The Fully Recoverable Heart Valve: A New Era of Control in Cardiac Care

HANGZHOU, China – July 23, 2026 – A critical milestone has been reached in the quest to make one of medicine’s most delicate procedures safer and more precise. Venus Medtech today announced the completion of patient enrollment for the pivotal Chinese trial of its Venus-PowerX, the world's first self-expanding heart valve system that can be fully deployed, evaluated, and then completely retrieved if necessary. This development doesn't just inch a new device closer to the market; it signals a fundamental shift in how surgeons approach structural heart disease, moving the complex procedure from “partially controllable” to “fully controllable.”

The completion of the PREVAILS study paves the way for the Hangzhou-based company to seek simultaneous regulatory approval in China and Europe. Following earlier approvals in Latin America, this move positions Venus Medtech not just as a domestic champion but as a formidable player on the global stage, challenging a multi-billion-dollar market long dominated by American and European giants.

A New Paradigm of Precision

For patients with severe aortic stenosis—a life-threatening narrowing of the heart's main outflow valve—transcatheter aortic valve replacement (TAVR) has been a game-changer. This minimally invasive procedure allows a new valve to be inserted via a catheter, avoiding the risks of open-heart surgery. However, the procedure has always carried an inherent tension: once a valve is substantially deployed, the decision is largely irreversible. Misplacement or a suboptimal fit could lead to complications like paravalvular leakage (PVL), where blood leaks around the new valve, a condition linked to poorer long-term outcomes.

The Venus-PowerX system is engineered to solve this very problem. Its standout feature is its 100% recoverability. For the first time, an interventional cardiologist can fully deploy the self-expanding valve, assess its fit and function within the patient’s anatomy, and if the position is anything less than perfect, fully recapture and retrieve it without surgical intervention. This capability effectively provides an “undo button,” a level of control previously unattainable.

“The unique wire-controlled design that allows for 100% retrieval and redelivery of the valve after complete release is particularly important to challenging TAVR cases,” noted one leading interventional cardiologist who has used the device in early studies. This precision is critical for ensuring optimal outcomes and minimizing procedural risk.

Beyond its unique mechanics, the system incorporates several other forward-thinking technologies. The valve itself is made from Venus Endura™, a proprietary dry-tissue technology that undergoes an anti-calcification treatment. Unlike conventional valves that must be stored in aldehyde solutions, this dry valve can be stored at room temperature, simplifying hospital logistics and eliminating potential tissue toxicity. The company claims this process enhances the valve’s long-term durability, a crucial factor for patients who hope for a lifelong solution. Furthermore, the device includes a Seadapt™ self-adaptive skirt, a polymer material designed to intelligently fill gaps between the valve and the native tissue, actively preventing paravalvular leaks.

A System of Global Innovation

The development of Venus-PowerX is not an isolated success but a reflection of a deliberate and systematic global strategy. While the pivotal PREVAILS study was conducted in China, Venus Medtech has already secured regulatory approval and begun commercial use of the device in Argentina, Chile, and Venezuela. This Latin American beachhead has served as a crucial proving ground, generating real-world clinical evidence that supports its case for wider adoption in the larger, more lucrative markets of Europe and China.

The global TAVR market, projected to exceed $11 billion by the early 2030s, has been the domain of industry titans like Edwards Lifesciences and Medtronic. Venus Medtech is positioning itself as a serious challenger by building an innovation ecosystem that spans the globe, with R&D centers in China, the United States, and Israel. This global footprint allows the company to develop a comprehensive pipeline of solutions for all four heart valves, including other next-generation devices like the Venus-Vitae TAVR system and the VenusP-Valve for pulmonary valve replacement, which has already earned CE marking in Europe and approval in Canada.

The company's simultaneous pursuit of NMPA approval in China and CE marking in Europe is a bold and efficient strategy. It demonstrates confidence in the device's clinical data and an understanding of the complex, rigorous regulatory pathways in both jurisdictions. Success would not only open up massive patient populations but also validate the company's R&D model and its ability to compete at the highest level.

Redefining the Patient Journey

For the millions of people worldwide living with the debilitating symptoms of aortic stenosis—chest pain, fatigue, and shortness of breath—these technological advancements translate into tangible hope. A safer, more precise procedure means a lower risk of immediate complications and a higher chance of a successful, long-lasting outcome.

“We are committed to offering patients with severe aortic stenosis a more precise, safer, and more controllable treatment option,” said Mr. Ma Renzheng, Chief Technology Officer of Venus Medtech. This commitment to full procedural control aims to directly improve the patient journey, from reducing time in the operating room to enhancing long-term quality of life.

With the PREVAILS study now fully enrolled, the medical community awaits the full data readout. The results will be critical in determining the device's future in Europe and China. If the data confirms the promise shown in early use, the Venus-PowerX system could soon become a new standard of care, marking a significant step forward for patients and a defining moment for the rise of global medtech innovation from China.