Sahajanand Medical Technologies recently received full reimbursement confirmation in France for its Supraflex Cruz heart stent.
The Ministry of Health and Public Affairs of France conducted a scientific review for reimbursement. The clinical data the heart stent was evaluated for safety and applicability to France’s population. Reimbursement approval is based on positive clinical data from a trial of patients with ischemic coronary artery disease.
“We have been honored and happy to be the first center to implant the new ultrathin (60 microns) Supraflex Cruz coronary stent in France recently. The initial experience with Cruz has been good with 100% procedure success. We have tested it in 20 patients, some were complex tortuous lesions and we found the product at par with others with excellent deliverability,” Marc Silvestri, an interventional cardiologist in Aix en Provence, France, said in a news release.
Supraflex Cruz features low strut thickness (60 μm) and a biodegradable polymer in a number of size matrices.
“We are happy to receive the approval from the French authorities,” SMT VP of regulatory projects Ammad Shorabji said in a news release. “Success of Supraflex and Supraflex Cruz reimbursement is the validation of robustness of the quality standards and the clinical data of SMT products which are at par with the global standards.”