LifeTech’s G-Branch stent graft approved by China NMPA

LifeTech Scientific Corporation announced on November 6, 2025, that its G-Branch™ thoracoabdominal artery stent graft system received official registration approval from the China National Medical Products Administration (NMPA). The G-Branch™ system, developed in collaboration with Professor Guo Wei's team, is indicated for the treatment of thoracoabdominal aortic aneurysms (TAAA) involving critical visceral arteries. This approval is expected to address a significant unmet medical need, given that aortic aneurysm patients in China are projected to exceed one million by 2030, with TAAA being a particularly complex and high-risk type.

The approval follows extensive clinical evaluation, including the GUARANTEE-1 study, which enrolled 73 TAAA patients across 14 centers. This study reported a branch artery reconstruction success rate of 99.7%, a technical success rate of 95.9%, and a 12-month branch vessel patency rate of 96.7%. The overall survival rate reached 98.6%, with a 30-day post-procedural major adverse event rate of 5.5%. Subsequent GUARANTEE-2 and GUARD studies further demonstrated the device's safety and efficacy, with low rates of endoleak, aneurysmal enlargement, and stent migration, and high artery patency rates.

The G-Branch™ system is the world's first "double inner branches and double outer branches" hybrid design, enabling complete endovascular branch reconstruction. It was accepted into China's "Green Channel" for innovative medical devices in 2021. With this approval, LifeTech aims to provide a comprehensive, less traumatic, and effective solution for TAAA, further enriching its peripheral vascular intervention portfolio and solidifying its position as an innovator in endovascular aortic repair.