DragonFly™ Transcatheter Mitral Valve Clip System Commences Pivotal Clinical Trial in Europe

Professor Georg Nickenig's team, Professor Scott Lim, and the Valgen team took a group photo after the surgery.

Beijing time, February 7, 2024, Valgen Medtech Co., Ltd. (referred to as "Valgen Medtech"), independently developedDragonFly™ Transcatheter Mitral Valve Clip System Successfully Completes First Confirmatory Clinical Enrollment in Europe at Universitätsklinikum Bonn, GermanyThis is another major advancement following the official approval of DragonFly™ by the National Medical Products Administration (NMPA) for market launch.Pioneering the First Chinese-produced Transcatheter Mitral Regurgitation Treatment Product in EuropeAt the same time, it is also a landmark event for Valgen Medtech to comprehensively deepen its international influence.

The surgery was primarily performed by Professor Georg Nickenig's team from the University Hospital Bonn in Germany, with on-site technical exchange provided by Professor Scott Lim from the University of Virginia Medical Center. Professor Georg Nickenig is one of the leading experts in the field of global structural heart valve interventions, with extensive experience in transcatheter treatments for mitral and tricuspid valves.DragonFly™ European Confirmatory Clinical Trial is a prospective, multicenter clinical study conducted among patients with clinical symptoms and mitral regurgitation (MR) ≥3+. The study will be carried out in major European cities.The successful completion of this surgical case will accelerate the progress of the DragonFly™ European Confirmatory Clinical Trial at other centers in Europe.

Professor Georg Nickenig's Team in Intraoperative Procedures

Professor Georg Nickenig stated post-operation: "DragonFly™ has left a deep impression on me. The entire operation process was very smooth, each step of the procedure was clear and straightforward, and it was very convenient to use. This is already my second time operating this device, and I believe that doctors in other hospitals across Europe will also be able to master and use it quickly.""I particularly appreciate the Spacer design of DragonFly™, especially those with larger Spacer specifications, which have shown unique therapeutic effects in certain special clinical cases. I look forward to subsequent clinical trials and believe it will continue to demonstrate outstanding performance."

DragonFly™ is Valgen Medtech's internationally leading product,On November 29, 2023, it was approved for marketing by the NMPA and is China's first domestically produced mitral valve clip system via the femoral vein approach. On January 25, 2024, the first implantation in China was officially completed after the product's market launch. It has currently covered regions such as Zhejiang, Henan, and Xi'an, with ongoing surgical implants being performed in newly covered medical institutions. Additionally,The company's comprehensive international quality management system can also provide保驾护航 for more innovative medical devices manufactured in China to enter the global market.

This milestone breakthrough will undoubtedly establish a brand-new image for Valgen Medtech on the global stage.Showcasing the innovative strength and determination of China's medical researchers to the world, breaking the limitations of homogenized substitution, and bringing infinite possibilities and opportunities to the entire Chinese medical technology industry.

DragonFly™ China Clinical Trial Follow-up Results Show That Patients' Cardiac Function and Quality of Life Significantly Improved 12 Months Post-surgery, Successfully Achieving the Pre-set Primary Safety Endpoint. The product’s performance demonstrates comparable results to the latest clinical trials of top overseas counterparts MitraClip and PASCAL, proving its excellent maneuverability and long-term effectiveness.

DragonFly™ entered the NMPA's "Green Channel" for innovative products in March 2021 through the Special Review Procedure for Innovative Medical Devices; in September 2023, it won the First Prize in the Vascular Category and the Second Prize in the Final of High-Value Medical Consumables at the 6th China Medical Device Innovation and Entrepreneurship Competition; and received support from the "14th Five-Year Plan" National Key R&D Program for Diagnosis and Treatment Equipment and Biomedical Materials, specifically for the project "Development of Transcatheter Mitral Valve Clip System."

DragonFly™ can achieve safer and more controllable clamping, adapt to a wider range of patients, and offer more precise and convenient overall operation, featuring four innovative designs. The central occlusion net combined with a 45-degree adjustable inner clamping angle reduces central residual regurgitation while flexibly adjusting postoperative pressure differences. Four clip sizes provide personalized adaptation for mitral regurgitation patients with various lesions and anatomical structures. Independent capture functionality allows for single-sided capture during difficult captures, improving surgical success rates and efficiency in complex cases. A visual quantitative operating system, featuring a scale knob and three-segment tube design, makes the operation more intuitive and straightforward. This provides surgeons with a better clinical experience and delivers more ideal prognostic outcomes for patients.