Silk Road Medical disclosed encouraging new clinical data for its Enroute device, which is cleared to help protect the brain from stroke while implanting a transcarotid artery stent.
The company said that additional data showed its Enroute transcarotid neuroprotection and stent system, indicated for transcarotid artery revascularization (TCAR), helped improve stroke and death rates in the wake of its FDA sign-off last October. Investigators from Massachusetts 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.
“The robust evidence base continues to build for TCAR as a compelling alternative to both carotid endarterectomy and transfemoral carotid artery stenting,” Silk Road Medical Chief Medical Officer Sumaira Mcdonald said in prepared remarks. “With such low peri-procedural stroke rates and the benefit of a less invasive approach, TCAR has the clear potential to be a standard of care in the treatment of carotid artery disease.”
– Researchers reported a 30-day stroke and death rates of 2.8%, 1.3% and 2.3% in the Pivotal, Continued Access and combined cohort portions of its ROADSTER trial, which featured high surgical risk patients. They noted that the combined outcomes in high surgical risk patients for the testing were much better than high surgical risk patients treated with conventional carotid endarterectomy.
– One-year follow-up data of 50 patients who had a TCAR procedure revealed the stent remained effective and there was a stroke free survival rate of 100%. These patients also displayed no strokes at 30 days.
– Another presentation focused on 28 patients who had the Enroute system implemented as part of the ROADSTER trial. Data from this group reinforced the idea that temporary reversal of blood flow, as the Enroute system does, is safe, and can minimize the risk of blood clots without causing a stroke.
Last October, Silk Road Medical 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.