Silk Road Medical said yesterday that the Centers for Medicare & Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with its Enroute transcarotid neuroprotection and stent system.
The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Sunnyvale, Calif.-based Silk Road Medical said.
The company touts the Enroute system and stent as the 1st and only devices currently approved for TCAR procedures by the FDA.
“We applaud the Society of Vascular Surgery for leading the discussions with CMS and FDA to establish this national surveillance project to provide Medicare beneficiaries access to a clinically proven, less invasive therapeutic option while broadening the real world evidence base for TCAR. We look forward to ongoing publications from this data base that support our overarching goal of reducing the morbidity and mortality associated with treating carotid artery disease,” CEO Erica Rogers said in a press release.
The reimbursement change immediately enables coverage for TCAR procedures in hospitals that are part of the Vascular Quality Initiative of the Society for Vascular Surgery’s Patient Safety Organization, Silk Road said. Reimbursement will only be applied for Medicare beneficiaries who are deemed high risk for adverse events from traditional carotid endarterectomy procedures.
In June, Silk Road released new clinical data for the Enroute device. The company said that additional data showed that the system helped improve stroke and death rates in the wake of its FDA sign-off last October.
Investigators from Mass. General Hospital and elsewhere presented their findings during the 2016 Vascular Annual Meeting of the Society for Vascular Surgery, which was held June 8-11 in National Harbor, Md.
Last October, Silk Road raised $57 million in a new equity-and-debt funding round from investors including CRG, Warburg Pincus and The Vertical Group.
The money is being used to continue a controlled U.S. launch of Enroute, fuel an international expansion and fund its ongoing registry trial, Roadster2.
