Summary: First-in-Man Study Shows Promising Results for world’s first TAVR procedure New Fully Retrievable Valve.
Summary: First-in-Man Study Shows Promising Results for world’s first TAVR procedure New Fully Retrievable Valve.
Source: The American Journal of Cardiology – Click here to read the full analysis
Highlighted by AHA | April 2025
1. Background:
• Traditional self-expanding TAVR valves are only partially retrievable, which may result in malposition or valve migration during final deployment.
• The Venus-PowerX valve, developed by Venus MedTech (China), introduces a fully retrievable and repositionable mechanism even after 100% deployment.
2. Device Features:
• Wire-controlled system enables full recapture.
• Hourglass-shaped frame with supra-annular porcine pericardial leaflets.
• Radiopaque markers and sealing skirt to enhance placement accuracy and reduce paravalvular leak.
• Uses anti-calcification and dry-tissue technologies for long-term durability and room-temperature storage.
3. Study Design – First-in-Human Trial:
• 25 patients with severe aortic stenosis (mean age 75.3 years; 52% female).
• Conducted at two centers in China.
• 52% had bicuspid aortic valve.
• Valve recapture at 80% attempted in 32% of cases — all successful.
• Full recapture at 100% attempted in 8% — all successful.
• 100% procedural and technical success.
4. Outcomes:
• 30-day outcomes:
• 88% device success,
• 20% required permanent pacemaker (linked to RBBB, short membranous septum, 32-mm valve).
• No stroke, MI, valve thrombosis, endocarditis, or CV hospitalization.
• 1-year outcomes:
• 96% survival.
• No stroke, MI, or cardiovascular rehospitalization.
• One non-cardiac death (pneumonia).
• Mean AV gradient dropped from 56 mmHg to 11.6 mmHg.
• Effective orifice area improved from 0.6 cm² to 1.8 cm².
• Only 1 patient had moderate paravalvular leak.
5. Conclusion:
• Venus-PowerX enables precise positioning and reduces risk of migration, leak, and conduction disturbances.
• Dry-tissue technology enhances durability and ease of storage/use.
• Potential to expand TAVR accessibility to resource-limited settings.
• Larger studies are needed to confirm these early findings.
https://www.ajconline.org/article/S0002-9149(25)00200-0/fulltext
