Fontus™ System of Endovastec™ Approved for Marketing by NMPA

Shanghai, China, 20 December – Recently, the Fontus™ Branched Surgical Stent Graft System (Fontus™), developed by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™), received approval for marketing by China’s National Medical Products Administration (NMPA). This milestone marks Endovastec™’s 12th product to achieve NMPA approval since its establishment in 2012. In 2015, Fontus™ was selected for the Shanghai Industry-University-Research Special project in 2015, and was subsequently approved to enter the special approval process of NMPA for innovative medical devices in 2018.

Fontus™ is the next generation of Endovastec™’s CRONUS™ Stent Graft System (CRONUS™). Compared with CRONUS™, Fontus™ has a unique single-branch structure that effectively avoids deep dissociation and anastomosis of the left subclavian artery, significantly simplifying the procedure. Its collagen-coated vascular graft at the proximal end of the main body has a maximum length of 100 mm, making it fit for diversified operations. The main body, which can be up to 200 mm, uses a separate Nitinol stent segment for better flexibility, giving doctors more options for use. Furthermore, it boasts an integrated design of the delivery system, independent control of the main body and branch of accurate release.

The management of acute Standford type A aortic dissection is a major challenge in the field of aortic surgery. Currently, the main treatment is Sun's surgery in China, which is the combination of aortic total arch replacement and elephant trunk stent. However, this procedure can easily cause vascular and nerve damage during the dissociation and reconstruction of the left subclavian artery. Due to the deep dissection of the aorta, it is more difficult to anastomosis, increasing the risk of bleeding and internal environment disorder. Fontus™ has a unique single-branch structure that effectively avoids deep dissociation and anastomosis of the left subclavian artery, significantly simplifying this procedure. The 1-year clinical follow-up data of Fontus™ showed that compared with CRONUS™, the integrated branch design of Fontus™ significantly shortened the time of left vertebral ischemia and cerebral perfusion, reducing the incidence of brain injury and neurological complications.

Mr. Qing Zhu, President of Endovastec™, commented, "From the only surgical stent graft system in China, CRONUS™, to the first branched surgical stent graft system globally, Fontus™, the iterative products can reduce the difficulty of surgery, shorten the operation time, reduce postoperative complications of the nervous system and other organs, and provide a better solution for popularization of aortic dissection surgery, thus saving more patients with aortic dissection in the future.”

About Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd.

Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™), a subsidiary of MicroPort Scientific Corporation (Stock code: 00853.HK), was founded in Shanghai SIMZ Century Medicine Park in 2012. Endovastec™ was granted Shanghai High-tech Enterprises, Shanghai Science and Technology Little Giant Enterprise, and the first batch of Specialized and New “Little Giant” Enterprise, AAA-level Credit Enterprise and Multinational R&D Center in China. Endovastec™ was listed on the STAR Market (Stock code: 688016) of the Shanghai Stock Exchange on July 22, 2019.