June 24, 2020

SMT’s Supraflex Cruz Heart Stent Approved for National Reimbursement in France

June 24, 2020—Sahajanand Medical Technologies Pvt Ltd. (SMT), based in Mumbai, India, announced it has received the full reimbursement confirmation for its Supraflex and Supraflex Cruz coronary heart stents from the Ministry of Health and Public Affairs of France. Both devices have received price approval on par with other advanced drug-eluting stents, advised the company. In July 2019, the company announced European CE Mark approval for the Supraflex Cruz.

According to the SMT, the reimbursement approval comes after a rigorous two-step scientific review process conducted by the French Medical Device and Health Technology Evaluation Committee. The committee evaluated the clinical data from the TALENT all-comers trial for the product’s safety and its applicability to the population of France. TALENT is a prospective, multicenter, randomized controlled clinical trial composed entirely of European-based patients with ischemic coronary artery disease. The TALENT all-comers results were published in March 2019 in The Lancet (2019;393:987-997).

“We have been honored and happy to be the first center to implant the new ultrathin (60 μm) Supraflex Cruz coronary stent in France recently,” commented Marc Silvestri, MD, an interventional cardiologist from Aix en Provence, France, in the SMT announcement. “The initial experience with Cruz has been good, with 100% procedure success. We have tested it in 20 patients (some [with] complex tortuous lesions), and we found the product at par with others, with excellent deliverability. The stent was challenged with a lot of direct stenting, with very promising performance even with long stents (48 mm in a right coronary artery). The stent’s implantation and deployment were easy and perfectly apposed without any recoil or foreshortening.”

Dr. Silvestri continued, “This new technology is a good addition for the French physicians, and patients will benefit [from] the latest technology now available, approved, and reimbursed by the French health authority.”


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PreCardia’s System to Treat Acute Decompensated Heart Failure Granted FDA Breakthrough Device Designation