been published in the latest edition of the American Heart Association’s journal, Stroke. The article, “Early Outcomes in the ROADSTER 2 Study of TransCarotid Artery Revascularization (TCAR) in Patients with Significant Carotid Artery Disease” demonstrates compelling patient outcomes with low stroke and combined stroke and death rates when utilizing TCAR.

“The publication of the ROADSTER 2 data in Stroke provides further validation of the work we are doing to improve patient safety and deliver strong clinical outcomes. With more than 600 patients studied by investigators of varying experience, these data demonstrate the broad applicability of TCAR as a tool for stroke prevention,” said Erica Rogers, Chief Executive Officer of Silk Road Medical. “We are honored that ROADSTER 2 was included in this prestigious, widely read, peer reviewed journal as we continue our mission to broaden TCAR adoption.”

The ROADSTER 2 data show stroke and combined stroke and death rates comparable to CEA in 692 high surgical risk patients enrolled in the FDA analysis population, across 43 sites. Sixty-two percent (62%) of patients enrolled in the study were from physicians new to TCAR. In addition, ROADSTER 2 shows lower rates of acute and persistent cranial nerve injury than is typically observed for patients receiving carotid endarterectomy (CEA), the current standard of care.

“The peer-reviewed publication of these data in Stroke reinforces the effectiveness of TCAR as an optimal treatment option for patients with carotid artery disease and high surgical risk factors,” said Dr. Vikram Kashyap, Chief of Vascular Surgery and Endovascular Therapy at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center (Cleveland, OH) and National Co-Principal Investigator of ROADSTER 2. “TCAR continues to show a low stroke and death rate with lower rates of cranial nerve injury compared to CEA, which we believe will further instill physician confidence and adoption.”

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.

Stroke has an audience of 23,900 neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists. To read the published study, visit: https://www.ahajournals.org/doi/10.1161/STROKEAHA.120.030550

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.