Key result
Regulatory science tools like computer modeling and wear testing address evaluation challenges for innovative TTVI devices.
Why the study?
The innovativeness and complexity of TTVI products pose challenges to regulatory agencies in evaluating safety and efficacy using traditional methods.
Applying regulatory science systematically to transcatheter tricuspid valve intervention products is crucial for addressing the challenges of evaluating their safety and efficacy during development and translation.
May guide TTVI device regulatory evaluation; leaves open prospective validation before clinical adoption.
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.
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Cheng et al. (2024) conducted a review in Symptomatic and severe tricuspid regurgitation. Transcatheter tricuspid valve intervention (TTVI) was evaluated. Systematic application of regulatory science, including computer modeling and accelerated wear testing, can address challenges in evaluating the safety and efficacy of innovative TTVI devices.
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