Terumo France/Europe and MicroVention Europe welcome the reimbursement of the Roadsaver^TM carotid stent system. This exciting development follows the positive assessment from the French National Authority for Health (HAS), which highlighted a therapeutic benefit of the device¹.

"This decision bears out the wisdom of our strategy in the adoption of this technology since its availability in France. We are glad now, more carotid patients will have access to Roadsaver^TM with its advanced design that provides a sustained embolic protection, also after the procedure" said Max Amor, M.D., Interventional Cardiologist, Director of the Cardiovascular Department at Clinic Louis Pasteur, Essey-Lès-Nancy, France

This is the first dual-layer micromesh carotid stent to be approved by the HAS and to be added to the list of reimbursed medical products (LPPR). The approved indication for Roadsaver^TM 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^TM 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" said Koen Deloose, M.D., Director ID3 Medical and Head of the Department of Vascular Surgery AZ Sint Blasius Hospital, Belgium

Terumo's Roadsaver^TM carotid artery stent system is the next generation carotid stent, designed to prevent a plaque protrusion through the struts and provide a sustained embolic protection². Its novel 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 added "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 a wealth of clinical evidence supporting the good safety and performance of Roadsaver^TM carotid artery stent system in both symptomatic and asymptomatic patients³, including the interim analysis of a large ROADSAVER observational study, currently being conducted in 13 European countries (52 sites) on about 2000 patients enrolled. 

 References:

1. HAS publication April 2021 

https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-6426_ROADSAVER_09_mars_2021_%20(6426)_avis.pdf

2. A novel carotid stent for sustained embolic protection, Subbarao Myla, Newport Beach, USA, Presentation CIRSE 14.-18.September 2013, Barcelona, Spain.
3. Publications

• Bosiers et al. Evaluation of a new dual-layer micromesh stent system for the carotid artery: 12-month results from the CLEAR-ROAD study. EuroIntervention. 2018 Nov 20;14(10):1144-1146. doi: 10.4244/EIJ-D-18-00230. Clear Road, Nerla, Ruffino Montorsi

• Bosiers et al. New concepts of carotid artery stenting with dual-layer micromesh stent system 30-day primary endpoint results in the CLEAR-ROAD Study. EuroIntervention. 2016 Aug 5;12(5):e671-6. doi: 10.4244/EIJY16M05_04
• Nerla et al. Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres. EuroIntervention. 2016 Aug 5;12(5):e677-83. doi: 10.4244/EIJV12I5A109.
• Kedev et al. Safety of Slender 5Fr Transradial Approach for Carotid Artery Stenting with a Novel Nitinol Double-Layer Micromesh Stent.  Am J Cardiol. 2015 Sep 15;116(6):977-81. doi: 10.1016/j.amjcard.2015.05.063. Epub 2015 Jun 25.