Medtronic ATHENA Heli-FX China Clinical Trial Investigator Meeting Held in Beijing

Beijing Anzhen Hospital, Capital Medical UniversityProf. Zhong ChenAs the Principal Investigator of the lead center for this clinical trial, he delivered an in-depth analysis of clinical challenges and the product's value in his opening remarks. He pointed out that the Heli-FX product has long attracted significant international attention. Although early concerns existed regarding potential vascular wall injury or effects on adjacent organs, comprehensive clinical data have confirmed its excellent safety and efficacy. This year, Medtronic signed a strategic cooperation agreement with the Beijing Municipal Government, and this clinical trial serves as one of the key initiatives implemented by Beijing Anzhen Hospital to advance this partnership. Professor Chen Zhong emphasized that the Heli-FX EndoAnchor System provides a straightforward and highly effective treatment option for patients with complex aneurysm necks (such as angulated or conical necks) or those experiencing late-onset endoleaks. He expressed his hope that robust clinical data from China will add a powerful "weapon" to future EVAR procedures, ultimately benefiting a broad patient population.

Vice President, Structural Heart, Aortic & Peripheral Vascular Health Business, Medtronic ChinaMs. Huang FangOn behalf of the business team, she expressed sincere gratitude to all participating experts. She reviewed the project's launch last year, which was witnessed by Professor Chen Zhong, Professor Fu Weiguo, and Professor Guo Wei, and highlighted the background behind the deepened cooperation between Medtronic and the Beijing Municipal Government. This clinical study holds a central position in the strategic partnership established between the two parties during the China Development Forum this spring, and has received dedicated liaison support and strong backing from the Beijing Municipal Health Commission and Beijing Anzhen Hospital. Ms. Huang Fang stated that the business team will fully ensure the project's advancement, aiming to complete the study to the highest standards and with maximum efficiency, so that these innovative products can benefit patients in China at the earliest possible opportunity.

Medtronic Director of Clinical Research and Medical SciencesMs. Shuangshuang ChengShe then delivered an in-depth presentation from the perspectives of project implementation and quality control. She noted that the Chinese team’s ability to stand out in the global competition and secure the project was attributable to China’s top-tier expert team, abundant clinical case resources, and highly efficient and professional operational mechanisms. Ms. Cheng Shuangshuang particularly emphasized the principle that “quality control and patient safety are paramount.” She proudly revealed that over the past three years, Medtronic has undergone multiple rigorous internal and external quality audits, all of which were successfully passed on the first attempt with “zero findings.” This exemplary quality control record serves as the strongest validation for the high-standard execution of the ATHENA study, aiming to showcase high-quality local clinical data on the global academic stage with “China speed” and “international standards.”

A representative from Medtronic stated that this project has established an integrated implementation support system centered on evidence-based research development and clinical technology assurance. Strictly adhering to evidence-based medicine principles and compliance requirements, the project has completed the design of scientific research protocols and the establishment of an evaluation framework, while defining standardized implementation pathways and rollout schedules to ensure the standardized and orderly conduct of clinical research. Furthermore, the company has established an end-to-end technical training and quality control system. Leveraging standardized theoretical instruction, immersive hands-on training, expert technical support, and a tiered training model, the system comprehensively ensures the safe and standardized clinical application of innovative technologies.

During the discussion session, experts from participating centers engaged in in-depth exchanges grounded in clinical practice and project requirements, focusing on core issues such as operational standards, workflow optimization, and the management of clinical challenges. Participants thoroughly addressed questions, reached consensus on clinical execution protocols, and refined implementation workflows. These efforts effectively resolved critical issues in project advancement, laying a solid clinical foundation for subsequent standardized and large-scale implementation.

As the meeting drew to a close, Co-Principal Investigator of this clinical trial, Zhongshan Hospital, Fudan UniversityProfessor Fu WeiguoDeliver the closing address.

Prof. Weiguo FuFirst, regarding theProf. Chen ZhongAs the head of China's core vascular surgery aortic team, he expressed his sincere gratitude. He specifically noted: "This is a gathering of China's top aortic experts, and it is also, with the support of Medtronic Global, atMs. Huang Fang's Team...a highly significant international research project secured under the guidance of. Medtronic’s products have long been renowned for their ‘durability and long-term reliability’. How to sustain clinical benefits over the long term is our shared objective. I believe the Heli-FX system will continue to build on this strength, delivering more enduring benefits to patients.”

Gathering strength for long-term progress, we set sail today. The successful convening of the ATHENA Heli-FX China Clinical Trial Investigators' Meeting serves not only as a comprehensive mobilization for the study protocol, but also as a clarion call for China's endovascular aortic treatment technology to scale new heights. From stringent quality control standards to robust technical support, we have every reason to believe that,`Heli-FX Endovascular Anchoring System`Under the expert guidance of Chinese specialists, high-quality, evidence-based outcomes with global impact will be delivered. This journal will continue to track the latest progress of the ATHENA study, and together with our peers in the field, witness the full dawn of the "active anchoring" era in aortic interventions!