Biosensors gains CE mark approval for BioFreedom Ultra stent system

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Biosensors has announced the award of a CE mark for BioFreedom Ultra drug-coated coronary stent system. BioFreedom Ultra is a novel thin strut (84µm) CoCr polymer and carrier-free drug-coated stent with Biosensors’ proprietary Biolimus A9 drug. BA9 is Biosensors’ proprietary highly lipophilic anti-restenotic drug, developed specifically for use in coronary vascular applications. 

The BioFreedom Ultra stent will optimise the percutaneous coronary intervention (PCI) procedure for high bleeding risk (HBR) patients by simplifying stent choice pre-procedure based on the LEADERS FREE legacy, enhancing procedure success thanks to the stent design and maximising outcomes for HBR patients treated with one-month DAPT, Biosensors said in a press release.

The LEADERS FREE III trial enrolled 400 HBR patients at 18 sites, using the same inclusion criteria as the LEADERS FREE randomised trial. LEADERS FREE III is a single arm trial with all patients being 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 and the primary efficacy endpoint was clinically driven target lesion revascularisation. BioFreedom Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at one year in this high bleeding risk population was only 1%.

LEADERS FREE III adds to the wealth of safety and efficacy evidence for the use of the BioFreedom stent with a one-month duration of DAPT. The trial programme LEADERS FREE, LEADERS FREE JAPAN, LEADERS FREE II and LEADERS FREE III now includes more than 4,000. LEADERS FREE showed that the safety and efficacy benefits are maintained at two years and the LEADERS FREE ACS subgroup had a significant reduction in cardiac death.

Biosensors chief medical officer Keith G Oldroyd, said: “Biosensors are looking forward to further increasing their interventional cardiovascular portfolio by making another Biolimus A9-eluting device available for the treatment of patients with coronary artery disease. In addition, and as a testament to our commitment to making new treatment options available to our clinicians and their patients, Biosensors parent company have expanded into the rapidly growing field of structural heart disease intervention through the acquisition of New Valve Technology, the developers of the Allegra TAVI [transcatheter aortic valve implantation] device.”


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