FDA Grants Break Through Device Designation for TricValve Transcatheter Bicaval Valves System
Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products + Features GmbH TricValve Transcatheter Bicval Valves System. The system uses two self-expanding valves in the vena cava for the treatment of patients with hemodynamically relevant tricuspid insufficiency without the need to touch the native tricuspid valve.
January 6, 2021 — The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products + Features GmbH TricValve Transcatheter Bicval Valves System.