The Roadsaver carotid stent system (Terumo France/Europe and MicroVention Europe) has been reimbursed in France. This follows the positive assessment from the French National Authority for Health (HAS), which highlighted a therapeutic benefit of the device.
“This decision bears out the wisdom of our strategy in the adoption of this technology since its availability in France,” says interventional cardiologist Max Amore (Clinic Louis Pasteur, Essey-Lès-Nancy, France). “We are glad that, now, more carotid patients will have access to Roadsaver, with its advanced design that provides a sustained embolic protection, [and] also after the procedure”.
This is the first dual-layer micromesh carotid stent to be approved by HAS and to be added to the list of reimbursed medical products (LPPR). The approved indication for Roadsaver 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 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 programme,” comments Koen Deloose, director of ID3 Medical and head of the Department of Vascular Surgery at AZ Sint Blasius Hospital, Dendermonde, Belgium.
Terumo’s Roadsaver carotid artery stent system is designed to prevent a plaque protrusion through the struts and provide a sustained embolic protection, a press release explains. Its design incorporates a flexible nickel-titanium (Nitinol) dual-layer micromesh platform. Low crossing 5F profile allows for easy stent delivery in complex anatomies and is compatible with trans-radial approach.
Ghada Farah, SVP of Terumo Interventional Systems EMEA, adds: “We are delighted with this approval, which makes double layer micromesh stents available to all hospitals in France and confirms the robustness of our Roadsaver European registry data, the largest Carotid Artery stenting study in Europe”.
This reimbursement has been granted based on clinical evidence supporting the good safety and performance of Roadsaver carotid artery stent system in both symptomatic and asymptomatic patients, including the interim analysis of a large ROADSAVER observational study, currently being conducted in 13 European countries (52 sites) on about 2,000 patients enrolled.