Bluesail Medical’s New Generation of Biofreedom ™ Ultra Cobalt-Chromium Alloy Stent Obtained CE Certification


Recently, Bluesail Medical received the CE certificate of the cobalt-chromium alloy second-generation upgraded coronary stent BioFreedom™ Ultra from DEKRA Certification BV, which means that Bluesail Medical’s new cobalt-chromium alloy BioFreedom™ Ultra will be launched in Europe. This product, together with the Biomatrix Alpha stent that was launched in Europe earlier, will provide European patients with a more diverse selection of cardiovascular products.

BioFreedom™ is the world’s first polymer-free drug-eluting stent developed by Bluesail Medical’s cardio-cerebrovascular division. It is a star product whose effectiveness and safety have been verified by many clinical trials. The product adopts Selectively Micro-Structured Surface (SMS), which increases the contact area between the stent and the blood vessel, and makes the drug release more uniform, allowing the patented drug BA9 to be directly attached to the microstructure surface without a drug carrier. Highly selective release of drugs to the blocked coronary artery wall. Polymers or other carriers are not needed during the treatment process, which can avoid the long-term adverse effects of polymers/carriers on the blood vessels and shorten the dual antiplatelet therapy (DAPT) cycle to one Month, improved the safety and effectiveness of coronary artery treatment.

In the field of high bleeding patients and short DAPT, the BioFreedom stent has always been a benchmark product in the industry. The large-scale randomized controlled trial of the device giant Medtronic in this field uses the BioFreedom stent as a standard control product. Bluesail Medical’s BioFreedom™ Ultra to be launched in Europe is an upgraded version of BioFreedom™. It is made of (84µm) cobalt-chromium alloy material. It also uses Biolimus A9™, the patented drug of Biolimus A9™, as the carrier-free drug-coated stent. The lipophilicity reaches normal More than 10 times the drug, it can significantly inhibit the proliferation of vascular smooth muscle cells and effectively reduce the rate of restenosis after percutaneous coronary intervention (PCI).

The Leaders Free series of clinical trials led by Parkson International is currently the most complete clinical trial for the selection of PCI treatment equipment for patients with high bleeding risk and the design and implementation of subsequent antiplatelet drug programs. At the same time, the test results also provide treatment for patients with high bleeding. The most important clinical basis.

The LEADERS FREE III trial was carried out on the new generation of Biofreedom™ Ultra stents, which proved that the safety and effectiveness of the second generation of Biofreedom are higher than that of stainless steel drug-coated stents and bare metal stents. Biofreedom™ Ultra focuses on the clinical needs of patients with high bleeding risk. It can cover a wide range of patients with high bleeding risk and complicated conditions. The postoperative dual antiplatelet therapy (DAPT) time is short, and it can maintain high bleeding in the short term compared to other companies’ products. Leading advantage among at-risk patients.

Since the acquisition of Baisheng International in 2018, Bluesail Medical has embarked on the road of development from low- and medium-value consumables to high-value consumables. Through the synergistic development of endogenous and epitaxy, it quickly integrates domestic and foreign technical research and development capabilities, and carries out product innovation and creation. . In the cardio-cerebrovascular sector, from the upgrade of coronary stent products to the acquisition of the German valve star enterprise NVT, to enter the field of structural heart disease; from the investment in the world’s second largest magnetic levitation artificial heart in the field of heart failure to the development of new neuro and peripheral interventional products In research and development, Bluesail Medical has formed a total cardio-cerebrovascular solution in the cardio-cerebrovascular plate, covering four product lines of coronary intervention products, structural heart disease products, peripheral vascular intervention products and neurovascular intervention products.

The new generation of cobalt-chromium alloy coronary stent BioFreedom™ Ultra is undoubtedly another blockbuster product. It is a new milestone for stent products for patients with high bleeding risk, and it also brings more gospels and choices for patients with coronary heart disease. It is expected that the launch of BioFreedom™ Ultra in Europe will also increase Bluesail Medical’s overall revenue in the European market.


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