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

Venus Medtech Secures Legal Victory for Cardiovalve

Venus Medtech (Hangzhou) Inc. has recently marked a significant milestone by achieving a decisive legal victory for its subsidiary, Cardiovalve Ltd., against the renowned medical device company, Edwards Lifesciences. This court decision was made by the United States Court of Appeals for the Federal Circuit (CAFC), which emphatically affirmed the validity of Cardiovalve’s patent. The ruling follows a failed attempt by Edwards Lifesciences to contest the patent during the inter partes review process, establishing Cardiovalve’s innovative contributions to structural heart disease therapies.

Background of the Patent Dispute

The case revolved around Cardiovalve's U.S. Patent No. 10,702,385, which pertains to an advanced transcatheter heart valve clamping and support structure specifically designed for minimally invasive mitral and tricuspid valve interventions. On June 2, 2021, Edwards Lifesciences initiated a challenge against the patent, seeking to invalidate claims related to the innovative technologies which underpin Cardiovalve's product offerings. The Patent Trial and Appeal Board (PTAB) later issued a Final Written Decision in December 2022, favoring Cardiovalve. They found that Edwards failed to meet the burden of proof required to demonstrate that the claims were unpatentable.

After Edwards neglected to file a petition for rehearing by the required deadline of July 16, 2025, the CAFC confirmed PTAB’s ruling, further validating Cardiovalve's patent claims.

This legal affirmation is instrumental not only in safeguarding Cardiovalve's intellectual property but also in enhancing Venus Medtech's competitive positioning within the global market for structural heart disease therapies.

Strategic Importance of the Victory

According to Mr. Lim Hou-Sen, the CEO of Venus Medtech, this victory underscores the integrity of intellectual property systems on a global scale and affirms Cardiovalve's original innovations. He expressed the company’s commitment to fostering advancements in structural heart therapies through clinically driven innovation. This sentiment was echoed by Mr. Amir Gross, CEO of Cardiovalve, who highlighted their philosophy of “Innovation Never Stops,” which pushes the boundaries of technology in treating mitral and tricuspid interventions.

The ruling represents a considerable boost not only for Cardiovalve's patent portfolio but also for the approximately 40 million patients worldwide suffering from regurgitation, a severe heart condition affecting the mitral and tricuspid valves. The advanced solutions developed by Cardiovalve, including the next-generation transcatheter valve replacement system, promise to deliver superior treatment outcomes by mitigating complications typically associated with traditional surgical methods.

Technological Innovations by Cardiovalve

Cardiovalve’s transcatheter valve replacement system exemplifies innovation with features designed specifically to reduce risks during mitral and tricuspid valve therapies:

• - Dual Frame Self-Expanding Nitinol Stent: This design minimizes paravalvular leakage, a common complication in transcatheter procedures.
• - Low-Profile Stent Design: This characteristic significantly lowers the risk of left ventricular outflow tract (LVOT) obstruction, a critical consideration during valve implantation.
• - Transfemoral-Transseptal Access: Offers a less invasive alternative to traditional transapical approaches, thus enhancing patient recovery times.
• - Large Annular Sizing Capacity: With the ability to accommodate valve sizes up to 55mm, this feature makes the device suitable for approximately 95% of patient anatomies.
• - Streamlined Three-Step Implantation Process: The Position-Anchor-Release method demonstrates remarkable reproducibility, contributing to the procedure's safety and effectiveness.

This technological prowess is further supported by Venus Medtech's strategic acquisition of Cardiovalve in January 2022, which aimed to consolidate its product portfolio and harness innovative heart therapies.

Conclusion

With this patent victory, Cardiovalve is well poised to accelerate its global clinical strategy for innovative therapies aimed at treating heart valve regurgitation. This case serves not only as a validation of Cardiovalve's technological advancements but also as a crucial step forward in protecting its intellectual assets in a highly competitive medical landscape. The commitment of both Venus Medtech and Cardiovalve to continuous innovation heralds a promising future for patients needing effective structural heart disease management solutions.