November 29, 2023Valgen Medtech Co., Ltd. (hereinafter referred to as "Valgen Medtech") announced its self-developed DragonFly™ Transcatheter Mitral Valve Clip System.(hereinafter referred to as "DragonFly™") has officially received approval from the National Medical Products Administration (NMPA) for market release. It is the first China-produced mitral valve clip product approved via a femoral vein approach in China.

DragonFly™ was jointly developed by Valgen Medtech in collaboration with the team led by Academician Jian'an Wang from the Second Affiliated Hospital of Zhejiang University School of Medicine and the team led by Academician Xingdong Zhang from the National Engineering Research Center for Biomaterials at Sichuan University, through nearly a decade of research efforts. It has received support from China’s "14th Five-Year Plan" key research and development program.

In China, according to the "Clinical Pathway for Transcatheter Mitral Valve Edge-to-Edge Repair in China (2022 Full Text Version)," there are approximately 7.5 million patients with MR in need of interventional treatment, and the incidence of MR significantly increases with age.The prevalence is 0.3% in the population aged 35-50, 0.9% in those aged 51-64, and 2.2% in individuals aged ≥65. The incidence of MR in moderate to severe heart valve disease among those >65 years old is as high as 19.1%. Over two-thirds of patients cannot undergo surgical treatment due to risk factors such as advanced age and comorbidities, with a 5-year mortality rate as high as 50%.

On July 23, 2020, a team led by Academician Wang Jian'an from the Second Affiliated Hospital of Zhejiang University School of Medicine successfully performed a transcatheter mitral valve repair surgery on an elderly patient using the DragonFly™ system. This marked the beginning of treating valve regurgitation in China with a domestically developed transvenous mitral valve edge-to-edge repair system.

From May 2021 to January 2022, the DragonFly-DMR trial enrolled and treated 120 patients in China. Follow-up data showed that all 120 patientsThe immediate postoperative surgical success rate and device implantation success rate were both 99.2%.The treatment success rate at 12 months post-operation was 87.5% (95% confidence interval: 80.1%, 92.2%). Follow-up results at 12 months post-operation showed significant improvements in the patients' cardiac function and quality of life.This confirmatory clinical trial successfully achieved the pre-specified primary efficacy and safety endpoints with significant treatment outcomes.

During the surgery, 52.5% of subjects in the DragonFly™ device group successfully received one valve clip, while 42.5% received two valve clips. The mean mitral transvalvular pressure gradient (TMPG) immediately post-operation and at 12 months was 2.88±1.34mmHg and 3.19±1.38mmHg, respectively. The performance data of the DragonFly™ device shows comparable results to the latest clinical trial outcomes of leading overseas counterparts, MitraClip and PASCAL.

At the same time, the 12-month postoperative follow-up results showed that the patients' cardiac function and quality of life were significantly improved. The proportion of subjects with NYHA Class I/II heart function increased from 32.4% at baseline to 93.6% at 12 months (P<0.001), and the improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score relative to baseline was as high as 30.64 ± 18.35 points (P<0.001).

DragonFly-DMR trial results show that the DragonFly™ system has good safety, effectiveness, and controllability for treating degenerative mitral regurgitation (DMR), offering a better treatment option for DMR patients at high surgical risk.

1. The surgical approach has transitioned from transapical to transfemoral venous access, significantly reducing invasive procedures and effectively decreasing the incidence of severe postoperative adverse events. This allows more interventional cardiologists to master device operation while providing treatment opportunities for a greater number of patients at high surgical risk.

2. Instruments evolve from complex to user-friendly, enhancing operational friendliness, which facilitates clinical promotion.

3. From single surgery to combined surgery, the use of combined instruments can provide diversified solutions for patients with complex mitral valve diseases, while improving efficacy and treatment durability.

The DragonFly™ product features the following four innovative designs:Enables safer and more effective clamping, adapts to a wider range of patients, offers more intuitive and convenient overall operation, and delivers precise and reliable treatment outcomes.

1. The extensible central blocking net, combined with the ratchet-like self-locking clamp arm for mechanical clipping, ensures stable leaflet capture while reducing leaflet tension and minimizing leaflet damage. It also reduces central residual regurgitation and postoperative transvalvular pressure gradients.

2. Four clip sizes are available to match different anatomical structures of the leaflets, offering more choices for patients with mitral regurgitation caused by various lesions and anatomical variations.

3. Independent grasping can achieve unilateral capture, improving surgical success rates and efficiency in complex cases.

4. A precisely controlled delivery system with a visualized, articulated, and scaled operating system, combined with a unique three-stage adjustable tube design, offers more precise and convenient operation.

DragonFly™ has independent intellectual property rights. As of September 2023, around the product's basic principles, core solutions, and key innovation points, more than 150 domestic and international patents have been applied for, including 95 invention patents and 28 PCT applications, with 30 patents already authorized. Three technical achievements have been published in internationally renowned journals such as "JACC: Asia."

Evaluation by Academician Jian'an Wang from the Second Affiliated Hospital of Zhejiang University School of Medicine:“The DragonFly™ Transcatheter Mitral Valve Clip System is a typical demonstration of the powerful promotion of medical device product R&D and innovation through the combination of medicine and engineering.In August 2019, we successfully completed the world's first animal experiment. In 2020, the team applied DragonFly™ to complete the world's first clinical application in humans. By 2022, we completed the enrollment of the last case in the DMR confirmatory clinical trial. Throughout this journey, we have collectively witnessed the progress and strength of China’s self-developed medical devices. While breaking through technological bottlenecks in China, it also signifies the potential for reverse technology export in the near future. Moving forward, we will continue to align with clinical needs, constantly refine our efforts, and strive to provide better treatment options for mitral regurgitation patients worldwide.

Mr. Zhang Tingchao, General Manager of Valgen Medtech, stated"All that we do is for the patients we serve, to make healthcare more accessible and bring benefits to society. Valgen Medtech has years of technical expertise in the transcatheter mitral valve repair treatment field, along with extensive experience in industrialization, providing more valuable services to patients worldwide."

The diagnosis and treatment technology for structural heart disease is currently at the forefront of global medical innovation. In recent years, China has seen rapid advancements in this field, driven by the rise and continuous progress of local research capabilities and technologies. Today, the approval of the domestically produced DragonFly™ trans-femoral venous mitral valve clip system marks another milestone breakthrough following the 2017 approval of China's first transcatheter aortic valve replacement (TAVR) system. As China's level of diagnosis and treatment for structural heart disease takes the global lead, looking back, the approval of DragonFly™ will stand as a significant highlight in the history of China’s development in this field.

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