Coronary/Structural Heart

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]

Cytokinetics Announces Secondary Analysis From GALACTIC-HF to Be Presented in Late Breaking Clinical Trial Session at American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21)

SOUTH SAN FRANCISCO, Calif., March 18, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial […]

PaceMate™ Is Now Listed as a Healthcare Solution in Epic’s App Orchard

BRADENTON, Fla.–(BUSINESS WIRE)–PaceMate™, the leading digital healthcare company in compliant cardiac data management, announced today its recent listing with premier electronic health record company Epic. As part of the App Orchard developer program, PaceMate™’s bidirectional, EHR-integrated application is now available to Epic’s vast network of healthcare customers as a comprehensive, […]

CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., March 16, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to conduct the clinical study, “Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T),” in the United States to support an initial FDA regulatory approval.  This is being done under the previously announced FDA Breakthrough Designation granted for the removal of […]

VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021

28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk Consistent reductions in overall stroke and in ischemic stroke […]

VisCardia Announces Issuance of American Medical Association CPT® Category III Codes for Synchronized Diaphragmatic Stimulation (SDS®)

PORTLAND, Ore., March 16, 2021 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today that the American Medical Association (AMA) has issued (ten) 10 new Current Procedural Terminology (CPT®) Category III codes in support of the implant procedure and management of Synchronized Diaphragmatic Stimulation (SDS®) therapy as provided through VisCardia’s […]

Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm

MINNEAPOLIS, March 16, 2021 /PRNewswire/ — Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis™ algorithm. The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The tool quickly and accurately measures the […]

Apollo Hospitals, India becomes the first Asian Hospital to perform four consecutive MitraClip procedures in a day

CHENNAI, India, March 16, 2021 /PRNewswire/ — The Apollo Hospitals group, one of Asia’s largest and most trusted healthcare group, notched up a record milestone with the successful completion of four consecutive  MitraClip procedures in one day. The MitraClip implants were carried out on four patients suffering from severe heart failure on the same […]

Healthtech Solutions, Inc. (HLTT), Parent Company of Medi-Scan Inc., Announces Incorporation of a New Subsidiary Called RevHeart, Inc.

New subsidiary will further the Company’s research into treating COVID-related heart muscle injury.  A patent has been filed for a therapy to ameliorate and potentially repair myocardial damage. NEW YORK, March 16, 2021 (GLOBE NEWSWIRE) — via InvestorWire — Healthtech Solutions, Inc. (OTC: HLTT) (the “Company”), parent company of Medi-Scan, Inc., today […]

Elixir Medical Announces Commencement of INFINITY-SWEDEHEART Randomized Controlled Trial of DynamX Coronary Bioadaptor System

2,400-Patient Trial Utilizes Globally-Respected SWEDEHEART Registry Database in Randomized Study of First Metallic Device Treating Coronary Artery Disease That Adapts to Vessel Physiology MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced commencement of the INFINITY-SWEDEHEART randomized controlled trial (RCT) of the DynamX™ Coronary Bioadaptor System, the […]