The American College of Cardiology (ACC) has announced five Late-Breaking Clinical Trial Sessions, two Late-Breaking Clinical Trial Deep Dive Sessions, and three Featured Clinical Research sessions to be presented during its annual scientific session, “ACC with WCC,” or ACC.23/WCC to be held March 4-6 in New Orleans, LA.
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 Presents Pivotal Data on its Novel BACE Device at AATS Annual Meeting
Late-breaking oral presentation highlights significant reduction in Functional Mitral Regurgitation (FMR) and left ventricular stabilization
Data presented support recently granted CE Mark for treatment of FMR in EU
Study lays groundwork for second clinical trial and potential U.S. indication for heart failure
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CARY, N.C., April 30, 2021 /PRNewswire/ Phoenix Cardiac Devices, Inc., an innovator in cardiovascular medical device research and development, today presented pivotal data for its BACE™ (Basal Annuloplasty of the Cardia Externally) device, a novel modality for the treatment of Functional Mitral Regurgitation (FMR), at the virtual American Association for Thoracic Surgery (AATS) 101
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