October 19, 2020
Biosensors’ BioFreedom Ultra CoCr DES Receives CE Mark Approval
October 19, 2020—Biosensors International Group Ltd announced European CE Mark approval for the company’s new BioFreedom Ultra drug-coated coronary stent system.
According to the company, BioFreedom Ultra is a thin strut (84 μmβ), cobalt-chromium polymer, carrier-free drug-coated stent with Biolimus A9 drug, the company’s highly lipophilic antirestenotic drug developed for use in coronary vascular applications. The BioFreedom Ultra stent is intended for percutaneous coronary intervention for high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy.
Approval was supported by the LEADERS FREE III trial, which enrolled 400 HBR patients at 18 sites using the same inclusion criteria as the LEADERS FREE randomized trial. LEADERS FREE III is a single-arm trial, with all patients treated using the BioFreedom Ultra device. The data was compared to the BioFreedom stainless steel drug-coated stent (DCS-StS) and bare-metal stent (BMS) groups from LEADERS FREE. The primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.
The study found that the BioFreedom Ultra was noninferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at 1 year in this HBR population was only 1%.
The BioFreedom Ultra device is not available in the United States and any other country where applicable health authority product registration has not been obtained, advised the company.