May 5, 2021
Novel device designed to address the root cause of mitral regurgitation, avoiding the need for open-heart surgery
Company seeks partner to conduct a pivotal study in pursuit of a heart failure indication
Clinical data supporting CE Mark to be presented as a late-breaking oral presentation at the virtual AATS 101st annual meeting
CARY, N.C., May 5, 2021 Phoenix Cardiac Devices, Inc. announced that it has received CE Mark for its BACE™ (Basal Annuloplasty of the Cardia Externally) device, a novel modality for the treatment of Functional Mitral Regurgitation (FMR). BACE is the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of FMR. The CE Mark serves as approval by the European Union (EU) to commercialize BACE. The supporting clinical data, showing significant efficacy in reduction of MR grade and size of the left ventricle that was sustained out to 24 months
Phoenix Cardiac Receives CE Mark for its Innovative BACE Device to Treat Functional Mitral Regurgitation
Company seeks partner to conduct a pivotal study in pursuit of a heart failure indication
Clinical data supporting CE Mark to be presented as a late-breaking oral presentation at the virtual AATS 101
st annual meeting
CARY, N.C., April 26, 2021 /PRNewswire/ Phoenix Cardiac Devices, Inc., an innovator in cardiovascular medical device research and development, today announced that it has received CE Mark for its BACE (Basal Annuloplasty of the Cardia Externally) device, a novel modality for the treatment of Functional Mitral Regurgitation (FMR). BACE is the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of FMR. The CE Mark serves as approval by the European Union (EU) to commercialize BACE. The supporting clinical data, showing significant efficacy in reduction of MR grade and size of the left ventricle that was