On Average, 41% More Sensitive Than Current Tests for Predicting Future Heart Disease in Women CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics, Inc, a biotechnology company making cardiovascular disease prevention and early detection more accessible, personalized and precise, announces the launch of its patent-pending flagship product, Epi+Gen CHD. The Epi+Gen CHD test sensitively assesses […]
Coronary/Structural Heart
PhaseBio Presents Data from Phase 1b/2a Trial of Pemziviptadil for the Treatment of Pulmonary Arterial Hypertension at 15th Pulmonary Vascular Research Institute Virtual World Congress
New data for pemziviptadil (PB1046) support continued evaluation as a potential novel therapy of once-weekly VIP analogue for adults with pulmonary arterial hypertension; novel agent observed to be well tolerated, with no drug-related serious adverse events resulting in study drug discontinuation MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a […]
Ancora Heart Enrolls First Patient in the CORCINCH-HF Study
Pivotal Trial to Evaluate Safety and Efficacy of AccuCinch® Ventricular Restoration System in Heart Failure Patients with Reduced Ejection Fraction SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced enrollment of the first patient in the CORCINCH-HF pivotal trial, which is designed […]
Valcare Medical Announces First-in-Human Transseptal Implant of the AMEND™ Annuloplasty Ring for Mitral Valve Repair
HERZLIYA, Israel, Jan. 27, 2021 /PRNewswire/ — Valcare Medical Ltd. developer of transcatheter mitral and tricuspid valve repair and replacement solutions, announces that it has successfully completed its first-in-human transseptal delivery of the AMEND™ annuloplasty ring. The transseptal AMEND procedure was performed at the Schulich Heart Centre at Sunnybrook Health Sciences Centre in Toronto, under […]
Microbot Medical Announces Successful Outcome of its Discussions with FDA Regarding Regulation of Self-Cleaning Shunt
FDA Feedback Reflects Strength of Pre-Clinical Safety Data; Maintains Q3 2022 Projected Commencement of First-in-Human Clinical Trial HINGHAM, Mass., Jan. 27, 2021 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) announced the completion of successful discussions with the U.S. Food and Drug Administration (FDA) for its Self-Cleaning Shunt (SCS). After review […]
Elixir Medical Announces Outstanding 24-month Data for DynamX Coronary Bioadaptor System, Demonstrating Strong Safety With No Target Lesion Revascularization, Myocardial Infarction or Thrombosis Through 24 Months
Successful DynamX Bioadaptor Live Case Presented at Singapore Live MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced the 24-month clinical results for the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. The results were presented at the 30th Annual Live […]
Foldax Biopolymer Shown to Possess Ideal Properties for Heart Valve in New Published Paper
Company’s LifePolymer Material Used in First Polymer Heart Valves Ever Approved by FDA for Use in Clinical Trials SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of a research paper in Advanced NanoBiomed Research that concluded that its LifePolymer™ biopolymer “exhibits ideal biomaterial properties for the flexible leaflets of a totally synthetic […]
Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology
Innovative technology offers an implant-free approach for individuals with chronic heart failure AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial […]
Individual patient data meta-analysis of the effects of the CARILLON® mitral contour system
ESC Heart Failure Giallauria et al. December 2020 An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled 209 heart failure patients with reduced ejection fraction patients and functional mitral regurgitation (FMR). Patients implanted with the Carillon Mitral Contour System or control were assessed for 12-month outcomes […]
Abbott Receives Expanded Medicare Reimbursement for First-Of-Its-Kind MitraClip™ Device
– New national reimbursement enables access to transcatheter mitral valve repair procedures with MitraClip for people with secondary mitral regurgitation, significantly expanding the eligible patient population ABBOTT PARK, Ill., Jan. 20, 2021 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) revised its National Coverage Determination (NCD) […]



