IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and […]
Coronary/Structural Heart
Conformal Medical Announces $9 million Series B Financing
NASHUA, N.H., Dec. 3, 2018 /PRNewswire/ — Conformal Medical, Inc., developer of the Conformal Left Atrial Appendage Seal for LAA occlusion, has secured $9 million in Series B funding. Conformal is developing proprietary seal technology for the prevention of stroke in patients with atrial fibrillation (AFib). Over five million people in the United States have AFib, […]
Micro Interventional Devices, Inc.™ Announces Continued Successful Enrollment in STTAR Trial
NEWTOWN, Pa., Nov. 29, 2018 /PRNewswire/ — Micro Interventional Devices, Inc.™ (MID) announced the continued successful enrollment of patients in STTAR (the Study of Transcatheter Tricuspid Annular Repair) being conducted in Europe. MID’s MIA™, Minimally Invasive Annuloplasty technology, is being studied for its safety and performance in the treatment of severe tricuspid regurgitation. MIA […]
Edwards Lifesciences and Medtronic Lead the U.S. TAVR Market, Despite Threat of New Competition – New Analysis from iData Research
VANCOUVER, British Columbia–(BUSINESS WIRE)–According to a new series of reports by iData Research, the United States cardiac surgery device market is valued at $5.7 billion USD and is forecast to exceed $10 billion by 2024. The largest segment of the cardiac surgery market is the transcatheter heart valve replacement (THVR) […]
Edwards’ SAPIEN 3 Ultra Transcatheter Heart Valve Receives CE Mark
IRVINE, Calif., Nov. 16, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients. “The SAPIEN 3 Ultra […]
CHF Solutions Launches Educational Webinar Discussing the Benefits of Aquadex FlexFlow® Therapy Following Cardiovascular Surgery with Cardiovascular Surgeon, Daniel Beckles, M.D., Ph.D.
EDEN PRAIRIE, Minn., Nov. 15, 2018 (GLOBE NEWSWIRE) — CHF Solutions, Inc. (Nasdaq: CHFS), today announces the launch of its new educational webinar featuring Daniel Beckles, M.D., Ph.D., director of Minimally Invasive Cardiothoracic Surgery at UHS Heart and Vascular Institute, Vestal, N.Y. The webinar can be accessed on the company’s […]
Terumo Cardiovascular Group Announces 510(k) Clearance for the CDI® Blood Parameter Monitoring System 550, Adding New Parameter for Oxygen Delivery
ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of oxygen delivery as one of 12 critical blood parameters. Oxygen […]
Bay Labs and Northwestern Enroll First Patient in Study Using AI to Improve Heart Disease Detection
Clinical Trial Evaluates if AI Helps Certified Medical Assistants Perform Echocardiograms and Detect Heart Disease in Primary Care Settings SAN FRANCISCO – November 13, 2018 – Bay Labs, a medical technology company at the forefront of applying artificial intelligence (AI) to cardiovascular imaging, andNorthwestern Medicine, which includes the #7 nationally […]
Aran Biomedical Pioneers Breakthrough Medical Textiles Valve Covering Technology; ValvTEX™
GALWAY, Ireland, Nov. 13, 2018 /PRNewswire/ — Aran Biomedical, a trusted partner in design, development and manufacture of implantable medical devices, today announced its new medical textile valve covering solution; ValvTEX™, for Mitral, Aortic and Tricuspid heart valves. The ValvTEX™ technology platform was created to reduce the delivery profile of transcatheter heart valves that require […]
Positive 12-Month Data on BioCardia’s Investigational CardiAMP Cell Therapy System for Heart Failure Presented at American Heart Association Scientific Sessions 2018
CHICAGO & SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced positive 12 month data for the roll-in cohort of its pivotal CardiAMP™ Heart Failure Trial studying the investigational CardiAMP Cell Therapy System in adult patients experiencing heart failure following a […]
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