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

Legal Victory for Cardiovalve

In a recent ruling, Venus Medtech (Hangzhou) Inc. celebrated a significant legal triumph for its fully-owned subsidiary Cardiovalve Ltd. This victory comes after a long-standing patent dispute with Edwards Lifesciences Corporation and Edwards Lifesciences LLC. The United States Court of Appeals for the Federal Circuit (CAFC) has upheld the validity of Cardiovalve's patent, specifically U.S. Patent No. 10,702,385, which covers an innovative heart valve technology designed for minimally invasive therapies.

Background of the Case

The legal battle was sparked in June 2021 when Edwards challenged the credibility of Cardiovalve's patent, specifically targeting claims 1-10 of the '385 Patent. The dispute focused on a unique clamping and support structure essential for transcatheter heart valve placements. After a detailed examination, the Patent Trial and Appeal Board (PTAB) ruled in December 2022 that Cardiovalve's claims were valid, as Edwards could not prove their position.

The recent decision by the CAFC confirmed PTAB's 2022 ruling, reinforcing the strength of Cardiovalve's intellectual property. Edwards was also unsuccessful in filing a petition for rehearing by the specified deadline of July 16, 2025, which solidified Cardiovalve's hold on its patent rights.

Implications for Venus Medtech

This ruling is not just a legal victory; it marks a pivotal moment for Venus Medtech in its mission to advance heart therapies. By solidifying Cardiovalve's patent, the company has substantially enhanced its position against competitors while also expanding its intellectual property portfolio globally. This outcome ensures that the innovative technologies developed by Cardiovalve can be effectively brought to the market, helping to address significant health issues related to structural heart diseases.

Cardiovalve’s Innovative Technology

Acquired by Venus Medtech in January 2022, Cardiovalve is at the forefront of creating next-generation transcatheter valve replacement systems. Their technology targets regurgitation issues in both mitral and tricuspid valves and introduces groundbreaking features:

• - Dual Frame Self-Expanding Nitinol Stent: This innovative design significantly minimizes paravalvular leakage, a common complication in valve replacement procedures.
• - Low-Profile Stent Design: This aspect reduces the risk of left ventricular outflow tract (LVOT) obstruction, enhancing patient safety during and after the procedure.
• - Transfemoral-Transseptal Access: This less invasive approach provides an alternative to the traditional transapical method, leading to improved recovery experiences for patients.
• - Large Annular Sizing Capacity: Capable of accommodating annular sizes up to 55mm, this technology effectively serves approximately 95% of patient anatomies.

The implantation procedure is streamlined into a three-step process: Position, Anchor, and Release, showcasing excellent reproducibility and efficacy levels.

Statements from Leadership

Mr. Lim Hou-Sen, the CEO of Venus Medtech, expressed his enthusiasm regarding this victory by reiterating the commitment to protecting innovations that can transform heart therapies. He emphasized the integrity of global intellectual property systems through this legal affirmation.

Mr. Amir Gross, CEO of Cardiovalve, highlighted the company's philosophy of continuous innovation and the importance of overcoming technical challenges in the cardiovascular field. This legal affirmation not only shields their intellectual property but also accelerates their clinical strategies to deliver high-quality solutions to the millions suffering from regurgitation issues worldwide.

Conclusion

This legal triumph not only serves as a protective milestone for Cardiovalve's innovations but also underscores Venus Medtech's dedication to leading in the structural heart landscape. The reinforcement of Cardiovalve's patent opens new avenues for clinical trials and the development of advanced heart therapies, ultimately aiming to improve the lives of patients across the globe.