Transcatheter Mitral Valve Replacement with a Balloon-Expandable Bioprosthetic Valve with Dock via Transseptal Access

In table X2R, Replacement of Cardiovascular System, device value F Bioprosthetic Valve, Balloon-expandable with Dock, and body part value G Mitral Valve, were added to approach value 3 Percutaneous, to capture transcatheter mitral valve replacement with a balloon-expandable device via transseptal access. Body Part Approach Device/Substance/Technology Qualifier G Mitral Valve 3 Percutaneous F Bioprosthetic Valve, Balloon-expandable with Dock C New Technology Group 12 One example, the SAPIEN M3 Transcatheter Mitral Valve Replacement System, is indicated for treatment of mitral valve regurgitation and stenosis. The system consists of a tri-leaflet bovine tissue valve and a dock. The dock encircles the...

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