A transcatheter mitral valve clip with a central filler for mitral valve regurgitation

Abstract

Despite the advantages of transcatheter edge-to-edge repair (TEER) devices for treating mitral regurgitation, challenges such as difficulties in leaflet grasping and clip dislodgement remain in clinical practice. In this study, we present the first detailed disclosure of a novel transcatheter mitral valve clip, the DragonFly, highlighting its material composition, design features, and associated benefits. The valve clip is constructed of nickel-titanium alloy, stainless steel, cobalt-chromium alloy, and polyethylene terephthalate, incorporating adjustable arms, grippers, and a unique central filler. The central filler, made of nitinol, offers remarkable compressibility and shape recovery. The whole valve clip can endure over 400 million fatigue cycles and ensure a robust grasp on valve leaflets at varying angles. The clip presents sufficient grasping force to prevent valve dislodgement, and the adjustable design accommodates various patient anatomies. Comprehensive biocompatibility assessments confirmed adherence to ISO 10993 standards through in vitro and in vivo experiments, including large-animal studies. The results demonstrated that the valve clip successfully creates a stable double-orifice structure without negatively impacting cardiac hemodynamics and has good biocompatibility. Overall, the DragonFly valve clip constitutes a technological advancement in the field of minimally invasive interventions for mitral valve disease, offering more treatment options for high-risk patients.