Fully Controllable! Venus Medtech's Next-Gen Recapturable Self-Expanding TAVR Valve Completes Clinical Enrollment, Benefiting Millions of Heart Patients

July 20, 2026

For an 82-year-old patient with severe aortic stenosis and multiple comorbidities, open-heart surgery is often out of the question. The traditional approach — cracking the chest, stopping the heart, sewing in a replacement valve — carries risks that many elderly, frail patients simply cannot survive. Until recently, even the less invasive transcatheter aortic valve replacement, or TAVR, left surgeons with a narrow margin for error: once the valve was fully deployed, there was no going back.

That calculus is changing. Venus Medtech (02500.HK), a Chinese medical device company based in Hangzhou, announced on Monday that its next-generation heart valve system, Venus-PowerX, has completed enrollment of all patients in its Chinese pivotal clinical trial — a milestone that brings the product closer to regulatory approval in both China and Europe.

Venus-PowerX is the world's first self-expanding dry valve system that can be fully recaptured and repositioned even after 100% deployment — giving surgeons what amounts to an undo button during one of cardiology's most delicate procedures.

The completion of patient enrollment in the PREVAILS trial marks the end of a development journey that began nearly a decade ago. It also signals Venus Medtech's ambition to reshape a global TAVR market long dominated by Edwards Lifesciences and Medtronic, two American giants that together control the lion's share of the roughly $5 billion annual market.

A Disease of Aging Populations

Severe aortic stenosis — a narrowing of the valve that controls blood flow from the heart's main pumping chamber — is among the most common heart valve diseases in the elderly. Globally, about 2% of people over 65 are affected, rising to 4% among those 85 and older. In China alone, with its rapidly aging population, there are an estimated 2 million symptomatic patients aged 65 and above.

Left untreated, the condition leads to chest pain, shortness of breath, fainting, heart failure, and sudden death. For years, surgical valve replacement was the only option. TAVR, which delivers a replacement valve via a catheter threaded through the femoral artery, transformed outcomes for high-risk patients who could not tolerate open surgery. But existing valves carried a persistent limitation: once fully released, the implant could not be repositioned. Even small errors in placement could cause paravalvular leak, valve migration, or embolization — complications that increase mortality and often require additional interventions.

'Full Control' From Start to Finish

Venus-PowerX addresses that limitation with a proprietary wire-controlled mechanism that allows the valve to be fully recaptured and repositioned at any point during deployment — even after it has been 100% expanded. In practical terms, this means the interventional cardiologist can deploy the valve, assess its position and function in real time, make fine adjustments to depth and alignment, and only finalize the implant once satisfied.

"This moves the field from 'partially controllable' to 'fully controllable,'" said Ma Renzheng, Venus Medtech's chief technology officer. He described the system as a potential cornerstone of the company's TAVR product lineup, offering patients with severe aortic stenosis a more precise, safer, and more predictable treatment.

The device incorporates several other engineering advances. Its Venus-Endura dry valve technology combines anti-calcification treatment, immunological deactivation, and three-dimensional force-controlled drying — allowing the valve to be stored at room temperature without cold-chain logistics, a significant operational advantage for hospitals in developing markets. A supra-annular design optimizes blood flow dynamics. An hourglass-shaped nitinol frame comes in four sizes to fit a wide range of valve annulus dimensions. A Sealadapt active sealing skirt reduces the incidence of paravalvular leak. And a pre-loaded delivery system shortens procedural preparation time.

Clinical Data That Demands Attention

The clinical evidence supporting Venus-PowerX has been building steadily. In April 2025, results from the device's first-in-human, or FIM, study were published in the American Journal of Cardiology, a peer-reviewed international cardiology journal.

The numbers were striking:

• A procedural success rate of 100%, with zero technical failures.
• A one-year all-cause survival rate of 96.0%.
• Zero strokes, myocardial infarctions, or cardiovascular readmissions at one year.
• Significant hemodynamic improvement: mean transvalvular gradients dropped substantially, and effective valve orifice area roughly doubled post-implantation.
• 79.1% of patients had no paravalvular leak or only trace amounts.

The PREVAILS pivotal trial — a prospective, multicenter, single-arm study with pre-specified performance targets — enrolled patients at leading cardiac centers across China. The principal investigator is Professor Chen Mao of Sichuan University's West China Hospital in Chengdu, where the world's first FIM case was also performed in December 2021. The trial's completion of full enrollment in July 2026 means the device has now cleared the most critical phase of its regulatory pathway.

The clinical data will be submitted simultaneously to China's National Medical Products Administration (NMPA) and to European regulators for CE marking — a dual-track strategy that, if successful, would give Venus-PowerX access to two of the world's largest medical device markets.

A Decade in the Making

The road to Venus-PowerX has been long. Venus Medtech began researching dry valve technology in 2016, targeting the limitations of conventional wet-stored valves — which require complex preservation solutions, have limited shelf life, and offer restricted repositionability. The company's R&D team spent years developing anti-calcification treatments, refining the wire-controlled recapture mechanism, and building a portfolio of proprietary technologies including the Venus-Endura dry membrane, the Sealadapt sealing skirt, and the pre-loaded delivery platform.

The first clinical proof came in December 2021, when Professor Chen Mao's team at West China Hospital performed the world's first FIM implantation of a fully recapturable self-expanding dry valve. Three years later, in December 2024, the PREVAILS pivotal trial was launched with its first patient enrollment at the same institution. The FIM data published in April 2025 provided the clinical foundation for the pivotal study, which has now reached its enrollment endpoint.

Going Global

Venus-PowerX is already being used outside China. The device has received regulatory approval in Argentina, Chile, and Venezuela — making it the first fully recapturable self-expanding dry valve TAVR product approved anywhere in the world. Real-world clinical data from Latin America has been accumulating, providing additional evidence for the company's global regulatory submissions.

The international footprint matters. For years, the high-end TAVR market has been an American stronghold, with Edwards Lifesciences' SAPIEN platform and Medtronic's CoreValve/Evolut system commanding the vast majority of global revenue. Venus-PowerX represents a direct challenge from a Chinese innovator — one that claims a meaningful technological advantage in full recapture capability.

Whether that advantage translates into commercial success in regulated markets like Europe and China will depend on the pivotal trial's long-term follow-up data and the rigor of the regulatory review. But for the estimated 2 million Chinese patients living with symptomatic severe aortic stenosis — and the millions more worldwide — the arrival of a valve that surgeons can deploy, adjust, and recapture at will is more than a technical achievement. It is, quite literally, a second chance.

Source: Venus Medtech official announcement