Transcatheter Pulmonary Valve with Adaptive Pre-Stent

Transcatheter pulmonary valve system with adaptive pre-stent: for transcatheter pulmonary heart valve replacement using a balloon-expandable bioprosthesis via a minimally invasive transfemoral approach, indicated for patients with severe pulmonary regurgitation. The system includes a balloon-expandable bioprosthesis and a self-expanding adaptive pre-stent with a minimum height of 49 mm for creating a landing zone. This consists of a nitinol structure, a polyethylene terephthalate fabric cover (secured with sutures on the inner side), an inflow part with a minimum outer diameter of 39 mm for system sealing, an outflow part with an open cell structure allowing blood flow with a minimum outer diameter of 41 mm, a central support section for implanting the balloon-expandable transcatheter bioprosthesis, three radiopaque markers located in the central constricted part of the system for imaging identification during implantation, and two triangular fixation tabs on the proximal part for connection to the delivery system. The system is compatible with a 29 mm transcatheter heart valve, is MR Conditional (1.5T/3.0T), and as a medical device, meets the requirements of EU MDR 2017/745 and carries the CE mark.

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