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Drug-coated coronary stent system receives CE mark – Med-Tech Innovation

Biosensors has received the CE Mark for BioFreedomUltra, its new drug-coated coronary stent system.

BioFreedom Ultra is Biosensors’ new, thin strut (84µm) CoCr polymer and carrier-free Drug Coated Stent with Biosensors’ 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 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.  

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 1.0%.  

Biosensors chief medical officer Prof 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 device.”   

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