ArticleNPJ cardiovascular health2026
Development and preclinical results of a transcatheter aortic valve implant with novel polymeric leaflets.
Article in NPJ cardiovascular health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Innovation and Challenges in Materials for Transcatheter Aortic Valves.Journal of cardiovascular translational research · 2026Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Current transcatheter aortic valve implantation (TAVI) systems use glutaraldehyde-fixed tissue leaflets, which are prone to structural valve degeneration. Polymeric valves may improve durability, hemocompatibility, and manufacturability. We designed, produced, and evaluated a self-expanding nitinol-framed TAVI device with siloxane poly(urethane-urea) (SiPUU) leaflets and an electrospun SiPUU skirt. Bench testing included frame fatigue to 200 million cycles, hydrodynamics per ISO 5840-3, and flow visualization using particle image velocimetry. Biocompatibility was assessed per ISO 10993. Preclinical evaluation involved nine ovine implants with serial imaging and histology to 90 days. In vitro tests showed EOAs of 1.3-1.5 cm² and 1.7-2.1 cm² (21 and 24 mm annulus, respectively, simulating under expansion), regurgitant fraction <6%, and preserved coaptation. Six animals completed follow-up with stable hemodynamics, no hemolysis, no PVL at implant, and no calcification at explant. The SiPUU-based TAVI demonstrated favorable durability, hydrodynamics, and biocompatibility, supporting further testing and delivery refinement toward first-in-human evaluation. Clinical Trial: N/A.
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Registered trials
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