#China #Hangzhou #Venus Medtech #Cardiovalve #Edwards

Legal Victory for Cardiovalve

In a recent legal development, Cardiovalve, a wholly-owned subsidiary of Venus Medtech (Hangzhou) Inc., achieved a decisive victory in its ongoing patent dispute against Edwards Lifesciences Corporation and Edwards Lifesciences LLC. The United States Court of Appeals for the Federal Circuit (CAFC) issued a formal decree in case 23-1515, upholding a previous ruling from December 2022 by the Patent Trial and Appeal Board (PTAB). This ruling confirmed the validity of Cardiovalve's patent, following Edwards' failure to file a timely petition for reconsideration before the legal deadline of July 16, 2025.

This outcome not only affirms Cardiovalve's critical patent portfolio but also enhances the global intellectual property protection for Venus Medtech, thereby bolstering its competitive stance in the structural heart disease market. The firm's strategic platform, known as “Quad-Valve,” stands to benefit significantly from this legal reinforcement.

Background of the Case

The dispute revolved around the validity of U.S. Patent No. 10,702,385, commonly referred to as patent 385. This patent is crucial as it encompasses an innovative transcatheter valve support and fixation structure, designed for minimally invasive therapies targeting both the mitral and tricuspid valves.

On June 2, 2021, Edwards initiated an inter partes review of claims 1 to 10 of the patent. However, the PTAB ultimately ruled in favor of Cardiovalve, acknowledging that Edwards could not substantiate their claims of unpatentability with sufficient evidence by December 6, 2022. Following this, the CAFC reaffirmed the PTAB’s decision on June 9, 2025, validating Cardiovalve’s patent claims.

About Cardiovalve

The acquisition of Cardiovalve by Venus Medtech in January 2022 marked a significant milestone in the company’s strategy to develop a comprehensive product portfolio and acquire essential technologies. Cardiovalve’s state-of-the-art transcatheter valve replacement system is specifically engineered to address mitral and tricuspid insufficiencies. Notably, it features:

• - Dual Structure Nitinol Self-Expanding Stent: This design minimizes paravalvular leaks significantly.
• - Low-Profile Stent Design: It helps reduce the risk of blocking the left ventricular outflow tract (LVOT).
• - Transfemoral-Transseptal Access: Offers a less invasive alternative compared to transapical approaches.
• - Large Annular Sizing Capacity: It accommodates up to 55 mm, suitable for about 95% of patient anatomies.
• - Simplified Three-Step Implementation: This involves positioning, anchoring, and releasing, ensuring exceptional reproducibility in procedures.

Statements from Leadership

Lim Hou-Sen, the CEO of Venus Medtech, expressed: “This historic victory validates Cardiovalve’s original innovations and demonstrates the integrity of global intellectual property systems. We remain dedicated to advancing structural heart therapies through clinically-driven innovation.”

Amir Gross, CEO of Cardiovalve, remarked: “Our philosophy of ‘Innovation Without Limits’ has overcome technical barriers in mitral and tricuspid interventions. This legal affirmation, after four years, propels our global clinical strategy to provide superior solutions to over 40 million heart failure patients worldwide.”

In conclusion, the outcome of this legal battle not only secures Cardiovalve's competitive edge in the market but also underscores the importance of robust patent protections in fostering innovation and advancing medical technology.