Venus Medtech Wins Major Patent Victory for Cardiovalve Against Edwards Lifesciences
In a landmark decision, Venus Medtech (Hangzhou) Inc. has emerged victorious in a patent dispute involving its wholly-owned subsidiary, Cardiovalve Ltd. against Edwards Lifesciences Corporation. The U.S. Court of Appeals for the Federal Circuit (CAFC) officially upheld the previous ruling of the Patent Trial and Appeal Board (PTAB), which confirmed the validity of Cardiovalve’s patent portfolio. This ruling not only emphasizes the strength of Cardiovalve’s intellectual property but also enhances the competitive landscape for Venus Medtech in the field of structural heart diseases, particularly around their next-generation integrated platform known as Quad-Valve.
The case revolved around U.S. Patent No. 10,702,385 (the ‘385 patent), which focuses on an innovative transcatheter valve-clamping and support structure designed for minimally invasive mitral and tricuspid valve therapies. Edwards initially challenged the validity of this patent on June 2, 2021, by requesting an inter partes review of the claims. However, on December 6, 2022, the PTAB ruled in favor of Cardiovalve, dismissing Edwards' claims of non-patentability due to insufficient evidence. The CAFC confirmed this ruling on June 9, 2025, reiterating the legitimacy of Cardiovalve’s patent assertions.
The patent dispute highlights the critical advancements within Cardiovalve's technology, aiming to address significant issues in heart valve interventions. Cardiovalve's devices are engineered using groundbreaking technologies, including a self-expanding Nitinol stent designed to minimize paravalvular leakage and a flat stent structure that helps reduce the risk of left ventricular outflow tract (LVOT) obstruction. Moreover, its transfemoral-transseptal access offers a less invasive alternative to traditional approaches, improving patient recovery experiences.
In addition, Cardiovalve's innovative implantation process, which consists of three crucial steps—Positioning, Anchoring, and Releasing—is designed for improved reproducibility and precision.
The recent judgment not only fortifies Cardiovalve’s patent standing but also positions Venus Medtech as a pivotal player in the global cardiology market. Lim Hou-Sen, CEO of Venus Medtech, emphasized the significance of this ruling, stating, "This groundbreaking victory reaffirms the original innovations of Cardiovalve and demonstrates the integrity of global intellectual property systems. We remain committed to advancing structural heart therapies through clinically driven innovations."
Similarly, Amir Gross, CEO of Cardiovalve, expressed optimism regarding future developments, stating, "Our philosophy, ‘Innovation Never Stops’, has overcome technical barriers in mitral and tricuspid interventions. This four-year legal affirmation accelerates our global clinical strategy, which aims to provide superior solutions for the more than 40 million patients worldwide suffering from heart failure."
This victory marks a pivotal moment for Venus Medtech as it seeks to leverage its strengthened patent portfolio in expanding its reach in the medical devices sector, particularly in the minimally invasive cardiac solution market. The commitment to innovation is evident, with the company poised to support heart failure treatments effectively, thereby hoping to impact countless lives on a global scale.
The case revolved around U.S. Patent No. 10,702,385 (the ‘385 patent), which focuses on an innovative transcatheter valve-clamping and support structure designed for minimally invasive mitral and tricuspid valve therapies. Edwards initially challenged the validity of this patent on June 2, 2021, by requesting an inter partes review of the claims. However, on December 6, 2022, the PTAB ruled in favor of Cardiovalve, dismissing Edwards' claims of non-patentability due to insufficient evidence. The CAFC confirmed this ruling on June 9, 2025, reiterating the legitimacy of Cardiovalve’s patent assertions.
Background of the Legal Battle
The patent dispute highlights the critical advancements within Cardiovalve's technology, aiming to address significant issues in heart valve interventions. Cardiovalve's devices are engineered using groundbreaking technologies, including a self-expanding Nitinol stent designed to minimize paravalvular leakage and a flat stent structure that helps reduce the risk of left ventricular outflow tract (LVOT) obstruction. Moreover, its transfemoral-transseptal access offers a less invasive alternative to traditional approaches, improving patient recovery experiences.
In addition, Cardiovalve's innovative implantation process, which consists of three crucial steps—Positioning, Anchoring, and Releasing—is designed for improved reproducibility and precision.
Impact on Venus Medtech
The recent judgment not only fortifies Cardiovalve’s patent standing but also positions Venus Medtech as a pivotal player in the global cardiology market. Lim Hou-Sen, CEO of Venus Medtech, emphasized the significance of this ruling, stating, "This groundbreaking victory reaffirms the original innovations of Cardiovalve and demonstrates the integrity of global intellectual property systems. We remain committed to advancing structural heart therapies through clinically driven innovations."
Similarly, Amir Gross, CEO of Cardiovalve, expressed optimism regarding future developments, stating, "Our philosophy, ‘Innovation Never Stops’, has overcome technical barriers in mitral and tricuspid interventions. This four-year legal affirmation accelerates our global clinical strategy, which aims to provide superior solutions for the more than 40 million patients worldwide suffering from heart failure."
This victory marks a pivotal moment for Venus Medtech as it seeks to leverage its strengthened patent portfolio in expanding its reach in the medical devices sector, particularly in the minimally invasive cardiac solution market. The commitment to innovation is evident, with the company poised to support heart failure treatments effectively, thereby hoping to impact countless lives on a global scale.
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