Coronary/Structural Heart

Attune Medical’s ensoETM™ Granted FDA De Novo Marketing Authorization to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting from Radiofrequency Cardiac Ablation Procedures

CHICAGO–(BUSINESS WIRE)–Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. “Our lab has published studies showing a 30 percent reduction in procedure time and a 14 percent […]

MedAlliance Announces Enrollment of over 1,660 Patients in Landmark SELUTION DeNovo Study

GENEVA, Sept. 14, 2023 /PRNewswire/ — MedAlliance has announced enrollment of over 1,660 patients in its ground-breaking SELUTION DeNovo coronary randomized study. Recruitment is now half way towards a planned 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon (SELUTION SLR), versus any limus drug-eluting stent (DES). […]

CorVista Health Announces FDA Clearance of the Novel CorVista System to Detect the Presence of Cardiac Disease

WASHINGTON–(BUSINESS WIRE)–CorVista Health, Inc., a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the FDA clearance of the CorVista System® with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis. “CorVista Health’s innovative solution has the potential […]

New Study Confirms HeartFlow FFRCT Leads to Improved Patient Outcomes

CLEVELAND – A diagnostic test, first offered in the United States at University Hospitals (UH) Harrington Heart & Vascular Institute, has now shown through a clinical study to significantly decrease cardiovascular mortality, reduce additional non-invasive heart testing, and increase cath lab efficiency. These results show a promising, new approach that […]

Heartseed Announces the Presentation of HS-001, an Investigational Stem Cell-Derived Therapy for the Treatment of Advanced Heart Failure at the 71st Annual Meeting of the Japanese College of Cardiology

TOKYO–(BUSINESS WIRE)–Heartseed (Heartseed Inc.), a Tokyo-based biotechnology company developing iPSC-derived cardiomyocytes for heart failure, today announced that the case reports of two patients in the Phase 1/2 clinical trial (LAPiS Study) of HS-001 in combination with coronary artery bypass grafting surgery for advanced heart failure, was presented by the investigator […]

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Exploratory post-hoc analysis of STELLAR shows potential of sotatercept to improve cardiovascular function Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy Nine Merck-sponsored abstracts […]

Procyrion Secures New Medicare Payment Codes Applicable to its Aortix™ Percutaneous Mechanical Circulatory Support Technology

HOUSTON, Sept. 7, 2023 /PRNewswire/ — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today it has successfully secured new inpatient hospital ICD-10-PCS procedure codes applicable to its Aortix™ percutaneous mechanical circulatory support (pMCS) technology. The new codes represent a significant milestone as […]

Cardio Diagnostics Holdings, Inc Partners with Ascension Borgess Hospital’s Heart Attack Prevention Clinic on Coronary Artery Disease Study

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, today announced its AI-driven Epi+Gen CHD and PrecisionCHD tests will be leveraged in a research study led by Dr. Vishal Gupta, a cardiologist and the head of the Heart Attack Prevention Clinic at Ascension Borgess. […]

Cytokinetics Announces Start of ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

SOUTH SAN FRANCISCO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), is open to enrollment. Aficamten is a next-in-class cardiac myosin inhibitor in development for the […]

BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial

SUNNYVALE, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP® Cell Therapy […]