Biosensors BioFreedom DCS Devices Approved in United States and Japan

May 3, 2022—Biosensors International Group, Ltd. announced FDA approval for the polymer-free and carrier-free BioFreedom drug-coated stent (DCS) in the United States and approval by the Pharmaceuticals and Medical Devices Agency in Japan of the BioFreedom Ultra DCS for percutaneous coronary intervention (PCI). BioFreedom is the company’s first stent product to be approved in all the major key markets globally, as well as in many other country-specific registrations across the world.

According to the company, the BioFreedom devices feature the company’s Biolimus A9 (BA9) limus drug. BA9 is a highly lipophilic antirestenotic drug, developed specifically for use in coronary vascular applications. BioFreedom Ultra also features thin (84 μm) cobalt chromium struts.

In the United States, BioFreedom allows for 1-month dual antiplatelet therapy in patients post-PCI who are at high risk of bleeding (HBR). The BioFreedom stent systems optimize the PCI procedure for HBR patients by simplifying stent choice preprocedure based on the LEADERS FREE randomized trial program, which included 2,500 HBR patients. Additionally, the LEADERS FREE II trial enrolled 1,203 HBR patients at 66 sites in the United State and Europe, using the same inclusion criteria as the LEADERS FREE trial.

Biosensors reported that in the single-arm LEADERS FREE II trial, all patients were treated using BioFreedom and the control was the bare-metal stent (BMS) arm of LEADERS FREE trial. The primary safety endpoint of the trial was a composite of cardiac death and myocardial infarction. The primary efficacy endpoint was clinically driven target lesion revascularization.

In LEADERS FREE II, BioFreedom DCS compared to BMS was both significantly safer (9.3% vs 12.4%; hazard ratio [HR], 0.72; 95% CI, 0.55-0.94; P = .0150 for superiority) and significantly more efficacious (7.2% vs 9.2%; HR, 0.72; 95% CI, 0.52-0.98; P = .0338 for superiority) than the BMS at 1 year, in this previously understudied North American HBR patient population, stated the company.

In October 2015, findings from the LEADERS FREE study were presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation and were published in The New England Journal of Medicine. (2015; 373:2038-2047).

In September 2018, the company announced that the primary endpoint results of the LEADERS FREE II trial were presented by Mitchell W. Krucoff, MD, at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium.