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.
Cardiol Therapeutics Inc.: Cardiol Therapeutics Appoints Worldwide Clinical Trials as CRO for the Company s Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19
Oakville, Ontario (Newsfile Corp. - December 15, 2020) - Cardiol Therapeutics Inc. (
TSX: CRDL) (
Cardiol or the
Company ), a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease ( CVD ), announces that it has appointed contract research organization ( CRO ) Worldwide Clinical Trials ( Worldwide ), as the Company initiates it s Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the United States. The double-blind, placebo-controlled clinical trial is designed to investigate the efficacy and safety of CardiolRx, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or