Venus MedTech Prevails in Landmark Patent Victory Against Edwards Lifesciences, Bolstering Global Leadership in Structural Heart Therapies

Jul 24, 2025 16:30 CST Updated 16:30

Venus Medtech

Artificial Heart Valve System Device Developer

Cardiovalve

Transfemoral Mitral Valve Replacement System Developer

Venus Medtech (Hangzhou) Inc. ("Venus Medtech") has officially won the lawsuit regarding the validity of patent rights owned by its wholly-owned subsidiary, Cardiovalve Ltd. ("Cardiovalve"), against Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively referred to as "Edwards Lifesciences"). On July 16, 2025, following legal procedures and within the prescribed time limit, Edwards Lifesciences did not file a request for retrial. The United States Court of Appeals for the Federal Circuit ("CAFC") formally issued the mandate for the appeal case (Case: 23-1515) filed by Edwards Lifesciences against Cardiovalve's patents, upholding the final ruling made by the Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office in December 2022, which was in favor of Cardiovalve.This ruling marks Venus Medtech's successful defense of the validity of a key patent for Cardiovalve, strengthening its global intellectual property barriers and playing a significant role in consolidating its competitive advantage in the structural heart disease field, particularly in the "quad-valve integration" core valve business strategy.

Case Traceability

The case originated from Edwards Lifesciences' challenge to the validity of Cardiovalve's U.S. Patent No. 10,702,385, titled "Implant for Heart Valve" (the '385 patent). The patent covers an innovative technology for a transcatheter artificial heart valve clipping and support structure, applicable to minimally invasive treatments for mitral and tricuspid valves.

On June 4, 2021, Edwards Lifesciences petitioned the US PTAB to initiate an inter partes review (IPR) of claims 1-10 of the 385 patent (Case No. IPR2021-01051). On December 6, 2022, the PTAB issued a final written decision, granting Cardiovalve's motion to amend because Edwards Lifesciences failed to demonstrate by a preponderance of evidence that the substitute claims were unpatentable. On February 7, 2023, Edwards Lifesciences appealed the PTAB’s decision to the CAFC. On June 9, 2025, the CAFC issued its ruling, affirming the PTAB’s written decision and upholding the validity of the challenged claims of the 385 patent owned by Venus Medtech’s Cardiovalve.

Technological Breakthrough: Addressing Clinical Pain Points, Steadily Advancing Cardiovalve Clinical Trials

In January 2022, Venus Medtech completed the acquisition of Cardiovalve Ltd., an Israeli company. This significant move marks a milestone in the development history of Venus Medtech. It not only enriches its product pipeline in the mitral and tricuspid valve replacement fields but also acquires the platform technology possessed by Cardiovalve, which can be applied to the R&D of other innovative products of Venus Medtech in the future, providing strong support for its technological innovation and product upgrades. This helps the company continuously advance in the field of interventional valves and enhance its market competitiveness. The self-developed Cardiovalve is a transcatheter interventional valve replacement system suitable for both mitral and tricuspid regurgitation treatment. This innovative device adopts a self-expanding double-layer nitinol valve frame design, effectively reducing paravalvular leakage. Its unique short valve frame design reduces the risk of left ventricular outflow tract obstruction. Compared with similar products, its femoral vein access...The method significantly improved treatment safety. At the same time, the large annulus design of up to 55mm is suitable for approximately 95% of the patient population, greatly expanding the product's applicability.Scope. Cardiovalve is easy to operate, safe, and highly reproducible, requiring only three steps: positioning, anchoring, and releasing.

Looking Ahead: Innovation-Driven Development, Respect for Intellectual Property

Hao-Sheng Lin, General Manager and CEO of Venus Medtech

This victory marks a milestone for Venus Medtech in the high-end medical device field. The CAFC ruling not only validates the originality of Cardiovalve technology but also highlights the fair protection of innovation value by the international intellectual property system. Venus Medtech will continue to advance the global development of Cardiovalve, promoting progress in structural heart disease treatment with a focus on clinical value.

Mr. Amir Gross, CEO of Cardiovalve

Cardiovalve has always adhered to the concept of "Innovation never stops." Our team of engineers has overcome the technical barriers of minimally invasive treatment for mitral and tricuspid valves with disruptive original designs, and we have rigorously protected these innovative achievements through a global intellectual property rights strategy. This legal victory after a four-year judicial process is strong evidence of the value of our patent portfolio and our long-term commitment to innovation. We will continue to advance our global clinical development strategy as planned, providing better treatment options for tens of millions of patients with mitral/tricuspid regurgitation.