Silk Road Medical’s Enroute TCAR System Approved for Expanded Indication of Standard-Risk Patients

May 2, 2022—Silk Road Medical, Inc. announced that the FDA approved expanded indications for the company’s Enroute stent for transcarotid artery revascularization (TCAR) to include patients at standard risk for adverse events from carotid endarterectomy (CEA). Previously, the stent was approved for use only in patients with anatomic or physiologic criteria that put them at high risk of complications from more invasive surgical procedures.

According to Silk Road Medical, the company had previously submitted a premarket approval supplement, which included data extracted from the Vascular Quality Initiative. The surveillance data included in the submission represented real-world outcomes in 20,264 patients considered at standard surgical risk.

Those data demonstrated that use of Silk Road Medical’s TCAR system is statistically noninferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (2.7% vs 0.3%; P ≤ .001), reported the company.

“Pairing the right patient with the right treatment results in significantly improved physician and patient experiences and outcomes,” commented Marc L. Schermerhorn, MD, in Silk Road Medical’s press release.

Dr. Schermerhorn, who is Chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts, continued, “The decision regarding which patients to treat with TCAR is no longer restricted to patients at high surgical risk, providing a greater opportunity for the care team to pursue the less invasive approach for a broader set of their patients. At Beth Israel Deaconess, going forward, we expect that the right treatment for the majority of our atherosclerotic carotid disease patients will be TCAR.”