Cardiovalve Ltd. Files Patent Infringement Lawsuit Against Edwards Lifesciences Over PASCAL Precision System in U.S. District Court

# Core of the Lawsuit: Battle-Tested Hardcore Patents and Rapidly Growing Products Involved in Litigation

Patents That Have Stood the Test

The case involvesUS’385 Patent Titled "Cardiac Valve Implant" Covers an Innovative Technology for Transcatheter Artificial Heart Valve Clipping and Support Structures, Applicable to Minimally Invasive Treatments for Mitral and Tricuspid Valves. The patent claims a minimally invasive and precise "edge-to-edge" leaflet repair method achieved through a unique dual-clip independent control system. Notably, the "value" of this patent has withstood rigorous tests: A review of the litigation involving US’385 reveals that as early as 2021, Edwards initiated an Inter Partes Review (IPR) procedure at the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office, attempting to invalidate it. However, in December 2022, PTAB issued a final written decision upholding the validity of the amended claims of the patent. Edwards subsequently appealed to the United States Court of Appeals for the Federal Circuit (CAFC), but the appeal was dismissed in June 2025. This has made the legal foundation of US’385 extremely solid.

In addition,The patent family to which US’385 belongs traces its earliest priority claim back to 2011. This family includes dozens of granted U.S. patents, reflecting Cardiovalve's forward-looking and continuous innovation in this technology field as well as its sophisticated patent strategy. As a wholly-owned subsidiary of Venus Medtech, Cardiovalve completes the product portfolio puzzle for mitral and tricuspid valves under Venus Medtech’s "Quadra-Valve Integration" strategy and plays a core role in driving the company’s second growth curve. With Venus Medtech announcing in 2025 the completion of patient enrollment for Cardiovalve’s pivotal CE-mark registration clinical trial involving 150 patients and the submission of the CE-mark registration application, this move to defend and assert intellectual property rights has significantly increased Cardiovalve’s tangible value, transitioning it from a "potential project" to a "revenue-supporting project."

Rapidly Growing Products Involved in Litigation

Involved in litigationEdwards PASCAL, part of the TMTT (Transcatheter Mitral and Tricuspid Therapies) division, has maintained over 50% year-over-year growth in global sales for the past three years. Global sales are projected to reach $550 million by 2025, with PASCAL being the primary contributor, already achieving annual global sales in the hundreds of millions of dollars. It is expected to become a "blockbuster product" with annual sales reaching $1 billion. PASCAL is not only Edwards’ current revenue...FastOne of the engines of growth, and more importantly, one of the strategic cornerstones for maintaining its leadership position in the field of structural heart disease in the future., the market position is evident, which is also why Edwards initiated the IPR procedure for the involved US’385 patent several years ago.ImportantReason.

# Strategic Intent: Intellectual Property Utilization from Defense to Offense

Cardiovalve Shifts from a Defensive Stance Against Edwards' Patent Invalidity Challenge to an Aggressive Posture by Filing a Patent Infringement Lawsuit. This "From Defense to Offense" Transition Highlights Venus Medtech and Cardiovalve's Proactivity and Maturity in Intellectual Property Strategy.

Dare to"Unsheathing the Sword" to Face Global Leading Enterprises: A Display of Confidence in Technological Innovation in the Transcatheter Valve Field and Determination to Protect Achievements Using International Rules. The process of U.S. patent infringement litigation is complex, with approximately 95% of patent lawsuits ultimately ending in "settlement." The litigation itself often serves as a critical component in commercial博弈. Clarifying patent boundaries and value through legal procedures lays a solid foundation for potential commercial negotiations (such as licensing or collaboration).

This lawsuit is an integral part of Venus Medtech's global intellectual property strategy. A comprehensive patent layout is not only the cornerstone of technological innovation."Protective umbrellas" and "moats" are also "passports" and "bargaining chips" for companies to "go global" and participate in international market competition, cross-border mergers and acquisitions, or technical cooperation.

This lawsuit inevitably reminds people of Abbott andEdwards' Patent War Over PASCAL: An Industry History. In 2009, Abbott acquired Evalve, gaining access to its revolutionary product MitraClip and a core portfolio of related patents, leveraging transcatheter edge-to-edge repair technology.（TEER）The basic patent, onIn 2019, a patent infringement lawsuit was filed against Edwards' competitive product, the PASCAL system, developed by the later entrant, aiming to prevent or delay its market entry. In July 2020, the two parties reached a global settlement agreement, with Edwards making a one-time payment of $368 million to Abbott, plus an estimated $100 million in patent royalties up to 2024. By paying patent royalties to Abbott, Edwards secured the right to sell the PASCAL system in the global market. This indicates that Abbott's patent barriers have been validated and monetized, while Edwards paid an "entry fee" to successfully bring the PASCAL system to market, forming the current TEER (Transcatheter Edge-to-Edge Repair) market landscape dominated by the two giants, MitraClip and PASCAL.

This lawsuit seems to be a replay of history. If Venus Medtech ultimately wins and the court rules in its favorEdwards constitutes willful infringement. In view of the fact that PASCAL is a core product worth hundreds of millions of dollars and experiencing rapid growth, Edwards may face huge compensation. A more likely outcome is that the two parties will reach a global settlement and patent licensing agreement. The deepest impact is the potential market access and reshaping of the competitive landscape, which will have a profound impact on the valuation and strategy of Venus Medtech. By this means, Venus Medtech can establish a strong patent barrier and right to speak in the TEER field, transforming from a "challenger" of technology to one of the "participants" or even "formulators" of the rules, most directly bringingExtremely considerableCash FlowSupplement，ShowcaseThe enormous commercial value of its intellectual property.

# Industry Insights: The Innovative Power of China"Going Global" New Paradigm

Venus Medtech PassesThe lawsuit initiated by Cardiovalve provides a deeper strategic insight beyond mere product sales for Chinese medical device companies "going global":

• Innovation is Fundamental：PatentThe confidence in litigation stems from truly original and highly valuable core technologies. Continuous investment in research and development, and the establishment of a solid patent barrier, are the foundation of a company's internationalization.

• Intellectual Property is a Weapon: In the globalized market, intellectual property is a comprehensive weapon that spans multiple dimensions including legal, technological, commercial, and market aspects. Enterprises need to establish a forward-looking global intellectual property layout and management system, and learn to proactively use tools such as patent litigation to safeguard and enhance their positions.

• Strategy is the blueprint: Intellectual property work should be deeply integrated into the company's business strategy, R&D planning, and market expansion. From patent mining, application to operation, maintenance, and even litigation response and initiation, a global perspective and strategic determination are required.

Cardiovalve's Patent Infringement Lawsuit Against Edwards: A Clear Signal of China’s Medical Device Enterprises Competing Globally with Intellectual Property

We look forward to the subsequent developments in this case and will continue to pay attention to how Venus Medtech, with its excellent innovation capabilities and strategic intellectual property management, wins greater respect and success on the international stage, providing a path for the globalization of China's high-end medical device industry.ImportantExample.

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