Shanghai, China, 11 November 2021 - The Vflower™ Venous Stent System (Vflower™), developed by Shanghai Bluevastec MedTech Co., Ltd. (Bluevastec™), has been given access by the National Medical Products Administration (NMPA) of China to enter the ‘Green Path’, the special approval procedure for innovative medical devices. This marks a total of 25 products by MicroPort® or affiliated companies that have entered the Green Path, 6 of which were developed by Endovastec™.
Unlike conventional braided stents, Vflower™ features three disruptive designs. First, its unibody design with a combination of dense and sparse cells provides support and flexibility, which not only addresses compression in the iliofemoral veins, but also ensures conformity to the physiology of the iliac veins. Second, in response to the varying diameters of iliofemoral veins, Vflower™ provides physicians with more options through a variable diameter stent that can meet individual needs. In addition, Vflower™’s delivery system is designed to compensate for stent foreshortening. The device offers a post-release mechanism, which helps to solve braided stents’ pain points as a result of inaccurate positioning during release, thus enabling precise positioning and effective lesion coverage.
Qing Zhu, President of Endovastec™, stated, "There is a very promising market for venous products, however, there are currently only two venous stents available on the Chinese market. The approval of the Vflower™ Venous Stent System to enter the Green Path will accelerate its market launch process in China. This is of great significance in our effort to speed up research and innovation, promote the localization of premium medical devices and benefit more patients with peripheral vascular diseases.”
After the first subject was enrolled in November 2020, the pre-market clinical trial of Vflower™ completed subject enrollment in September 2021, thanks to the collaboration of several clinical centers across China. The trial has seen a 100% success rate in terms of device, technical and procedural success. Follow-up results show that Vflower™ is recognized by expert teams for its superior performance and treatment results in both the medium and long term.
Iliac Venous Compression Syndrome (IVCS) is a condition in which compression in the iliofemoral vein causes the stasis of blood in lower extremity veins. Mainstream treatments for IVCS include balloon angioplasty and stent implantation. Compared with balloon angioplasty, which is likely to result in elastic retraction and restenosis, an implanted stent provides continuous support of the stenotic lesion and has a higher patency rate in the medium to long term.
Shanghai Bluevastec MedTech Co., Ltd. is a wholly-owned subsidiary of Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™, stock code: 688016.SH). In addition to the Vflower™, Bluevastec™ has also received type test reports for two other products - a venous thrombectomy system and a vena cava filter. These are expected to enter the clinical stage in 2022. With this as a new grounding in the field of peripheral veins, Endovastec™ and its subsidiary Bluevastec™ will continue to innovate and upgrade the performance of their core products, and remain committed to providing patients with inclusive and holistic total medical solutions for treating venous diseases.