Venus Medtech Completes Enrollment in PREVAILS Pivotal Trial for Fully Retrievable TAVR Device Venus-PowerX
核心洞察
Venus Medtech (搜索) has completed patient enrollment in the PREVAILS study, a pivotal confirmatory trial for the Venus-PowerX transcatheter aortic valve system (搜索) in patients with severe aortic stenosis (搜索).
Venus-PowerX is the world's first self-expanding dry-valve TAVR device capable of full retrieval even after 100% deployment, with real-world data already emerging from Argentina, Chile, and Venezuela.
Data from the single-arm, objective-performance-criterion trial will support simultaneous regulatory submissions to China's NMPA and for CE marking in Europe under the stricter EU MDR 2017/745 framework.
Venus Medtech (搜索) (Hangzhou) Inc. has completed patient enrollment in the PREVAILS study, a pivotal confirmatory clinical trial evaluating the Venus-PowerX Transcatheter Aortic Valve System (搜索) in patients with severe aortic stenosis (搜索). The milestone, announced July 23, 2026, positions the company for simultaneous regulatory submissions to China's National Medical Products Administration (NMPA) and for CE marking in Europe under the EU Medical Device Regulation 2017/745.
The Venus-PowerX represents what the company describes as the world's first self-expanding dry-valve TAVR device capable of full release and complete retrieval — even after 100% deployment. The device has already secured regulatory approvals in Argentina, Chile, and Venezuela, making it the first commercially available fully recoverable self-expanding dry-valve TAVR product globally.
Trial Design and Strategic Significance
The PREVAILS study (Pivotal Study of Severe Aortic Stenosis (搜索) TREated with the Venus‑PowerX TrAnscatheter AortIc VaLve System) is a prospective, multicenter, single-arm, objective-performance-criterion trial. This design represents the standard architecture for TAVR pivotal studies, though success depends critically on endpoint selection and comparator benchmarks.
Data generated from PREVAILS will form the clinical package supporting regulatory submissions in both China and Europe. The Latin American commercial footprint adds a distinctive dimension: real-world clinical data from Argentina and Chile are already generating evidence on the retrieval mechanism under actual procedural conditions, allowing the regulatory dossier to arrive with an outcomes narrative already attached.
Device Features and Technological Differentiation
Venus-PowerX incorporates multiple proprietary technologies that distinguish it from currently marketed TAVR platforms. The most consequential feature is the ability to fully retrieve the device even after 100% deployment — a capability that, according to the company, no currently marketed self-expanding TAVR platform replicates in its exact configuration. This is enabled by a wire-controlled release mechanism.
Additional features include the Venus Endura Dry Tissue with anti-calcification treatment, which addresses documented durability concerns that have shadowed tissue-based TAVR valves over long-term follow-up — a consideration of growing importance as indications trend toward younger patients. The device also incorporates the Seadapt Self-Adaptive Anti-PVL Skirt, a V-shaped outflow design, and three radiopaque markers for enhanced procedural visualization.
"The successful completion of enrollment in the Venus-PowerX confirmatory trial positions this device as a significant addition to our TAVR portfolio," said Mr. Ma Renzheng, Chief Technology Officer of Venus Medtech (搜索). "We are committed to offering patients with severe aortic stenosis (搜索) a more precise, safer, and more controllable treatment option, and to advancing structural heart intervention from 'partially controllable' to 'fully controllable' at every step of the procedure."
Commercial Landscape and Competitive Dynamics
The commercial context into which Venus-PowerX seeks entry is dominated by established players. Edwards Lifesciences (搜索) generated $4.5 billion in TAVR sales in 2025 and holds over 60% of the global market, with Medtronic occupying most of the remaining share. Displacing either company in Europe or China requires more than a retrievability claim — it demands a procedural safety signal compelling enough to change implanter behavior.
The critical metric to watch when PREVAILS data read out will be the rate of device repositioning or retrieval actually used during procedures. If operators deploy the feature at a clinically meaningful frequency and achieve acceptable outcomes, Venus Medtech (搜索) has a genuine differentiation story. If retrieval remains a theoretical backstop almost never invoked, the valve competes on conventional metrics where incumbents hold structural advantages.
PREVAILS will need to demonstrate that the full-retrieval mechanism translates into measurably fewer paravalvular leak corrections, positioning failures, or reinterventions — not merely that retrieval is mechanically possible.
About Venus Medtech (搜索)
Venus Medtech (搜索) (02500.HK) is a structural heart disease innovator with a comprehensive product pipeline covering all four heart valves — TAVR, TPVR, TMVR, and TTVR — and related accessory products. The company maintains global R&D centers in China, the United States, and Israel.