Terumo and MicroVention’s Roadsaver Dual-Layer Micromesh Carotid Stent Receives Reimbursement Approval in France

June 29, 2021—Terumo France/Europe and MicroVention Europe announced the reimbursement approval for the Roadsaver carotid stent system in France after receiving a positive assessment from the French National Authority for Health, which highlighted a therapeutic benefit of the device.

The Roadsaver system is manufactured by MicroVention Europe and distributed by Terumo Europe NV.

According to the companies, the reimbursement was granted based on clinical evidence supporting the safety and performance of Roadsaver in both symptomatic and asymptomatic patients, including the interim analysis of a large ROADSAVER observational study, which is currently being conducted at 52 sites in 13 European countries with approximately 2,000 patients enrolled.

The companies advised that the Roadsaver dual-layer micromesh carotid stent’s approved indication is the same as for the previously approved single-layer platforms. It includes the treatment of symptomatic atherosclerosis when endarterectomy is not an option or exceptionally in asymptomatic patients.

The next-generation device is designed to prevent plaque protrusion through the struts and provide a sustained embolic protection. It incorporates a flexible, nitinol, dual-layer micromesh platform. The low crossing profile (5 F) allows for easy stent delivery in complex anatomies and is compatible with a transradial approach, stated the companies.

“This decision bears out the wisdom of our strategy in the adoption of this technology since its availability in France,” commented interventional cardiologist Max Amor, MD, in the companies’ press release. “We are glad now [that] more carotid patients will have access to Roadsaver, with its advanced design that provides a sustained embolic protection also after the procedure.” Dr. Amor is Director of the Cardiovascular Department at Clinic Louis Pasteur in Essey-Lès-Nancy, France.

Koen Deloose, MD, who is Director of ID3 Medical and Head of the Department of Vascular Surgery, AZ Sint Blasius Hospital in Dendermonde, Belgium, added, “The Roadsaver dual-layer micromesh stent is considered a valuable alternative for open surgery in selected patients based on its safety and efficacy profile, proven in an extended clinical program.”