ArticleRegenerative biomaterials2024
Regulatory science promotes the translation of transcatheter tricuspid valve repair/replacement devices.
Article in Regenerative biomaterials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Fluid-structure interaction analysis of aortic valve dynamics: effects of aspect ratio.Regenerative biomaterials · 2026Article
- Biodegradable polymeric occluder with controllable locking structure for closure of atrial septal defect via interventional treatment.Regenerative biomaterials · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For patients with symptomatic and severe tricuspid regurgitation but inoperable with open surgery, transcatheter tricuspid valve intervention (TTVI) is a procedure of great clinical value. TTVI products include repair and replacement devices. TTVI products are one of the hotspots of investigation now, with different innovative biomaterials and structural designs in trials to satisfy divergent indications and reduce complications. With the emerging biomaterials, the technical difficulty of structural design will be greatly reduced, spurring further product innovation and development. The innovativeness and complexity of TTVI products have brought challenges to academia, industry, and regulatory agencies. Regulatory science provides a bridge to address these difficulties and challenges. This perspective article introduces the latest development of the TTVI products. With traditional methods, regulatory agencies face challenges in evaluating the safety and efficacy of TTVr/TTVR devices given the uncertainty of clinical use and the diversity of innovative structural design. This perspective article analyzes the regulatory challenges and discusses regulatory science that can be developed to assess the safety, efficacy, quality and performance of such products: including new approaches for innovative devices, pre-review path, computer modeling and simulation, accelerated wear testing methods for transcatheter heart valves and evidence-based research. This article reveals for the first time how to apply regulatory science systematically to TTVI products, which is of great relevance to their development and translation.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.