Biosensors International Group Ltd announces CE Mark Approval for Biolimus A9™ Coated Cobalt Chromium Coronary Stent System BioFreedom™ Ultra
16th October 2020 – Biosensors International Group Ltd (Biosensors) has announced the award of a CE Mark for BioFreedom™ Ultra, their new drug-coated coronary stent system. BioFreedom™ Ultra is Biosensors’ new, novel thin strut (84µmβ ) CoCr polymer and carrier-free Drug Coated Stent with Biosensors’ proprietary Biolimus A9™ drug. BA9™ is Biosensors’ proprietary highly lipophilic antirestenotic drug, developed specifically for use in coronary vascular applications.
The BioFreedom™ Ultra stent will optimize the PCI procedure for High Bleeding Risk (HBR) patients by simplifying stent choice pre-procedure based on the LEADERS FREE legacy, enhancing procedure successπ thanks to the stent design and maximizing outcomes1 for HBR patients treated with one month DAPT.
The LEADERS FREE III1 trial enrolled 400 HBR patients at 18 sites, using the same inclusion criteria as the LEADERS FREE2 randomized trial. LEADERS FREE III1 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 revascularization. BioFreedom™ Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at 1 year in this high bleeding risk population was only 1.0%.
LEADERS FREE III1 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 program LEADERS FREE2 , LEADERS FREE JAPAN3 , LEADERS FREE II4 and LEADERS FREE III1 now includes more than 4,000. LEADERS FREE2 showed that the safety and efficacy benefits are maintained at 2 years and the LEADERS FREE ACS5 subgroup had a significant reduction in cardiac death.
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.”
About Bluesail Medical
Bluesail Medical Co., Ltd. is a subsidiary of the Bluesail Group and represents its medical industrial arm. Founded in 2002 as a China Mainland-Hong Kong joint venture enterprise (former Shandong Blue Sail Plastic & Rubber Co., Ltd); and successfully listed on the Shenzhen Stock Exchange on April 2, 2010 (stock code 002382). Bluesail Medical has two primary business divisions: protective and sanitary products and cardiovascular and neurovascular devices. Protective and sanitary products are manufactured in Asia and Greater China region. Its sales network covers over 100 different countries and regions in North and South America, Europe, Oceania, and other regions. The products are taking up 22% of the industry’s global market share. Since 2012, Bluesail Medical has become the leading enterprise in this industry. The cardiovascular and neurovascular devices business is undertaken by its subsidiary Biosensors which was formed in 1990. Biosensors has production centers in Singapore and China. Its products are sold in over 90 countries and regions. It is the world’s top four companies engaged in the research and development, manufacturing and sales of stents business.
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