Silk Road Medical is celebrating a positive reimbursement decision from Medicare for its transcarotid artery revascularization (TCAR) procedures. The news comes as music to Silk Road’s ears as it attempts to gain ground with its transcarotid neuroprotection and stent systems, which are used in the procedures.
The Centers for Medicare and Medicaid (CMS) expanded coverage for the company’s procedure to include patients who are being treated with an FDA-approved proximal embolic protection device and an FDA-approved carotid artery stent system. As of right now, Silk Road’s Enroute Transcarotid Neuroprotection and stent system are the only devices approved for TCAR procedures, the company said in a statement.
Patients included in the recent coverage decision also must take part in the new national TCAR Surveillance Project, a national, open-ended observational registry. The project, which is sponsored by the Society for Vascular Surgery Patient Safety Organization, already has support from the FDA, Silk Road said.
"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 transcarotid artery revascularization procedures," Silk Road CEO Erica Rogers said in a statement. "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."
Extended Medicare coverage gives Silk Road added momentum as it charges ahead with its Enroute system. Last year, the company got FDA clearance for the original device, which allows surgeons to insert a stent into an artery in the neck instead of through the groin.
Earlier this year, the Sunnyvale, CA-based company got CE mark approval for a second-generation Enroute system to treat blocked carotid arteries in the neck.
Meanwhile, Silk Road is raking in funds to support product development. In October 2015, the company announced $57 million debt and equity financing from investors including CRG, Warburg Pincus and The Vertical Group. Silk Road said that it would use the funding to commercialize Enroute in the U.S.