Breaking Through Shockwave's Dominance: How Chinese IVL Companies Accelerate Global Expansion Amid Patent Barriers

Intravascular Lithotripsy (IVL) technology has become a hotly contested sector in the global medical device industry, thanks to its breakthrough value in treating intravascular calcified lesions. Against this backdrop, Chinese IVL companies are rising rapidly. Over the past two years, the approval process for domestically produced IVL products has accelerated significantly; to date, nine such products have successfully launched on the market, and multiple companies have initiated or are poised to embark on their global expansion journeys.

As the pioneer of IVL technology, Shockwave Medical has leveraged its first-mover advantage to establish a robust patent protection network and a solid market position, setting high barriers for latecomers. In the face of its patent blockade and market monopoly, how can Chinese manufacturers achieve technological breakthroughs, pursue differentiated competition, and implement global expansion strategies?

VCBeat interviewed leading industry players, including Huihe Medical, Puchuang Medical, Jiamuyao, and Blue Sail Medical, to explore the breakthrough pathways for domestic intravascular lithotripsy (IVL) enterprises from the perspectives of patent-avoidance innovation, product performance iteration, and the implementation of overseas expansion strategies.

Shockwave Medical was founded in California, USA, in 2009 and listed on the NASDAQ in April 2019, becoming the world’s first shockwave balloon company.

As the pioneer of IVL technology, Shockwave has innovatively applied extracorporeal shock wave lithotripsy (ESWL), a treatment for kidney stones, to endovascular procedures.IVL technology delivers pulsed acoustic pressure waves to calcified lesions via a balloon catheter, “loosening” the calcified plaque to restore vascular elasticity and blood flow, thereby remodeling the diseased vessel while avoiding damage to the vascular intima.

Shockwave’s products received the U.S. FDA Breakthrough Device designation in 2019 and have been approved for clinical use in both the European Union and the United States for the treatment of calcified lesions in coronary and peripheral arteries, achieving significant commercial success since their market launch.

Meanwhile, Shockwave is also the earliest commercially available intravascular lithotripsy (IVL) balloon product in China. In May 2022, Shockwave’s intravascular lithotripsy series received approval from the National Medical Products Administration (NMPA) for market launch. GenScript Biotech secured exclusive distribution rights for Shockwave in China and initiated localized production of the product.

On May 31, 2024, Johnson & Johnson completed its acquisition of Shockwave Medical for a total consideration of approximately $13.1 billion, providing robust empowerment to Shockwave across multiple dimensions, including technology R&D, product iteration, global market expansion, manufacturing capacity, clinical evidence generation, and academic influence.

Shockwave Medical’s technological breakthroughs and commercial success have not only reshaped the clinical pathway for treating vascular calcification but also established a robust industry moat through global patent deployment and market strategies, thereby creating high barriers to entry in the intravascular lithotripsy (IVL) sector.

In terms of patent portfolio strategy, Shockwave initiated its patent applications during 2007–2008. To date, the company holds more than 200 patents worldwide, with the most comprehensive and robust patent protection established in the U.S. market. By comparison, the scope and number of patents in markets such as Europe and Japan are somewhat less extensive than those in the United States. In China and other emerging markets, its patent layout is relatively weak, with the earliest granted patents dating back to 2014–2015.

Shockwave’s core innovation in the electrohydraulic shockwave technology pathway lies in its electrode structure design, specifically manifested through systematic innovations in the layered configuration of inner and outer electrodes, perforation design, and wire connection methods. Furthermore, its peripheral patent portfolio covers several core inventive concepts, preventing subsequent competitors from circumventing patents by altering electrode layout and morphology. This creates a substantive technological blockade for companies adopting the same technology pathway, namelyRelevant companies must avoid infringing on its core electrode structure design, necessitating the development of new structural designs and validation from scratch, which poses significant challenges.This is also one of the biggest obstacles faced by latecomers in the development of IVL products.

At the market level, Shockwave Medical, as a U.S.-based company, has seen robust growth in its domestic market, with 79% of its total market share in 2023 coming from the United States.Its monopoly in the U.S. and European markets is difficult to shake.. According to Shockwave, its products have been widely adopted internationally. From commercialization through October 2020, they had successfully treated more than 25,000 patients with coronary artery disease and more than 27,000 patients with peripheral artery disease.

Against this backdrop, how should domestic IVL companies break through?

First,To develop IVL products without infringing on patents, it is essential to circumvent Shockwave's patent barriers regarding IVL electrode structural design.. Currently, domestic enterprises have explored solutions through various pathways, with innovative designs aimed not merely at patent circumvention but at optimizing product performance to enhance clinical safety and efficacy.

Dr. Peng Huiqun, CEO of Puchuang Medical, stated that from the outset of its R&D efforts in 2018, the company established “circumventing the patent barriers surrounding Shockwave’s electrode structural design” as a core objective. Unlike Shockwave’s nested inner-outer structure with aperture designs, Puchuang Medical’s Sonico-CX® system features electrodes arranged in a single-layer longitudinal configuration with an annular end-face design, enabling uniform 360° circumferential delivery of shockwaves.

The company’s IVL product adopts a “floating electrode” design principle. This technical approach successfully circumvents the restrictions of Shockwave Medical’s early foundational patents while achieving miniaturization of the catheter size and optimization of the assembly process. The company has established a global patent protection network covering China, the United States, and other major overseas markets. It has filed a series of patent applications in multiple countries, thereby forming a comprehensive intellectual property protection system.

Jiamuyao Medical has effectively circumvented Shockwave’s core patents through innovative designs of its electrode structure and device-side components. Founder Li Lifu stated that while current domestically produced IVL products share similar shockwave generation principles with those of Shockwave, Jiamuyao has implemented numerous differentiated innovations in its product electrode structure that distinguish it from Shockwave, and has established a comprehensive patent portfolio.

Lifetech Scientific’s cardiovascular and cerebrovascular division subsidiary, Lifetech Boyuan, has independently developed an exclusive patented electrode technology that enables its IVL system, SoniCracker, to achieve a larger discharge angle and discharge gap, along with a wider acoustic pressure range and more uniform acoustic pressure distribution. This patented electrode technology allows for higher acoustic pressure intensity at lower voltages while providing broader energy distribution. Within the effective working space, the acoustic energy available for treating calcified lesions is higher and more uniformly distributed, demonstrating outstanding performance compared to similar products. Under OCT observation, SoniCracker can easily fracture deep, large-angle calcific rings, significantly improving vascular compliance and stent expansion. Currently, Lifetech Scientific has established patent layouts for multiple technologies in numerous countries.

In IVL technology,Balloon PassabilityIt is the core determinant of treatment efficacy in calcified lesions. When confronting hard calcified plaques or tortuous vascular pathways, the balloon must efficiently traverse the lesion; its crossability directly impacts procedural duration, the risk of vascular injury, and the overall success rate of the intervention.

From a technical perspective, parameters such as the compliance of balloon materials, taper angle design, wall thickness, and folding memory are closely related to balloon crossability. Currently, domestic companies are focusing on these aspects to improve the crossability of balloon catheters, thereby creating differentiated advantages in clinical applications.

In response to clinical feedback regarding the insufficient trackability of imported products, the Jiapuyao team has conducted systematic mechanistic studies. By utilizing differentiated materials and adjusting the balloon taper angle, they have enhanced the trackability of their balloon catheters, earning high recognition from numerous clinical experts. Puchuang Medical’s IVL system adopts a wireless electrode design, which effectively reduces catheter size while improving flexibility, ensuring easier navigation through tortuous vessels. Its second-generation product features an optimized design, reducing the balloon catheter size by more than 20% compared to existing products.

Huihe Medical’s C-Wave® system, through further optimization of its hydrophilic coating process, enables easy navigation across stenotic and tortuous lesions. Its ultra-thin outer catheter combined with an extremely fine tip diameter, integrated with precision balloon crimping technology, significantly enhances deliverability in complex tortuous anatomy. The system demonstrates superior performance in managing complex calcified lesions—such as long-segment diffuse, eccentric, and angulated tortuous lesions—thereby reducing the need for predilation.

“The biggest challenge facing IVL at present lies in the high requirements for the deliverability of the balloon catheter. Since calcified lesions are commonly associated with severe stenosis and complex vascular anatomy, crossing the lesion with the balloon is often difficult,” stated Blue Sail Medical. The company will continue to enhance the ability of its IVL catheters to cross lesions, providing comprehensive technical support for the clinical promotion and application of IVL technology, particularly in primary healthcare settings.

Furthermore,Energy Release Stability and Number of Energy ReleasesAs a core metric of the IVL system, it is crucial for the treatment of intravascular calcification. Stable energy delivery ensures that shockwaves precisely target calcified plaques, achieving uniform fragmentation and preventing excessive vascular wall injury or incomplete calcification modification due to energy fluctuations. Meanwhile, an appropriate number of energy deliveries not only guarantees adequate treatment of calcified lesions and reduces risks associated with repeated operations, but also alleviates “pulse anxiety” during clinical procedures, thereby enhancing treatment efficiency.

Shockwave’s IVL system electrodes adopt a nested double-layer structural design. Due to the need to control the catheter’s outer diameter, the thickness of the electrode rings is strictly limited. During discharge therapy, the electrodes undergo wear due to electrical erosion, and the thinner electrode structure accelerates this degradation process.

Puchuang Medical’s IVL electrodes feature a single-layer, ring-shaped end face, effectively addressing this critical challenge. According to Dr. Peng Huiqun, the company’s Sonico-CX® Coronary Intravascular Lithotripsy System achieved a significant technological breakthrough in the number of energy deliveries during its R&D phase. Based on published literature, this product is the world’s first IVL system capable of delivering up to 180 pulses with a single catheter. Subsequent large-scale clinical validation and commercial application assessments revealed that optimizing the pulse count to 120 meets the clinical needs of over 90% of single target lesions, as well as the treatment requirements for multi-vessel and long lesions. This precise design ensures clinical efficacy while enhancing the product’s cost-effectiveness and operational efficiency.

Jiamuyao Medical achieves stable and efficient energy output by modifying the system’s power supply method. According to founder Li Lifu, the company’s intravascular lithotripsy (IVL) product abandons the battery-powered approach in favor of direct plug-in power supply. This stabilizes the input energy to the device, enabling more precise and stable energy release from the catheter-tip electrodes. As a result, the amplitude of energy output fluctuations is reduced while energy utilization efficiency is improved. This allows all patients to complete treatment with a single catheter; even for 360-degree circumferential calcification as visualized on intravascular optical coherence tomography (OCT) imaging, only one catheter is required for management.

Addressing the characteristics of Chinese patients, who often present with longer segments of intravascular calcification and relatively severe calcification, Huihe Medical’s C-Wave® adopts an innovative “spiral electrode arrangement” to achieve 360° full-fan discharge, demonstrating excellent performance in the uniformity of shockwave energy release.

Furthermore, Huihe Medical’s next-generation C-Wave® coronary intravascular lithotripsy catheter has been upgraded, with an 87.5% increase in the number of pulses. Each catheter can deliver up to 150 pulses, totaling 600 shockwaves (150 pulses × 4 discharge sites), significantly extending the treatment window and further improving the efficiency of vascular calcification pretreatment. Meanwhile, the C-Wave® adopts a counter-rotating dual-electrode design with a total of four discharge sites. All sites can be synchronously activated with a single-button trigger, instantly generating four shockwaves, thereby achieving more efficient fragmentation of calcified plaques at the same number of pulses.

In addition to the two core metrics of balloon crossability and energy delivery stability, domestic manufacturers have established differentiated advantages across multiple dimensions, including balloon design, regional variations in operators’ procedural habits, expansion of indications, product specifications, and cost-effectiveness.

The SoniCracker system under Blue Sail Medical adoptsDouble-Layer Balloon Technology, while achieving superior compliance, the balloon can withstand higher inflation pressures. Its therapeutic pressure, nominal dilation pressure, and rated burst pressure are all improved compared to similar products. Specifically, the increase in therapeutic pressure enables better wall apposition of the balloon, thereby reducing energy loss during transmission; meanwhile, the higher rated burst pressure provides excellent post-dilation capability following acoustic pressure therapy, ensuring more adequate vessel preparation.

In addition, there are 18 SoniCracker shockwave balloon catheters in total.Specifications and Models, with a wide range of applications, particularly adding a 15mm balloon length specification and a smaller 2.00mm balloon size, fully meeting the needs for pretreatment of complex lesions in different scenarios.

InClinical Value and Evidence System ConstructionThe pre-market clinical trial of SoniCracker, a product under Blue Sail Medical, known as the LEAD-FIM study, was led by Academician Han’s team from the General Hospital of the Northern Theater Command. This study adopted a prospective, multicenter, single-arm target value design, enrolling a total of 184 patients with severely calcified coronary lesions. The target lesions were required to have a vessel diameter of 2.25–4.0 mm and a stenosis degree of ≥70%, or ≥50% with evidence of ischemia. The primary endpoint was residual stenosis ≤30% after stent implantation, with no major adverse cardiac events (MACE), including cardiac death, myocardial infarction, or target vessel revascularization, occurring during hospitalization (up to 7 days post-procedure). The study results showed a procedural success rate as high as 96.7%, demonstrating an optimizing trend compared to the 92.4% reported in Shockwave’s Disrupt CAD series studies.

For overseas clinicians and domestic operators inDifferences in Surgical PracticesPuchuang Medical has implemented targeted optimizations to the energy delivery trigger mechanism of its IVL system. Current mainstream products, such as those from Shockwave Medical, adopt a single handpiece button design. However, this configuration presents significant limitations in single-operator scenarios: when the physician needs to simultaneously manipulate the catheter and activate the device, one-handed operation becomes difficult, often necessitating assistance from a colleague. To address the diverse clinical needs across different markets, Puchuang Medical has innovatively developed a dual-trigger mode featuring both foot pedal and handpiece button activation. The foot pedal design is specifically optimized for independent operator scenarios, freeing both hands to enable single-person operation. Meanwhile, the retention of the handpiece button trigger ensures compatibility with traditional surgical workflows, offering physicians flexible operational choices.

Jiamuyao Medical’s IVL system also features a foot pedal design. Recognizing that physicians utilize multiple medical devices during the management of complex vascular lesions, often within limited operative space, Jiamuyao’s IVL system enables pulse delivery via foot pedal activation, thereby preventing device displacement caused by accidental contact. Furthermore, the console of Jiamuyao’s IVL system adopts a vertical design, resulting in a smaller footprint and facilitating easier placement in the operating room.

For highly stenotic or chronic total occlusion (CTO) lesions, existing shockwave balloons are difficult to achieve therapeutic efficacy due to the inability of the catheter to cross the lesion. Such lesions account for 5%-8% of patients undergoing percutaneous coronary intervention (PCI), and currently, the only clinical option available is rotational atherectomy. However, rotational atherectomy has issues such as a long learning curve and numerous procedural complications, which prevent most hospitals from offering this procedure. Operators also remain cautious about its application and even try to avoid choosing this technique whenever possible.

To address this pain point, Puchuang Medical is leveraging shockwave technology to developCoronary IVL System for the Treatment of Highly Stenotic or Chronic Total Occlusion (CTO) Lesions. Meanwhile, Puchuang Medical is also developing an IVL system for the treatment of valvular heart disease.

Furthermore, in the field of intravascular lithotripsy (IVL), Blue Sail Medical has expanded its applications beyond the currently well-established areas of coronary and peripheral interventions to includeInnovative strategic layout in therapeutic areas such as neurovascular and structural heart disease。

In its early stages, Shockwave Medical adopted a high-price strategy for large-scale equipment in overseas markets. Leveraging its monopoly as the sole market participant at the time, it secured pricing power for its Intravascular Lithotripsy (IVL) products. Furthermore, the multi-tiered coverage of the U.S. healthcare system and the flexible mechanisms of commercial insurance resulted in a lower priority being assigned to “cost-effectiveness” in medical decision-making. However,Excluding the U.S. market, most overseas markets such as Europe generally find Shockwave’s pricing strategy unaffordable, resulting in significant demand for cost-effective intravascular lithotripsy (IVL) products. This creates certain market opportunities for Chinese companies.

Taking China’s online listing prices as an example, Shockwave Medical’s products are priced at RMB 29,800, whereas comparable domestically produced alternatives—such as Shenzhen Saihe’s at RMB 19,800 and Beijing Lepu’s at RMB 17,800—offer a price advantage. These Chinese-made products are well-positioned to capture price-sensitive overseas markets by leveraging their cost-effectiveness.

In the Chinese market, constrained by the DRG payment mechanism, the per-case cost for coronary artery surgery in some regions is capped at RMB 30,000–35,000. Even with the hospital procurement price of the Shockwave catheter reduced to RMB 24,000, it still accounts for a significant portion of the DRG reimbursement, thereby posing certain challenges to its clinical adoption nationwide. “Against this backdrop,Cost-effectiveness has become a major competitive advantage for domestically produced products in breaking through Shockwave’s market barriers. However, it is crucial to emphasize that product efficacy must not be overlooked in this process.“Li Lifu, founder of Jiamuyao, stated.

Currently, Shockwave’s market focus in China is on large tertiary Grade A hospitals. AndDomestic IVL products, leveraging their cost-effectiveness advantage, are poised to unlock greater potential in the primary healthcare market.Shen Jianwen, CFO of Huihe Medical, stated that although IVL products present significant design challenges, they have a low barrier to clinical adoption; physicians proficient in standard balloon catheter procedures can readily utilize them, laying the foundation for broader technological dissemination. Despite being an emerging technology that will require time to achieve comprehensive penetration into primary care hospitals, its potential for wider adoption is promising.

Driven by significant clinical value, high treatment efficiency, and a low technical barrier, intravascular lithotripsy (IVL) technology will soon penetrate primary care hospitals, making this segment a critical battleground for domestic manufacturers. However, compared with physicians at large tertiary Grade A hospitals, those in primary care settings generally lack experience in managing complex lesions and surgical complications, which will severely test the market education capabilities of domestic manufacturers.

In mature markets such as the United States and Europe, Shockwave Medical established an early presence and has built a deep collaborative network with leading key opinion leaders (KOLs) in these regions. However,Prior to its acquisition by Johnson & Johnson, Shockwave was a startup that primarily focused its market expansion efforts on the United States and core European markets. With insufficient patent and market positioning in emerging markets, it faced relatively less competitive pressure, thereby creating favorable opportunities for Chinese IVL companies to enter these emerging markets.

Li Lifu, founder of Jiamuyao, stated that the existing market size in Southeast Asia is substantial, with significant growth potential in the future. Based on this, the company will use the Southeast Asian market as a strategic foothold to gradually expand into regional markets such as the Middle East, North Africa, and South America, before tackling the US and European markets. “Given the influence of ethnic genetic differences, dietary habits, and lifestyle factors on disease manifestations, ethnic characteristic analysis is an indispensable component of clinical protocol design during cross-regional expansion,” said Li Lifu. The company will initiate overseas multi-center clinical trials as part of its global expansion strategy and carry out targeted product optimizations based on physiological characteristics and differences in disease spectra among patients in different regions.

Puchuang Medical has chosen to enter the IVL market segment not yet occupied by Shockwave Medical, with a strategic focus on countries along the “Belt and Road” initiative. According to Dr. Peng Huiqun, as an early IVL technology provider in Indonesia, Thailand, the Philippines, and most South American countries, Puchuang Medical has become the first company to commercialize this technology in these markets.

Furthermore, Puchuang Medical is preparing to enter the mature markets of Europe and the United States and has already initiated the process for European market access. Dr. Peng Huiqun introduced,European physicians have a clear demand for technological iteration, creating an entry opportunity for domestic IVL products.Puchuang Medical’s IVL product has established technical appeal through innovative designs such as its circumferential 360-degree energy distribution, and post-market clinical studies will subsequently provide evidence-based support for these technological advantages.

In the initial phase of entering emerging markets, to promote the adoption of IVL as an emerging technology, Puchuang Medical dispatched technical teams rather than marketing personnel to handle frontline engagement. Marketing team involvement was planned only after regional market awareness of the technology increased and clinical applications gradually matured. Dr. Peng Huiqun stated that this strategy enabled the company to provide targeted professional technical support to emerging markets, earning recognition from many overseas experts.

Blue Sail Medical has proactively completed its overseas layout across the entire value chain of R&D, production, and sales, thanks to its forward-looking foresight. The company’s Cardiovascular and Cerebrovascular Division boasts a well-structured team, mature channel distribution, and stable customer partnerships in overseas markets, providing a fertile ground for the rapid global expansion of its IVL products.

The Company will prioritize regions where local registration qualifications can be obtained, leveraging its accumulated overseas distribution channels to further expand market presence. Blue Sail Medical stated that the Company is also preparing international versions of its products to facilitate market access in more countries. In the future, SoniCracker plans to conduct phased post-market clinical studies in multiple overseas regions, focusing on ethnic differences to validate the efficacy of Intravascular Lithotripsy (IVL) in treating severely calcified lesions across diverse racial populations. Meanwhile, the Company intends to launch larger-scale post-market clinical studies to lead the operational philosophy and standardize procedural guidelines for IVL in the global treatment of calcified lesions.

Regarding the future development direction of IVL technology, Shen Jianwen, CFO of Huihe Medical, stated that the company will focus on two major areas: first, innovating shockwave generation methods, such as using laser technology to circumvent existing patent restrictions and establish patent differentiation from competing products; second, advancing functional integration by incorporating drug-coating and scoring capabilities into shockwave balloons, thereby enabling a single-balloon approach to replace multi-balloon procedures and optimizing combined application scenarios.

Li Lifu, founder of Jiamuyao Medical, stated that in addition to the electrohydraulic shockwave technology pathway, companies in overseas markets have already begun exploring the use of lasers or carbon dioxide to generate shockwaves. For Chinese IVL companies to truly advance to the “me-better” stage, they need to explore innovative energy-induction methods or adopt mature technological pathways that can be adapted for intravascular calcification treatment. We look forward to seeing how domestic companies will perform as they open up new frontiers in second-generation IVL technology.