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...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 inno-vative biomaterials and structural designs in trials to satisfy di-vergent indications and reduce complications.With the emerging biomaterials,the technical difficulty of structural design will be greatly reduced,spurring further product innovation and devel-opment.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 effi-cacy 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.展开更多
基金supported by funding from the second batch(for research and translation pre-evaluation of innovative medical biomaterials)and the third batch(for research on performance and safety evaluation of innovative biomaterial medical devices)of the Chinese Drug Regulatory Science Action Plan of the National Medical Products Administration.
文摘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 inno-vative biomaterials and structural designs in trials to satisfy di-vergent indications and reduce complications.With the emerging biomaterials,the technical difficulty of structural design will be greatly reduced,spurring further product innovation and devel-opment.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 effi-cacy 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.
