VERQUVO Approved for Reduction of Risk of Cardiovascular Death and Heart Failure (HF) Hospitalization Following a Hospitalization for HF or Need for Outpatient Intravenous (IV) Diuretics in Adults with Symptomatic Chronic Heart Failure and Ejection Fraction Less than 45% VERQUVO is the First Soluble Guanylate Cyclase Stimulator, Approved to Treat […]
Author: Ken Dropiewski
JACC Study: PEN Indigo Aspiration System Meets Safety/Efficacy Endpoints
A study published online first in the JACC: Cardiovascular Interventions found that Penumbra, Inc.’s Indigo Aspiration System met its predefined safety and efficacy endpoints for the treatment of pulmonary embolism (PE) in the EXTRACT-PE study. Specific results include a significant mean reduction in right ventricular (RV)/left ventricular (LV) ratio of […]
Cardiovascular Systems, Inc. Receives CE Mark for Diamondback 360® Coronary Orbital Atherectomy System
One solution to both reduce surface calcium and fracture deep calcium ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that it has received CE Mark for its Diamondback […]
Verve Therapeutics Secures $94 Million in Series B Financing to Advance Pipeline of Gene Editing Medicines for Cardiovascular Disease
Proceeds Support Advancement of VERVE-101 toward Clinical Initiation in 2022 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Verve Therapeutics, a biotech company pioneering gene editing medicines to treat cardiovascular disease, today announced the successful completion of a $94 million Series B financing, led by Wellington Management Company and co-led by Casdin Capital, existing investors. New […]
Cardialen Awarded $2.8 Million Federal Grant to Advance Therapy Designed to Treat Dangerous Heart Rhythms
National Institutes of Health grant will support Cardialen’s development of its implantable, low-energy therapy designed to treat atrial fibrillation, a cardiac arrhythmia associated with debilitating shortness of breath, fatigue, pain, and an increased risk of stroke. MINNEAPOLIS–(BUSINESS WIRE)–Cardialen, Inc., has been awarded a $2.8 million National Institutes of Health (NIH) […]
Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging
FDA Clears Potential Hurdle for Many Heart Failure Patients MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval […]
Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)
SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire/ — Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) […]
Hillrom Announces Planned Acquisition Of Bardy Diagnostics, Inc.
Hillrom Advances Digital Health Offering With Expansion Into Attractive Ambulatory Cardiac Monitoring Segment CHICAGO, Jan. 19, 2021 /PRNewswire/ — Hillrom (NYSE: HRC) today announced it has reached a definitive agreement to acquire Bardy Diagnostics, Inc. (BardyDx), an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies. Under the terms of […]
DiNAQOR Acquires EHT Technologies GmbH to Advance Engineered Heart Tissue R&D Capabilities
PFÄFFIKON, Switzerland, Jan. 19, 2021 /PRNewswire/ — DiNAQOR, a gene therapy platform company, today announced that it has acquired EHT Technologies GmbH, a Germany-based engineered heart tissue (EHT) technology platform company. Financial terms of the transaction were not disclosed. EHT Technologies was founded in 2015 based upon research on human induced pluripotent stem cells (hiPSC) at […]
2-French Electrophysiology Microcatheter Launches in Europe, Enabling Deeper Coronary Sinus Mapping
TORONTO, Jan. 19, 2021 /PRNewswire/ — Baylis Medical announced today the launch and first clinical case in Europe of the JLL 2-French electrophysiology microcatheter, performed by Dr. Thomas Deneke at Heart Center, Bad Neustadt, Germany. The launch enables physicians to reach previously inaccessible areas of the heart for procedure mapping, by making available the smallest diagnostic catheter in the […]
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