Coronary/Structural Heart

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System

BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ — Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This innovative heart valve has been granted Breakthrough Device designation for the proposed indication of treatment of severe […]

Anteris Technologies Announces First Successful Implantation of DurAVR™ THV in a Valve-in-Valve Procedure

BRISBANE, Australia & MINNEAPOLIS–(BUSINESS WIRE)–Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR), a structural heart company developing DurAVR™ THV, a new class of biomimetic heart valve and the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic the performance of a native human aortic valve, announces that the DurAVR™ […]

Ionis completes enrollment in landmark Phase 3 CARDIO-TTRansform study in patients with TTR-mediated amyloid cardiomyopathy

CARLSBAD, Calif., July 31, 2023 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced the completion of enrollment in the Phase 3 CARDIO-TTRansform cardiovascular outcomes study of eplontersen in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a large and growing patient population at risk of life-threatening cardiovascular (CV) events. The study enrolled more than 1,400 patients. […]

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

THE WOODLANDS, Texas and REGENSBURG, Germany, Aug. 1, 2023 /PRNewswire/ — The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared […]

New Data from Clinical Studies Further Validate HeartFlow’s All-in-One Portfolio of Precision Coronary Care Solutions

MOUNTAIN VIEW, Calif., July 28, 2023 (GLOBE NEWSWIRE) — Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of coronary computed tomography angiography (CCTA)-based precision coronary care technologies. Study results were presented at the Society of Cardiovascular Computed Tomography (SCCT) Conference in […]

Ionis expands eplontersen agreement with AstraZeneca to include exclusive rights in Latin America

CARLSBAD, Calif., July 28, 2023 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced it has expanded its existing collaboration with AstraZeneca to include exclusive rights for AstraZeneca to commercialize eplontersen in Latin America. Ionis previously granted AstraZeneca exclusive rights to commercialize eplontersen in all other countries outside the U.S. Ionis and AstraZeneca will continue to jointly […]

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

THE WOODLANDS, Texas and REGENSBURG, Germany, July 25, 2023 /PRNewswire/ — The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared […]

Cleerly and Cenegenics Partner to Offer Heart Disease Prevention Technology as Part of Performance Health Age Management Portfolio

DENVER – JULY 18, 2023 — Cleerly, the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease, today announced a partnership with Cenegenics, a leading performance health age management platform dedicated to helping people achieve their peak cognitive, physical and metabolic health. Through […]

BioCardia Announces DSMB Recommendation to Pause New Enrollment in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial While Additional Blinded Data is Collected

SUNNYVALE, Calif., July 24, 2023 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP® Cell Therapy Heart […]