Shanghai, China – March 13, 2026 – Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (“Endovastec™”) recently announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Hector™ Multi-Branch Thoracic Stent Graft System (“Hector™”), an investigational device designed for the endovascular treatment of complex aortic arch disease.
The FDA Breakthrough Devices Program is intended to facilitate development and review of medical devices that may provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The designation provides opportunities for early and frequent interaction with the FDA as development progresses.
Complex aortic arch disease remains one of the most challenging areas in endovascular therapy. Patients with disease involving the aortic arch and its three supra-aortic branches face limited treatment options as the complex anatomy makes traditional surgical and endovascular treatments less suitable1. Complete endovascular reconstruction of the aortic arch, including all three supra-aortic branches, remains a significant clinical challenge. A multi-branched endograft that enables complete single-stage endovascular reconstruction could address this unmet clinical need.
Hector™ is Endovastec™’s investigational triple-branched thoracic stent graft system developed to support endovascular reconstruction of the aortic arch and all three supra-aortic branches. The system builds upon extensive experience in aortic innovation and the company’s prior branched platform technologies. It reflects Endovastec™’s ongoing focus on advancing aortic technologies for complex disease states and expanding treatment possibilities for patients who may benefit from less invasive approaches.
“The FDA’s Breakthrough Device Designation highlights the seriousness of complex aortic arch disease and the continued need for new endovascular treatment approaches,” said Qing Zhu, PhD, President of Endovastec™. “This designation is an important milestone in the development of Hector™, and we look forward to continued engagement with the FDA as we advance the program.”
“Complete endovascular reconstruction of the aortic arch with all three supra-aortic branches remains an important unmet need in cardiovascular care. Breakthrough Device Designation provides a valuable framework for interaction with the FDA as clinical evidence is generated to evaluate the safety and effectiveness of Hector™ in this high-risk patient population.” said Brian Y. Chang, MD, PhD, Chief Medical Officer of MicroPort®.
In addition to progress in the U.S., Hector™ was admitted in March 2025 into China’s Green Channel for Innovative Medical Devices, which supports prioritized regulatory review for qualified products. Hector™ has also entered clinical application in selected international markets, including Egypt, Singapore, and Malaysia, as part of Endovastec™’s broader global clinical and regulatory development strategy.
Receipt of Breakthrough Device Designation does not constitute FDA approval or clearance for commercial distribution in the United States. Hector™ remains an investigational device.
About Endovastec™
Founded in 2012, Endovastec™ (Shanghai MicroPort Endovascular MedTech Group Co., Ltd.; SSE: 688016), an associated company of MicroPort® (MicroPort Scientific Corporation, HKEX: 00853), is a global medical device company focusing on the research, development, manufacturing, and commercialization of aortic and peripheral vascular interventional devices.
Endovastec™'s product portfolio includes thoracic and abdominal aortic stent grafts, stent grafts for surgical applications, peripheral vascular stents, and drug-coated PTA balloon catheters. The company is committed to advancing emerging technologies in great vessel surgery and peripheral vascular medicine and to providing access to state-of-the-art solutions for patients worldwide.
For more information, please visit: www.endovastec.com/en
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