DragonFly™ TEER System: China's Breakthrough Solution Gains Global Recognition with Superior Performance and 3-Year Durability Data

Mitral Regurgitation (MR) is the most common heart valve disease. According to a Frost & Sullivan report, by 2027, the global prevalence of moderate to severe mitral regurgitation is expected to increase to 1.37%, with the number of patients rising to 114 million, and the disease burden will continue to grow. The condition not only causes patients to endure clinical symptoms over the long term but also inevitably progresses to heart failure. Without intervention, patients with mitral regurgitation face extremely high rates of heart failure hospitalization and mortality in the long term, making timely intervention critical.

Currently, the treatment options for mitral regurgitation are limited and have many shortcomings:Drug TherapyCan only improve symptoms, unable to extend patient survival time or improve surgical timing;Surgical OperationHigh trauma, high risk, many patients refuse surgery due to intolerance or fear of surgical risks.

Facing such therapeutic dilemmas, interventional procedures originating from surgical experience are gaining broader market application prospects due to their significant advantages, including minimal invasiveness, rapid recovery, and the ability to assess and optimize surgical outcomes in real time. Among these, Transcatheter Edge-to-Edge Repair (TEER) has become a mainstream minimally invasive treatment solution thanks to its precision repair, ease of catheterization, and flexible intervention. However, its development still faces a series of global challenges: difficulty in leaflet capture, complex device operation, and high costs caused by the monopoly of international brands.

Against this backdrop, the thirty-fifth London Valves Conference (PCR London Valves 2025) has welcomed a "game-changer" from China into the spotlight. Valgen Medtech not only unveiled the highly anticipated DragonFly™ Transcatheter Mitral Valve Clip System but also...Three-Year Long-Term Follow-Up Data, and through aLive surgical broadcast in real time,Demonstrated to the world its equivalence or even superiority to international brands.Superior PerformancePotential, providing a solid guarantee for the precision and success of TEER surgery.

To understand the attention DragonFly™ has garnered in London, one must first return to the clinical origins of TEER technology: what it requires is not just a "clip," but rather a system capable of balancingOperational Certainty, Treatment Durability, and Technological AccessibilitySystematic solution.

●Precise Anatomical Adaptation + Efficient Leaflet Capture: DragonFly™ adoptsFree-angle locking with central occlusion netThe design can balance residual regurgitation with transvalvular pressure gradient, taking into account both immediate tension and long-term stability.More flexible options are available for different anatomical structures during the operation, with the system equipped with four models of mitral valve clips., adaptable to more anatomical structures; and equipped withIndependent Capture Function, which can effectively improve the valve leaflet capture rate;

●Advantages of Full-Scale System: The full-scale system of DragonFly™ provides operators with clear guidance and feedback, not only significantly shortening the learning curve to enable more doctors to quickly master it, but also ensuring surgical efficiency and success rates through standardized operational procedures.

DragonFly™ Transcatheter Mitral Valve Clip System

Overall, DragonFly™ enables safer and more effective gripping, accommodates a wider range of patients, offers more intuitive and convenient overall operation, and delivers precise and reliable treatment outcomes.

From the solid evidence of long-term clinical data, to the precise practice of live-streamed high-difficulty surgeries, to the authoritative endorsement by top global experts, Valgen Medtech's three key achievements this time have multi-dimensionally demonstrated the strong capabilities of DragonFly™ in terms of efficacy, practical operation, and recognition, building a solid bridge for its global expansion and earning international trust.

During the conference, global valve disease expert Professor Francesco Maisano from the San Raffaele Scientific Institute released critical research data on the DragonFly™ system. Among them,For degenerative mitral regurgitation (DMR), the 3-year follow-up results of a pivotal study involving 120 Chinese patients represent a "long-term high-quality" achievement for the industry, showcasing China's innovation.

The primary efficacy endpoint analysis showed that at 36 months post-operation, 82.5% of patients with degenerative mitral regurgitation (DMR) successfully achieved the composite goal of "no death, no mitral valve reintervention, and mitral regurgitation maintained at mild or below (MR≤2+)". This meansMore than 80% of patients did not require a second surgery during long-term follow-up, with reflux effectively controlled.

DragonFly™ demonstrated excellent safety with a low incidence of adverse events. During the 36-month follow-up period, the all-cause mortality rate was only 9.2%, cardiovascular-related mortality was 7.6%, stroke incidence was 5.0%, and there were no severe device-related adverse events such as device embolization. Its safety performance surpassed the 3-year data of some international similar products.

The surgical demonstration was performed by Dr. Rodrigo Estevez-Loureiro and his team at the Álvaro Cunqueiro Hospital in Spain.

The patient is a 75-year-old male diagnosed with severe secondary mitral regurgitation, accompanied by severe left ventricular systolic dysfunction (LVEF 30%), with an STS score of 5.0%. During the procedure, Dr. Rodrigo Estevez-Loureiro's team implanted a DragonFly™ mitral valve clip in the A2-P2 region for the first time. After clipping, the regurgitation was significantly reduced, but a small amount of residual regurgitation remained on the medial side. To achieve better results, the operator applied...Unilateral Independent CaptureFunctions, and with the help ofPrecision Control of the Full-Scale Operating System, successfully capturing more posterior leaflet tissue, thereby optimizing the depth and range of leaflet engagement.

Ultimately, the team completely eliminated the prolapse lesion in the A2-P2 region using only one valve clip. Immediate postoperative ultrasound showed that mitral regurgitation decreased from severe to trace, with a transvalvular pressure gradient of 3 mmHg, marking a complete success of the surgery.

This surgical case strongly confirms from the perspective of clinical practice:DragonFly™ provides operators with stable and precise control capabilities, enabling them to flexibly adjust strategies based on actual conditions, thereby achieving better treatment outcomes.

Valgen Medtech's participation in the 35th London Valve Conference is not only a "product showcase" but also a global trust-building effort for "Chinese treatment solutions." The establishment of a complete pathway—“clinical needs–technological innovation–evidence accumulation–global validation”—has enabled Valgen Medtech to achieve the leap of "coming from Chinese clinical practice and going to global clinical practice."

Setting off from London, Valgen Medtech's globalization story has turned a new chapter.

For a long time, the global TEER market, and even the high-value medical device field, has been predominantly led by international brands. Particularly in high-end markets such as Europe and North America, domestically produced devices have struggled to break through the dual constraints of "data bias + certification barriers." However, Valgen Medtech is changing this situation with breakthroughs in clinical research, intellectual property, and technology exports. Previously, international TEER standards were mostly based on data from European and American populations and the technical pathways of international brands. DragonFly™ is the first domestically produced mitral valve treatment device to initiate and complete clinical research in Europe. Breaking through the multiple patent barriers of international giants and overcoming the notoriously stringent CE-MDR certification have allowed the "Chinese solution" to enter the global spotlight and participate in discussions on global technical standards. This has accumulated valuable experience for subsequent Chinese medical devices to engage in the construction of international rules.

Currently, Valgen Medtech's international journey is continuously accelerating: DragonFly™ has successively received approvals from regulatory authorities in Hong Kong, China; Turkey; Indonesia; Peru; Colombia; Argentina; and Vietnam.

This is not just the overseas launch of a product, but also represents a"Independent Innovation, Complete Evidence, Global Compliance"The Rise of China's High-End Medical Equipment Centered on Innovation. It demonstrates that Chinese companies can not only solve the issue of "availability" but also compete in the global high-end market and set standards based on solid technology and evidence. DragonFly™ not only offers a more adaptable Chinese approach to treating atrioventricular valve diseases globally but also drives the global TEER technology from "a single Euro-American standard" towards "multi-population compatibility," from "technological monopoly" to "diverse innovation," and from "high-end scarcity" to "universal accessibility."

At the London Valve Conference, Valgen Medtech showcased not only data and surgeries but also a development philosophy: Only by returning to the essence of clinical value, building evidence with the patience of long-termism, and participating in competition with a global perspective, can "Created in China" truly become a trustworthy choice for patients and doctors worldwide.

The road ahead remains long, but Valgen Medtech has undoubtedly proven through this appearance: In the great cause of safeguarding human heart health, Chinese strength is becoming an indispensable part.