Breaking a 20-Year Western Monopoly: Chinese-Developed DragonFly™ Carves a Path in Europe’s Heart Valve Market

Jun 27, 2026 07:00 CST Updated 07:00

Valgen Medtech

Minimally Invasive Interventional Device Developer

In the field of high-end medical equipment, we have heard such statements too often: core technologies are monopolized by foreign companies, Chinese-made products can only follow and serve as substitutes, and the high-end market will always be the domain of European and American giants.

However, Frankfurt in 2026 completely rewrote this established landscape.

As the “top barometer” of the global field of interventional structural heart disease, the CSI Frankfurt conference brings together the world’s leading cardiac medical technologies and industry experts. On this world-class stage, Valgen Medtech from China has delivered a clinical achievement that has stunned the globe.

Its independently developed DragonFly™ transcatheter valve repair system has demonstrated, through a robust set of European clinical data, that in the global arena of top-tier cardiac interventions, China is no longer a follower but has become a core force reshaping the industry landscape.

More critically, the monopoly barrier that has dominated the global market for 20 years, controlled by the duopoly of Abbott and Edwards Lifesciences, is being thoroughly breached by this Chinese dark horse. The global heart valve device market has officially entered a new era of “tripartite confrontation.”

PART.01

Ten Years in the Making: The Counterattack R&D Journey of Domestic Hardcore Heart Valves

Many marvel at the stunning performance of DragonFly™ in European clinical settings, yet few are aware that this domestically produced cardiac device, which has broken the monopoly held by European and American companies, is the result of a full decade of dedicated efforts and pioneering breakthroughs from scratch.

As early as 2015, the global market for transcatheter mitral valve repair technology had long been monopolized by European and American companies. Imported devices were not only prohibitively expensive but also suffered from a critical drawback: their core designs were tailored exclusively to the cardiac anatomy of Western populations, failing to align with the physiological characteristics of Chinese and Asian patients. Countless elderly and high-risk cardiac patients either could not afford the exorbitant treatment costs or missed the optimal window for intervention due to poor device compatibility.

To address this clinical dilemma and break through overseas technological blockades, Valgen Medtech has officially launched the independent research and development project for the DragonFly™ transcatheter valve repair system, with the aim of creating a mitral valve interventional device that is tailored to the Asian population, independently developed and controllable in China, more cost-effective, and safer to operate.

The R&D barriers for high-end interventional valve devices are extremely high, involving interdisciplinary technologies across materials science, precision mechanics, clinical medicine, and human anatomy. Core patents and foundational designs have long been firmly controlled by European and American giants. To tackle this formidable challenge, Valgen Medtech assembled a top-tier R&D team and joined forces with two leading scientific and clinical powerhouses: the team of Academician Zhang Xingdong from Sichuan University and the team of Academician Wang Jian’an from the Second Affiliated Hospital of Zhejiang University School of Medicine, embarking on a decade-long journey of deep integration among industry, academia, research, and clinical practice.

Throughout the entire R&D process, we remained anchored to clinical pain points and continuously iterated innovations, overcoming a series of core technical challenges such as valve apposition, minimally invasive implantation, precise repositioning, and long-term anti-regurgitation. Our proprietary central occlusion mesh combined with a stepless self-locking structure not only resolves the issue of residual regurgitation associated with traditional devices but also significantly reduces surgical complexity, making it suitable for elderly, frail, and patients with complex conditions.

A Decade of R&D: Solid Steps, Layered Breakthroughs, and Clear Milestones Achieved:

In July 2020, the product successfully completed its first-in-human clinical application, officially embarking on the path of clinical validation;

In 2021, DragonFly™ was successfully selected for the National Special Review Green Channel for Innovative Medical Devices, owing to its disruptive innovative design, thereby receiving official authoritative recognition;

In 2022, the project was successfully selected for the National Key R&D Program of the 14th Five-Year Plan, becoming a national-level key high-end medical innovation project tackling critical challenges;

In November 2023, DragonFly™ officially received marketing approval from China’s National Medical Products Administration (NMPA), becoming the first domestically developed transcatheter mitral valve clip system in China and filling a domestic technological gap;

Subsequently, it continued to secure EU CE certification, obtained dual indications for DMR/FMR approval, and entered 15 countries and regions worldwide, evolving from a domestically developed original medical device into a globally competitive, high-impact product on par with international giants.

Unlike the path of imitation and incremental improvement taken by most domestically produced devices, DragonFly™ represents genuine, fully independent original research and development, with breakthroughs achieved across the entire innovation chain. Through a decade of dedicated effort, starting from addressing critical clinical pain points, it has broken through overseas technological barriers from scratch, ultimately achieving a leading position in China and keeping pace with global competitors. This is the core strength that has enabled it to establish a firm foothold in the stringent European market and deliver a flawless clinical performance.

PART.02

After Two Decades of Entrenched Status Quo, China Finally Breaks the Mold

Anyone familiar with the high-end medical sector knows that the global market for transcatheter edge-to-edge repair (TEER) of the mitral valve has been characterized by an absolute duopoly over the past two decades.

Abbott and Edwards, two major international giants, have firmly monopolized the global market by leveraging their first-mover technological advantages, comprehensive clinical data, and global distribution channels, thereby establishing formidable technological and industry barriers.

For a long time, it was tacitly accepted across the global industry that the top positions in this sector had already been secured by European and American enterprises. No third force capable of rivaling the two giants has ever emerged on the global stage.

But market reshuffling often lies within silent breakthroughs.

As domestic medical innovations accelerate their iterative development, the landscape is subtly reversing. The emergence of DragonFly™ has precisely hit the key turning point in the reshaping of the global market, becoming the first and currently only Chinese medical device with the genuine capability to challenge the duopoly of the two giants.

This is not merely a simple overseas expansion of products, but a historic leap for China’s high-end medical devices, transitioning from “low-end substitution” to “high-end value competition.”

Unlike most domestically produced devices that either focus solely on the Chinese market or are limited to a single certification, DragonFly™ has already achieved comprehensive internationalization. It is the first independently developed transcatheter mitral valve device in China to secure dual certifications from both the China NMPA and the EU CE. Furthermore, it is a rare domestically produced product covering both DMR and FMR indications in the European Union.

To date, this domestically produced high-end medical device has successfully entered 15 countries and regions worldwide, establishing a firm foothold in the international market. It has thoroughly moved away from the passive model of “trading low prices for market share” that once characterized Chinese-made medical devices, now competing head-on with top-tier European and American technologies on equal footing.

PART.03

Robust Clinical Data Conquers the Most Stringent European Market

In the high-end medical sector, there has never been any "bonus for sentiment"; only genuine clinical data serve as the hard currency for establishing a foothold in the international market.

At the CSI Frankfurt 2026 conference, Valgen Medtech’s public release of the one-year European follow-up data for DragonFly–EU DMR sent shockwaves through the industry. The core reason for this acclaim lies in its bold challenge to tackle the most difficult and intractable patient populations in clinical practice, delivering a flawless performance that far exceeded industry expectations.

The patients enrolled in this clinical study had a mean age of 80.5 years, all belonging to the high-risk population for surgical intervention due to advanced age and elevated operative risk. More stringently, all patients presented with severe mitral regurgitation preoperatively, with 66.7% exhibiting grade 4+ (the highest severity level) regurgitation, indicating critical condition and substantial surgical complexity.

Such elderly, critically ill, and high-risk patients have long been a “blind spot” in traditional surgical treatment, characterized by high risks and poor prognosis, with most devices failing to achieve optimal therapeutic outcomes. However, the performance of DragonFly™ has thoroughly shattered the industry’s entrenched perceptions.

Long-lasting efficacy, thoroughly resolving reflux issues

One-year postoperative follow-up data showed a treatment success rate of 86.7%, with 100% of patients experiencing a reduction in cardiac regurgitation to below moderate severity, completely eliminating severe regurgitation. The efficacy remained stable without recurrence, strongly demonstrating the product’s long-term repair capability.

Minimally Invasive and Highly Efficient, Significantly Reducing Trauma in Elderly Patients

Both the immediate procedural success rate and the device implantation success rate reached 97.4%, demonstrating exceptional surgical precision. Notably, over 60% of patients required only a single mitral valve clip for successful repair, significantly shortening operative time and minimizing tissue trauma, thereby optimally accommodating the physiological tolerance of elderly and frail patients.

Reversing Heart Failure to Tangibly Improve Patients' Quality of Life

By 30 days postoperatively, all patients’ cardiac function had recovered to NYHA Class I/II, and this favorable status was stably maintained through one year post-surgery. Anatomical reverse remodeling of the cardiac structure was achieved, effectively delaying and halting the progression of heart failure, thereby truly realizing the dual goals of “treating the disease and preserving quality of life.”

Beyond standardized clinical studies, real-world application cases from Turkey further demonstrate the superior stability of DragonFly™.

In ultra-high-risk, complex cases such as uremic cardiomyopathy and chronic renal failure, this domestically produced device continues to demonstrate stable performance and superior efficacy. Its reliable performance across diverse geographic regions and complex pathological scenarios represents the core strengths most recognized by top global clinical experts—predictability, reproducibility, and ample safety.

PART.04

Seize the Golden Window, Secure a Seat in the Global Third Pole

The global competition in high-end medical devices has never been a case of “slow and steady wins the race”; rather, it is a sprint with an extremely narrow window of opportunity, where victory or defeat is determined in the blink of an eye.

There is a widely recognized golden rule in the industry: The 24-month period following a new product’s attainment of international regulatory approval constitutes the decisive window for securing global channel positioning, capturing expert resources, and establishing academic thought leadership.

High-quality overseas distributor resources and collaborations with core clinical experts are inherently limited. Missing this two-year golden window will cause subsequent market access costs, technical barriers, and brand barriers to skyrocket exponentially, making any future breakthrough attempts as difficult as scaling the heavens.

Every strategic move of DragonFly™ has precisely capitalized on key market opportunities.

The significant release of these European clinical data is far more than a mere academic presentation; it represents a pivotal battle for Valgen Medtech during this period of global landscape reshaping. This milestone not only solidifies the brand’s academic standing in the high-end European medical market but also establishes the most core evidentiary foundation for the product’s expansion into additional global regions and broader indications.

Valgen Medtech has already secured the key to entering the world’s top-tier markets, yet its efforts to break through in brand building have never ceased.

Over the next two years, the brand will continue to supplement its portfolio with data from large-sample randomized controlled trials and expand global real-world follow-up cases, thereby continuously refining a comprehensive, multi-dimensional evidence chain. Given the current momentum, DragonFly™ possesses the strength and confidence to emerge as the third major player in the global TEER market, following Abbott and Edwards, thus officially ushering in a new industry landscape characterized by a tripartite balance of power.

PART.05

Not Just One Product Breaks Through: China’s Medical Industry Stages a Era-Defining Comeback

Many people only see the successful overseas expansion of a single domestically produced medical device, yet they overlook the broader reality: this achievement represents a full-chain breakthrough for China’s high-end medical industry.

In the past, our high-end medical innovations were long trapped in a predicament of “following and imitating,” with core technologies, clinical standards, and global channels all controlled by foreign entities.

Today, domestic innovations represented by DragonFly™ have achieved independent breakthroughs across the entire value chain, from R&D and global regulatory registration to clinical validation and overseas channel deployment.

It demonstrates to the world that China’s high-end medical devices are no longer confined to low-end substitution; equipped with original technologies, robust clinical evidence, and global competitiveness, they are poised to take center stage in the world’s top-tier healthcare arena and compete head-to-head with international giants.

The wave of reshaping the global valve market has already begun, and the era-defining opportunity for Chinese medical innovation has arrived.

From catching up to keeping pace, and then to taking the lead in select areas, DragonFly™’s European performance is not merely a corporate breakthrough, but the strongest testament to the rise of China’s high-end medical industry.

Looking ahead, we anticipate that more domestic medical innovation forces will break through barriers and go global, showcasing the hard power of China’s intelligent manufacturing to the world!