Blue Sail Medical's Next-Gen BioFreedom™ Ultra Cobalt-Chromium Coronary Stent Receives CE Certification

Recently, Bluesail Medical received the CE certificate for its second-generation upgraded cobalt-chromium alloy coronary stent, BioFreedom™ Ultra, issued by the notified body DEKRA Certification B.V. This signifies that Bluesail Medical’s new product, the cobalt-chromium alloy BioFreedom™ Ultra, is poised for launch in the European market. Together with the Biomatrix Alpha stent, which was previously launched in Europe, this product will provide European patients with a more diverse range of cardiovascular treatment options.

Biofreedom™ Ultra Cobalt-Chromium Stent

BioFreedom™ is the world’s first polymer-free drug-eluting stent developed by Biosensors International, the cardiovascular and cerebrovascular division of Bluesail Medical. It is a flagship product whose efficacy and safety have been validated through multiple clinical studies. The product utilizes Selectively Micro-Structured Surface (SMS) technology, which increases the contact area between the stent and the vessel wall, enabling more uniform and consistent drug release. This technology allows the proprietary drug BA9 to adhere directly to the micro-structured surface without requiring a drug carrier, facilitating highly selective drug delivery to the walls of coronary arteries obstructed by lesions. By eliminating the need for polymers or other carriers during treatment, it avoids the potential long-term adverse effects of polymers/carriers on blood vessels, shortens the duration of dual antiplatelet therapy (DAPT) to one month, and enhances the safety and efficacy of coronary intervention.

In the field of short dual antiplatelet therapy (DAPT) for patients at high bleeding risk, the BioFreedom stent has long been the industry benchmark. Large-scale randomized controlled trials conducted by medical device giant Medtronic in this area have used the BioFreedom stent as the standard control product. The BioFreedom™ Ultra, an upgraded version of the BioFreedom™ soon to be launched in Europe by Bluesail Medical, is made of cobalt-chromium alloy with a strut thickness of 84 µm. Like other carrier-free drug-coated stents, it utilizes Biosensors International’s patented drug, Biolimus A9™, which exhibits lipophilicity more than ten times greater than that of conventional drugs. This significantly inhibits vascular smooth muscle cell proliferation and effectively reduces the rate of restenosis following percutaneous coronary intervention (PCI).

The Leaders Free series of clinical trials, led by Biosensors International, represents the most comprehensive clinical evaluation to date regarding the selection of percutaneous coronary intervention (PCI) devices and the design and implementation of subsequent antiplatelet therapy regimens for patients at high bleeding risk. Furthermore, the trial results provide the most critical clinical evidence for the management of high-bleeding-risk patients.

The next-generation Biofreedom™ Ultra stent was evaluated in the LEADERS FREE III trial, which demonstrated that the second-generation Biofreedom has superior safety and efficacy compared to stainless steel drug-coated stents and bare-metal stents. The Biofreedom™ Ultra is designed to address the clinical needs of patients at high bleeding risk (HBR), covering a broad spectrum of HBR patients with complex conditions. It allows for a shorter duration of dual antiplatelet therapy (DAPT) post-procedure, thereby maintaining a competitive advantage over other companies’ products in the management of HBR patients in the short term.

Since its acquisition of Biosensors International in 2018, Bluesail Medical has embarked on a development path from low- and medium-value consumables to high-value consumables. By synergizing organic growth with external expansion, the company has rapidly integrated domestic and international R&D capabilities to drive product innovation and creation. In the cardiovascular and cerebrovascular sector, Bluesail Medical has advanced from the upgrading and iteration of coronary stent products to entering the field of structural heart disease through the acquisition of NVT, a leading German valve company. Additionally, the company has expanded into the heart failure domain by investing in the world’s second-largest fully magnetically levitated artificial heart developer, while also advancing the R&D of new neurovascular and peripheral intervention products. Bluesail Medical has thus established a comprehensive solution for cardiovascular and cerebrovascular conditions, with a portfolio spanning four product lines: coronary intervention products, structural heart disease products, peripheral vascular intervention products, and neurovascular intervention products.

The new-generation cobalt-chromium alloy coronary stent, BioFreedom™ Ultra, is undoubtedly another blockbuster product. It marks a new milestone in stent solutions for patients at high bleeding risk and brings greater benefits and more options to patients with coronary heart disease. The launch of BioFreedom™ Ultra in Europe is expected to provide strong momentum for Bluesail Medical’s overall revenue growth in the European market.