Coronary/Structural Heart

Saranas Successfully Completes Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today that it has completed enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird® Bleed Monitoring System. The Early Bird Bleed Monitoring System is the […]

Us2.ai Partners with Leading Academic Medical Center to Collaborate on AI-Enabled Echocardiography Software

SINGAPORE–(BUSINESS WIRE)–Us2.ai, a Singapore-based MedTech firm, has partnered with Duke University to co-develop and commercialize AI tools for echocardiography, to enable earlier detection, improved diagnosis and more efficient management of heart disease. “This advances Duke University’s efforts in digitalising clinical trials” Tweet this In clinical practice, echocardiography is now firmly established as […]

Edgewise Therapeutics Begins Dosing First-in-Human Phase 1 Trial of EDG-7500, its Lead Clinical Candidate for Hypertrophic Cardiomyopathy (HCM) and Other Serious Diseases of Cardiac Diastolic Dysfunction

BOULDER, Colo.–(BUSINESS WIRE)–Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other […]

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 […]