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HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation

Late-breaking Clinical Trials, Featured Clinical Research Sessions Announced for American College of Cardiology ACC 23/WCC

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.

Phoenix Cardiac Receives CE Mark for its Innovative BACE Device to Treat Functional Mitral Regurgitation; Pivotal Data Presented at AATS Annual Meeting

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

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 News provided by Share this article Share this article 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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