Silk Road’s Enroute System Receives Expanded Medicare Coverage for TCAR in Standard Surgical Risk Patients

June 2, 2022—Silk Road Medical, Inc. announced that the Centers for Medicare & Medicaid Services (CMS), through collaboration with the Society for Vascular Surgery (SVS)’s Patient Safety Organization and its Vascular Quality Initiative (VQI) has expanded coverage for transcarotid artery revascularization (TCAR) to include standard surgical risk patients within the VQI’s TCAR Surveillance Project (TSP). This decision is effective immediately.

On May 2, Silk Road announced FDA approval for expanded indications for the company’s Enroute transcarotid stent system to include patients at high risk and standard risk for adverse events from carotid endarterectomy (CEA).

Silk Road stated that the SVS VQI TSP is a prospective, national, open-ended observational registry designed to monitor the safety and effectiveness of transcarotid stents placed directly into the carotid artery while reversing blood flow within the carotid artery to reduce stroke risk.

Hospitals and physicians participating in the TSP can obtain reimbursement for TCAR procedures by submitting claims under the National Clinical Trial number: NCT02850588. Reimbursement for TCAR within the TSP will now apply to Medicare beneficiaries who are deemed to be at high risk and standard risk for adverse events from CEA, advised the company.

“With substantial real-world evidence of over 45,000 procedures performed to date with compelling clinical and patient benefits, TCAR has become the less-invasive standard in stroke prevention treatment options,” commented Sumaira Macdonald, MD, Executive Medical Director of Silk Road Medical. “The expanded coverage and access are encouraging for patients looking for a reliable, minimally invasive treatment option for carotid disease regardless of their surgical risk classification.”

According to Silk Road, TCAR combines surgical principles of neuroprotection with endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. TCAR with the Enroute transcarotid stent is intended to be used in patients at high risk and standard risk for adverse events from CEA in conjunction with the Enroute transcarotid neuroprotection system (NPS). The Enroute transcarotid NPS is 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, stated the company.