Coronary/Structural Heart

HighLife Receives CE Mark Approval for its TMVR Solution

Paris, France, January 26, 2026 – HighLife SAS, a leading MedTech company focused on transcatheter solutions for structural heart disease, today announced that it has received CE Mark approval for the HighLife Transcatheter Mitral Valve Replacement (TMVR) System for the treatment of adult patients suffering from symptomatic moderate-severe or severe mitral valve regurgitation (MR), […]

The Lancet Publishes TRICORDER Study: Real-World Evaluation Shows Increased Detection When Eko AI-Enabled Stethoscopes Are Used in Primary Care

Large-scale NHS trial led by Imperial College London across 200+ NHS practices shows significant gains in early cardiac disease detection through AI-assisted stethoscope exams SAN FRANCISCO, Jan. 29, 2026 /PRNewswire/ — Eko Health, a leader in AI-powered cardiac and pulmonary disease…

Natera Announces Completion of Enrollment in Randomized ACES-EMB Trial in Heart Transplantation

ACES-EMB is the first randomized-controlled trial to compare dd-cfDNA surveillance to routine biopsy in organ transplantation, highlighting the benefits of Prospera™ in organ rejection AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the completion of enrollment in ACES-EMB, the first randomized-controlled trial […]

ReDS-SAFE HF II Trial Initiated – Large Randomized Controlled Study to Expand Evidence for ReDS-Guided Heart Failure Management

MADRID, Jan. 28, 2026 /PRNewswire/ — The ReDS-SAFE HF II Trial, a large multicenter investigator-initiated randomized controlled study, funded by both the Instituto de Salud Carlos III and the Spanish Society of Cardiology, has officially commenced. The trial is designed to further…

Corify Care Introduces First Whole-Heart Mapping Technology, Delivering a Global View of Cardiac Arrhythmias in a Single Beat

MADRID, Jan. 28, 2026 /PRNewswire/ — Corify Care today announced a major breakthrough in cardiac electrophysiology with the publication of its proprietary Global Volumetric Mapping technology in Nature Communications Medicine. The publication marks the first system capable of mapping all…

Concept Medical Announces First Patient Enrollment in STARS DAPT Randomized Clinical Trial Evaluating Abluminus NP Polymer-Free DES

TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc., a global pioneer in innovative drug delivery technology, is proud to announce the successful enrollment of the first patients in the STARS DAPT (ST-Segment Elevation Myocardial InfArction treated with a Polymer-Free Sirolimus-based NanocarrieR Eluting Stent and a P2Y12 inhibitor-based Single Antiplatelet Strategy after a Short Dual Antiplatelet Therapy […]

CVRx Announces Initiation of BENEFIT-HF, a Landmark Heart Failure Trial Evaluating Barostim in Significantly Expanded Population

Study is Expected to Be One of the Largest Therapeutic Cardiac Device Trials in Heart Failure Ever Performed, and is Supported by CMS Category B IDE CoverageMINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim™ in a significantly expanded heart failure population. Barostim™ is an implantable device that delivers electrical signals to baroreceptors located on the carotid artery, increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure symptoms. Barostim™ received FDA approval in 2019 following its designation under the FDA’s Breakthrough Devices Program and is now commercially available in both the U.S. and Europe. The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. The BENEFIT-HF trial is designed to evaluate Barostim in patients with heart failure who: Remain symptomatic after receiving optimized guideline-directed medical and device therapies (GDMT)Have a left ventricular ejection fraction (LVEF)

January Issue of Journal of Cardiac Failure-Intersections Examines How Innovation, Advanced Mechanical Support, and Prescribing Design Are Reshaping Heart Failure Care

The third issue of the open-access journal showcases multidisciplinary heart failure research and the many intersections that shape patient care. WASHINGTON, Jan. 21, 2026 /PRNewswire/ — The January issue of Journal of Cardiac Failure-Intersections brings together new analyses and…