Summary: First-in-Man Study Shows Promising Results for world\u2019s first TAVR procedure New Fully Retrievable Valve.<\/p>\n
Source: The American Journal of Cardiology \u2013 Click here to read the full analysis
\nHighlighted by AHA | April 2025<\/p>\n
1. Background:
\n\u2022 Traditional self-expanding TAVR valves are only partially retrievable, which may result in malposition or valve migration during final deployment.
\n\u2022 The Venus-PowerX valve, developed by Venus MedTech (China), introduces a fully retrievable and repositionable mechanism even after 100% deployment.
\n2. Device Features:
\n\u2022 Wire-controlled system enables full recapture.
\n\u2022 Hourglass-shaped frame with supra-annular porcine pericardial leaflets.
\n\u2022 Radiopaque markers and sealing skirt to enhance placement accuracy and reduce paravalvular leak.
\n\u2022 Uses anti-calcification and dry-tissue technologies for long-term durability and room-temperature storage.
\n3. Study Design \u2013 First-in-Human Trial:
\n\u2022 25 patients with severe aortic stenosis (mean age 75.3 years; 52% female).
\n\u2022 Conducted at two centers in China.
\n\u2022 52% had bicuspid aortic valve.
\n\u2022 Valve recapture at 80% attempted in 32% of cases \u2014 all successful.
\n\u2022 Full recapture at 100% attempted in 8% \u2014 all successful.
\n\u2022 100% procedural and technical success.
\n4. Outcomes:
\n\u2022 30-day outcomes:
\n\u2022 88% device success,
\n\u2022 20% required permanent pacemaker (linked to RBBB, short membranous septum, 32-mm valve).
\n\u2022 No stroke, MI, valve thrombosis, endocarditis, or CV hospitalization.
\n\u2022 1-year outcomes:
\n\u2022 96% survival.
\n\u2022 No stroke, MI, or cardiovascular rehospitalization.
\n\u2022 One non-cardiac death (pneumonia).
\n\u2022 Mean AV gradient dropped from 56 mmHg to 11.6 mmHg.
\n\u2022 Effective orifice area improved from 0.6 cm\u00b2 to 1.8 cm\u00b2.
\n\u2022 Only 1 patient had moderate paravalvular leak.
\n5. Conclusion:
\n\u2022 Venus-PowerX enables precise positioning and reduces risk of migration, leak, and conduction disturbances.
\n\u2022 Dry-tissue technology enhances durability and ease of storage\/use.
\n\u2022 Potential to expand TAVR accessibility to resource-limited settings.
\n\u2022 Larger studies are needed to confirm these early findings.<\/p>\n