Silk Road Medical’s Enroute System for TCAR Evaluated in Standard Surgical Risk Patients

August 18, 2021—Silk Road Medical, Inc. announced results from an independent analysis of standard surgical risk patients undergoing carotid endarterectomy (CEA) and transcarotid artery revascularization (TCAR) for atherosclerotic carotid disease. The data were presented at the Society for Vascular Surgery’s 2021 Vascular Annual Meeting held August 18-21 in San Diego, California.

The company noted that this was the first presentation of outcomes for TCAR in standard surgical risk patients. Silk Road’s Enroute transcarotid stent is intended to be used in patients at high risk for complications from CEA, in conjunction with the Enroute transcarotid neuroprotection system during the TCAR procedure.

According to Silk Road Medical, > 20,000 standard surgical risk patients were included in the analysis (15,198 CEA and 5,066 TCAR) from the Vascular Quality Initiative’s CEA and carotid artery stent registries from August 2016 to September 2020.

The results for symptomatic and asymptomatic standard surgical risk patients undergoing CEA and TCAR for atherosclerotic carotid disease showed that TCAR had statistically equivalent stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (2.7% vs 0.3%; P ≤ .001). The abstract of the study, Expansion of Transcarotid Artery Revascularization to Standard Surgical Risk Patients for Treatment of Carotid Artery Stenosis, is available online.

“These results reinforce the effectiveness of TCAR as an important treatment option for patients with carotid artery disease and standard surgical risk factors,” commented Marc L. Schermerhorn, MD, in the company’s announcement. “TCAR again shows equivalent risk to CEA of perioperative stroke, death, or myocardial infarction and ipsilateral stroke at 1 year in patients undergoing carotid revascularization with improved secondary outcomes such as cranial nerve injury.” Dr. Schermerhorn is Chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

Silk Road Medical’s President and Chief Executive Officer Erica Rogers stated, “The promise of safely preventing stroke while delivering benefits from a less-invasive approach is critically important as we consider an expanded patient population. This first-ever large-scale, standard surgical risk analysis demonstrates that TCAR delivers on that promise.”