TORONTO, Aug. 25, 2021 /PRNewswire/ – Baylis Medical announced today the first clinical use of the VersaCross® Large Access Solution in Canada, to perform a Left Atrial Appendage Closure (LAAC) procedure. The new solution includes the world’s first 3-in-1 radiofrequency (RF) wire paired with a seamless shapeable dilator designed to optimize tissue dilation […]
Coronary/Structural Heart
CARMAT Announces the Second Center Implanting Its Total Artificial Heart in the United States
The implant was performed at UofL Health – Jewish Hospital by University of Louisville physicians within the framework of the U.S. Early Feasibility Study PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by […]
Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment of Symptomatic Severe Aortic Stenosis
Evolut™ FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment DUBLIN, Aug. 24, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut™ FX TAVR system. […]
Preliminary Dan-NICAD II results to be presented at ESC
Malmö, Sweden, August 23, 2021 Preliminary Dan-NICAD II results to be presented at ESC Acarix AB (publ) today announced that the preliminary results of the Dan-NICAD II study will be presented at the ESC congress on 27AUG2021. The Dan-NICAD II trial was initiated in January 2018 to assess non-invasive methods in patients referred to CCTA (Coronary Computed Tomography […]
Amarin Reports Data from REDUCE-IT® Showing VASCEPA®/VAZKEPA (Icosapent Ethyl) Significantly Reduces Ischemic Events in Patients with Prior Heart Attacks Presented in Late Breaking Science Session at ESC Congress 2021, Organized by the European Society of Cardiology
VASCEPA found in prespecified and post hoc analyses to reduce first and total primary endpoints by 26% and 35%, respectively, in patients with prior Myocardial Infarction DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 23, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that data adding to the growing body […]
Lexicon’s Sotagliflozin Demonstrates Additional Compelling Benefits in Reducing Cardiovascular Endpoints: Results from Soloist and Scored Trials
Rapid benefit of sotagliflozin supported by data from the SOLOIST and SCORED trials presented at ESC Congress 2021 – The Digital Experience, including: 33% absolute risk reduction in the composite cardiovascular endpoint in type 2 diabetes patients with acute decompensated heart failure (HF), with consistent results among patients with preserved […]
Cardiac Dimensions® Announces Launch of Its Optimized U.S. Pivotal Trial – The EMPOWER Trial
International Study to Evaluate Innovative Minimally Invasive Treatment for Heart Failure With Early-Stage Functional Mitral Regurgitation KIRKLAND, Wash., Aug. 20, 2021 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the launch of the U.S. […]
PIH Health Good Samaritan Hospital Offers First-of-Its-Kind Treatment for Heart Disease
WHITTIER, Calif., Aug. 19, 2021 /PRNewswire/ — PIH Health Good Samaritan Hospital has a new treatment option available for patients with severely calcified coronary artery disease. The new technology is a novel application of lithotripsy, sonic pressure waves or shockwave energy, which has been used for many years to safely break up kidney stones. […]
FDA Completes On-site Pre-Approval Inspection of Liquidia’s Morrisville, North Carolina Facility
No Form 483 observations were issued during 5-day inspection MORRISVILLE, N.C., Aug. 18, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has completed an on-site Pre-Approval Inspection (PAI) of its Morrisville, North Carolina facility in connection with the on-going review […]
CardioNXT wins FDA nod for heart treatment delivery platform
BOULDER, Colo., Aug. 18, 2021 /PRNewswire/ — CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping System™, Activate Software™, Sensor Enabled Axis Patient Patches™, and MultiLink Sensor Enabled Catheter™. The CardioNXT technology platform enables […]



