PARIS, FRANCE - June 29, 2021 - Terumo France/Europe and MicroVention Europe welcome the reimbursement of the RoadsaverTM 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 RoadsaverTM 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 RoadsaverTM 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 RoadsaverTM 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 RoadsaverTM 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 RoadsaverTM 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.
- HAS publication April 2021
- A novel carotid stent for sustained embolic protection, Subbarao Myla, Newport Beach, USA, Presentation CIRSE 14.-18.September 2013, Barcelona, Spain.
- ● Bosiers et al. Evaluation of a new dual-layer micromesh stent system for the carotid artery: 12-month results from theCLEAR-ROAD 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.
Roadsaver™ Carotid Stent System is indicated for use in patients with carotid arterial atherosclerotic disease. Roadsaver™ Carotid Stent System is manufactured by MicroVention Europe and distributed by Terumo Europe N.V.
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About Terumo Europe
Terumo Europe is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Medical Products, Cardiovascular Products and Diabetes Management. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA. www.terumo-europe.com
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.