Tenders Are Invited For Cardiac Valve – Transcatheter Pulmonary Valve With Adaptive Presten

Cardiac Valve – Transcatheter Pulmonary Valve With Adaptive Presten. Basic Technical Requirements For The Subject Of The Procurement Transcatheter Pulmonary Valve System With Adaptive Prestent Intended For Transcatheter Pulmonary Heart Valve Replacement With A Balloon-Expandable Bioprosthesis Using A Minimally Invasive Transfemoral Approach, Indicated For The Treatment Of Patients With Severe Pulmonary Regurgitation. The Technical Design Of The System Includes: - Balloon-Expandable Bioprosthesis - Self-Expanding Adaptive Prestent With A Minimum Height Of 49 Mm Designed To Create A Landing Zone Consisting Of: O Nitinol Structure, O Cover Made Of Polyethylene Terephthalate Fabric Fixed With Stitches On The Inner Side Of The Structure, O Inlet (Inflow) Part Ensuring Sealing Of The System With An Outer Diameter Of Min. 39 Mm, With An Outflow Part With An Open Cell Structure Allowing Blood Flow With An Outer Diameter Of Min. 41 Mm, O Central Support Section Intended For Implantation Of A Balloon-Expandable Transcatheter Bioprosthesis, O Three Radiopaque Markers Located In The Central Narrowed Part Of The System To Ensure Imaging Identification During Implantation, O Two Triangular Fixation Handles On The Proximal Part Intended For Connection To The Delivery System - System Compatible With Transcatheter Heart Valve Size 29 Mm - System Compatible With Mr Conditional (1.5T/3.0T) - Medical Equipment Meeting The Requirements Of Eu Mdr 2017/745 And Ce Marking