An 80-fold revenue gap: how can Chinese cardiac valve makers ever catch up to Edwards Lifesciences?

A striking contrast is unfolding in the cardiac valve market: Chinese domestic cardiac valve manufacturers have firmly dominated the local TAVR (Transcatheter Aortic Valve Replacement) market, collectively holding approximately 80% of the market share. On the other hand, the revenue of China's leading cardiac valve companies lags behind that of international valve giants by over RMB 20 billion.

Examining the details, in the first half of 2025, the global leader in cardiac valves, Edwards Lifesciences (referred to as Edwards), reported revenue of $2.94 billion (approximately RMB 20.79 billion). In contrast, the highest revenue among Chinese companies in the cardiac valve market was generated by Balance Medical, at about RMB 248 million. Compared to this, Edwards' revenue scale is 83 times that of Balance Medical.

Beyond Balance Medical, revenues from the cardiac valve businesses of other Chinese companies such as CardioFlow Medtech, Peijia Medical, Venus Medtech, and Bluesail Medical were RMB 229 million, RMB 162 million, RMB 187 million, and RMB 50 million, respectively. These figures show an even larger gap compared to Edwards' revenue.

Although the cardiac valve business revenues of the aforementioned Chinese companies have maintained high growth rates, the gap remains vast when compared to the revenue scale of Edwards, indicating that Chinese companies still have a long way to go in their pursuit.

This inevitably raises the question: after securing victory in the Chinese market, can Chinese-made cardiac valves achieve a breakthrough in the international market? To reach a revenue scale comparable to Edwards', in which areas must Chinese companies bridge the gaps? The answers to these questions will also shed light on the future growth potential of China's cardiac valve enterprises.

Edwards is the global leader in the cardiac valve market, with all its revenue derived from this sector. Its business is primarily divided into three segments: the TAVR (Transcatheter Aortic Valve Replacement) business, the TMTT (Transcatheter Mitral and Tricuspid Therapies) business, and the Surgical Structural Heart business.

Currently, the TAVR business is Edwards' core operation, generating $2.18 billion in revenue in the first half of the year, accounting for approximately 74% of total revenue. The Surgical Structural Heart business, a traditional segment, reported revenue of $518 million during the same period, representing 17.5% of the total. TMTT is a rapidly growing, high-potential business, with revenue of $249 million in the same period, constituting 8.5% of total revenue.

According to data from Wall Street investment institutions, Edwards holds about a 60% market share in the global TAVR market, maintaining a dominant position.

Facing such a strong competitor, China stands as one of the few markets that has managed to withstand the impact of imported cardiac valve products. The reason Chinese cardiac valve companies have secured an 80% market share in China's TAVR market and successfully countered the advance of imported products lies in their advantages across multiple dimensions, including product offerings, technology, R&D, clinical data, localization, and cost-effectiveness.

First, in terms of products, the product portfolios of Chinese valve companies are on par with Edwards, providing clinicians with a wide range of solutions. Moreover, Chinese-made valves offer differentiated advantages in performance.

As the global leader, Edwards boasts an exceptionally rich product portfolio. However, not all of Edwards' cardiac valve products have entered the Chinese market, which limits its portfolio advantage there. To date, among the valve products approved by the NMPA in China, Edwards has more surgical valves and fewer interventional valves. Approved products include the third-generation TAVR product Sapien 3 valve, pericardial bioprosthesis, dry aortic valves, dry mitral valves, mitral annuloplasty rings (PhysioⅡ, Physio, Cosgrove-Edwards), and tricuspid annuloplasty rings (Physio Tricuspid, MC3, Cosgrove-Edwards), among others.

In China, Edwards' TAVR products do not enjoy the same first-mover advantage they hold globally. Its TAVR products were approved for the Chinese market in 2020, whereas products from companies such as Venus Medtech, JC Medical, and CardioFlow Medtech had already received approval for use between 2017 and 2019. Subsequently, TAVR products from Medtronic, Boston Scientific, Lepu Medical, Peijia Medical, and NewMed also gained approval, intensifying market competition.

In terms of product performance, Chinese-made cardiac valves also possess unique advantages. For example, the first-generation TAVR product launched by JC Medical, a transapical interventional heart valve replacement system, was the first interventional valve capable of treating both severe aortic regurgitation and stenosis. NewMed's Prizvalve Transcatheter Aortic Valve System is the first self-developed balloon-expandable valve approved in China. Venus Medtech has launched four generations of TAVR products, with each iteration featuring upgrades. Its latest fourth-generation product, VenusA-Deluxe, includes further optimizations and enhancements to the delivery system.

Second, similar to Edwards' valves, Chinese-made cardiac valves have also undergone clinical validation with excellent data. A key factor in Edwards' global dominance is its outstanding clinical data: Studies such as the PARTNER 3 trial and the PARTNER series have demonstrated that Edwards' TAVR products, including the SAPIEN 3, showed superiority over SAVR (surgical aortic valve replacement) at one year, along with long-term valve performance, durability, and consistent clinical outcomes.

In this regard, the clinical data for Chinese-made cardiac valves have also been validated through large-scale, long-term studies. In May 2025, Professor Wu Yongjian from Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS) released 10-year follow-up data for Venus Medtech's first-generation TAVR product, VenusA-Valve. The data showed: at the 10-year follow-up, cardiac mortality was less than 20%, confirming its safety; a high proportion of patients had no or trace aortic regurgitation, and over 90% of patients exhibited no, trace, or mild paravalvular regurgitation, confirming its long-term efficacy. Compared to long-term follow-up data for similar self-expanding valves, VenusA-Valve demonstrated lower rates of valve deterioration and bioprosthetic valve dysfunction, indicating superior durability compared to international counterparts.

In October 2025, a team led by Academician Ge Junbo from Zhongshan Hospital, Fudan University published the 8-year long-term follow-up results of CardioFlow Medtech's self-expanding VitaFlow system for patients with aortic stenosis at high surgical risk. The results showed: overall all-cause mortality (39.1%) and the incidence of major adverse cardiac and cerebrovascular events (48.7%) were relatively low, with good maintenance of hemodynamic performance. The rates of structural valve deterioration, bioprosthetic valve dysfunction, and bioprosthetic valve failure were all lower than those reported in previous long-term follow-up studies.

Additionally, Chinese companies such as Peijia Medical and JC Medical have published excellent clinical trials demonstrating the safety, efficacy, and quality of their products.

Finally, Chinese-made cardiac valves benefit from localization and cost advantages. Compared to the pricing of Chinese valves, Edwards' TAVR products are approximately 40% more expensive. This further raises the threshold for Chinese patients to choose Edwards' TAVR products and indirectly strengthens the market competitiveness of Chinese-made TAVR products.

With these multiple differentiated advantages, Chinese-made TAVR products have secured an 80% market share, firmly holding back the advance of imported cardiac valves. However, despite the high market share, TAVR penetration in China remains low, with commercial implant numbers below expectations and the overall market size relatively small, which limits the revenue scale of Chinese cardiac valve companies. It is anticipated that as penetration increases and Chinese valves expand internationally, the revenue of these companies has the potential to achieve breakthrough growth.

While the valve companies that have succeeded in the Chinese market may aspire to extend this success globally, the challenge is significantly greater. Edwards, in the global market, operates with its complete product portfolio and possesses comprehensive advantages in brand recognition, distribution channels, financial resources, and global capabilities. For Chinese companies to continue their winning trajectory, the path forward is far from easy.

Unlike in the Chinese market, where only a limited range of transcatheter valve products are available, Edwards boasts an exceptionally rich global product line. It comprehensively covers transcatheter aortic valves, transcatheter mitral valves, transcatheter tricuspid valves, and surgical valves. This extensive portfolio includes the SAPIEN series of transcatheter aortic valves, the SAPIEN 3 transcatheter pulmonary valve, the SAPIEN M3 transcatheter mitral valve replacement system, the PASCAL Precision transcatheter mitral valve repair system, the EVOQUE transcatheter tricuspid valve replacement system, and a wide array of surgical valve products.

(Product Line Layout of Various Enterprises in the Valve Field)

Meanwhile, Edwards continues to acquire interventional valve companies to supplement its product portfolio and strengthen its market competitiveness. Since August 2024, Edwards has sequentially acquired mitral valve manufacturer Innovalve Bio Medical, the leading company in transcatheter aortic regurgitation therapy JenaValve, the mitral valve product Kalios from French device company Affluent Medical, JC Medical (the overseas subsidiary of Genesis Medtech), and the overseas rights to the transcatheter aortic valve system J-Valve.

In August 2025, the U.S. Federal Trade Commission (FTC) filed for a preliminary injunction in court, seeking to block Edwards' planned $945 million acquisition of JenaValve Technology. However, Edwards stated it will continue to seek regulatory approval for the acquisition of JenaValve, though the process may be prolonged and the outcome uncertain.

Compared to Edwards, the product portfolios of Chinese companies are less comprehensive, with their approved products primarily covering single niche areas. For example, companies such as Venus Medtech, JC Medical, Peijia Medical, CardioFlow Medtech, Balance Medical, and NewMed mainly have TAVR products as their key commercial offerings. Companies like Hanyu Medical, Valgen Medtech, and HuiHe Healthcare have approved products mainly in the field of transcatheter mitral and tricuspid therapies.

Although there is a gap in product lines, Chinese companies each possess distinctive strengths in different market segments. Among them, Balance Medical, as a technological pioneer in China for artificial bioprosthetic valves, holds an advantage in the surgical valve segment, with products such as bovine pericardial valves and annuloplasty rings contributing the majority of its revenue. Venus Medtech, the earliest Chinese company to enter the transcatheter valve intervention field, boasts a richer portfolio of interventional valve products. It has four transcatheter aortic valve products approved by the NMPA, and its transcatheter pulmonary valve product is already used in over 60 countries across Europe, the Middle East, and other regions. Peijia Medical is a platform-based R&D enterprise simultaneously engaged in valve intervention and neurointervention, with multiple commercialized products including the TaurusOne TAVR system, the TaurusElite retrievable TAVR system, and the TaurusMax TAVR system. CardioFlow Medtech, backed by the MicroPort® Group, holds advantages in brand, distribution channels, and resources, with its VitaFlow system and VitaFlow Liberty retrievable system also approved for use.

Furthermore, Chinese companies are strengthening their product line layouts to accelerate their catch-up with Edwards. Balance Medical, which previously derived most of its revenue from surgical valves, launched its interventional valve products in 2024: the transcatheter aortic valve product Renatus system and the transcatheter valve-in-valve system Renato. Beyond this, Balance Medical is also developing a split-type interventional mitral valve, a split-type interventional tricuspid valve, and a split-type interventional ring-in-valve system to enhance its presence in the transcatheter interventional valve field.

In the TMTT (Transcatheter Mitral and Tricuspid Therapies) sector, which Edwards views as another future revenue pillar, Chinese companies such as Venus Medtech, Peijia Medical, and CardioFlow Medtech are also intensifying their efforts. For instance, Peijia Medical has the GeminiOne edge-to-edge repair system, the Sutra TMV coaptation enhancement system, and the HighLife TSMVR system in the transcatheter mitral valve space, and the GeminiOne edge-to-edge repair system in the transcatheter tricuspid valve replacement field, all currently in the R&D or registration application stage. CardioFlow Medtech has VitaFlow SELFValve and AltaValve in the transcatheter mitral valve space, and VitaFlow Triumph along with a replacement system in the transcatheter tricuspid valve field, also in the R&D phase.

Despite accelerating their product line expansions, Chinese companies have undoubtedly lost the first-mover advantage. This will significantly raise the barriers for their entry into the global market: convincing overseas physicians, who already trust products from giants like Edwards, to adopt their products is extremely challenging.

Beyond product portfolios, an even larger gap exists in brand recognition, sales channels, and global capabilities. Compared to the 10–20-year history of Chinese companies, Edwards has approximately 68 years of history in the valve field. Through long-term collaborations with hospitals worldwide, it has built substantial brand equity. Chinese companies, just beginning their international expansion, will need to invest significantly more time, effort, and resources to potentially earn the trust of overseas physicians.

In terms of sales channels and global capabilities, Edwards primarily employs a direct sales model, with products sold in over 100 countries and regions worldwide. The U.S., Europe, and Japan are its core markets. In 2024, approximately 59% of its sales came from the U.S., and 41% from international markets. Of its international sales, 59% came from Europe, 15% from Japan, and the remaining 26% from the rest of the world.

In contrast, Chinese cardiac valve companies are in the phase of building their global capabilities. For example, Venus Medtech's overseas revenue in 2024 was approximately RMB 82.5 million, which remains relatively small. CardioFlow Medtech's TAVR products had entered nearly 100 medical centers across 17 overseas countries or regions by 2024, still in the early stages.

It is worth noting that Edwards' core markets are in regions with strong payment capabilities, high penetration rates, and large market sizes, such as the U.S., Europe, and Japan. In contrast, the international expansion of Chinese valve companies primarily targets regions like the Middle East, Southeast Asia, and Latin America, with limited development and penetration in Europe, the U.S., and Japan.

Additionally, Edwards may engage in patent and commercial strategies to hinder the overseas expansion of Chinese companies, delaying their progress. In June 2021, Edwards filed multiple patent invalidation claims against Cardiovalve, which had been acquired by Venus Medtech for $300 million to advance its internationalization strategy. However, as the patent battle unfolded, Venus Medtech's global strategy was somewhat affected.

By June 2025, this patent dispute finally reached a conclusion: the United States Court of Appeals for the Federal Circuit ruled that Edwards' arguments were unpersuasive and upheld the validity of Cardiovalve's (Venus Medtech's) patent claims. Edwards lost the case, and Cardiovalve (Venus Medtech) prevailed. This victory is crucial for Venus Medtech in accelerating its internationalization and enhancing its brand image. Nevertheless, whether this four-year patent battle ultimately advanced or delayed its global strategy remains difficult to assess.

Overall, Edwards holds a clear advantage in the global market. While Chinese companies possess differentiated strengths in product performance and clinical data, they must address weaknesses in brand recognition, global capabilities, and sales channels to achieve breakthroughs in the international market. By accelerating their development in regions outside Europe, the U.S., and Japan, Chinese companies may leverage cultivated market advantages to capture a certain market share, though this will require long-term accumulation, and significant product uptake will take even more time.