#China #Edwards Lifesciences #Hangzhou #Venus Medtech #Cardiovalve

Legal Triumph for Cardiovalve Against Edwards Lifesciences

On August 5, 2025, Venus Medtech (Hangzhou) Inc., a notable player in cardiac technology, reported a significant legal victory for its subsidiary, Cardiovalve Ltd. This landmark decision came from the U.S. Court of Appeals for the Federal Circuit (CAFC), affirming the validity of Cardiovalve's patent against claims made by Edwards Lifesciences Corporation and Edwards Lifesciences LLC.

Background on the Legal Dispute

The ongoing battle revolved around U.S. Patent No. 10,702,385, covering a pioneering clamp and support structure for transcatheter heart valves, essential for minimally invasive therapies for mitral and tricuspid valves. On June 2, 2021, Edwards initiated an inter partes review challenging the validity of this patent, which sparked the legal proceedings. After extensive deliberations, the Patent Trial and Appeal Board (PTAB) ruled in favor of Cardiovalve on December 6, 2022, citing insufficient evidence from Edwards to prove the patent's invalidity.

Following Edwards's failure to request a rehearing before the legal deadline of July 16, 2025, the CAFC upheld the PTAB's decision, confirming Cardiovalve's patent rights.

Implications of the Ruling

This ruling not only solidifies Cardiovalve's patent portfolio but also enhances the global intellectual property protections for Venus Medtech. It significantly boosts the company's competitive position in the realm of structural heart diseases and positively impacts its strategic integrated platform, known as 'Quad-Valve'.

Mr. Lim Hou-Sen, CEO of Venus Medtech, expressed pride in this historic victory. He emphasized that it validates Cardiovalve’s innovative contributions to the cardiac field and reinforces the integrity of their global intellectual property systems. The company remains committed to advancing structural heart therapies through clinically-focused innovations.

Cardiovalve: Leading the Charge in Cardiac Solutions

Since its acquisition by Venus Medtech in January 2022, Cardiovalve has been integral in providing cutting-edge interventional solutions. Their latest product, a next-generation transcatheter valve replacement system, addresses issues related to mitral and tricuspid valve regurgitation. Key features include:

• - Nitinol Self-Expanding Stent: This dual-frame design minimizes paravalvular leaks, enhancing patient outcomes.
• - Low-Profile Endoprosthesis: Reduces the risk of left ventricular outflow obstruction during implantation.
• - Transfemoral-Transseptal Access: An innovative approach that ensures less invasive procedures compared to traditional transapical methods.
• - Adjustable Annular Sizing: Accommodates up to 55 mm sizes, fitting approximately 95% of patient anatomies.
• - Streamlined Three-Step Deployment: Position, Anchor, and Release method that promises high reproducibility and efficiency.

Mr. Amir Gross, CEO of Cardiovalve, highlighted the commitment to relentless innovation, which has allowed them to surmount technical challenges associated with mitral and tricuspid interventions. He believes this legal affirmation accelerates their comprehensive clinical strategy to deliver superior solutions for over 40 million patients suffering from valve regurgitation worldwide.

Conclusion

The ruling in favor of Cardiovalve sets a precedent in the competitive landscape of cardiac medical technology. As they continue to innovate, Cardiovalve strives to enhance patient care while solidifying its foothold as a leader in the industry. With a robust patent backing, they are poised to maintain a competitive edge as they roll out their advanced cardiac solutions globally.