alfapump® – Positive results from second interim analysis of POSEIDON pivotal study; awaiting FDA approval on POSEIDON pivotal study expansion alfapump® – FDA regulatory submission now expected in mid-2023 due to worldwide supply shortage of electronic components; European commercial activities and clinical studies unaffected alfapump DSR® – Strong top-line results from RED DESERT; interim results […]
Coronary/Structural Heart
MedAlliance Announces First Patient Enrolled in the 3,300 Patient Landmark Sirolimus DEB vs DES Study
GENEVA, Sept. 1, 2021 /PRNewswire/ — MedAlliance is pleased to announce the enrollment of the first patient in the ground-breaking coronary randomized controlled study “SELUTION DeNovo”. This study utilizes SELUTION SLR™, a novel sirolimus drug-eluting balloon [DEB], versus a limus drug-eluting stent [DES]. This is the largest DEB study ever initiated, with […]
World-first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio® ▼(inclisiran)
Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England1 Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a […]
First Patients in Canada Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System
Introduction of Orbital Atherectomy in Canada Expands Treatment Options for Patients with Complex Coronary Artery Disease 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 the first patients […]
Nicklaus Children’s Hospital Earns National Recognition For Efforts To Improve Cardiac Arrest Survival In Neonates And Infants
MIAMI, Aug. 31, 2021 /PRNewswire/ — Nicklaus Children’s Hospital has received the American Heart Association’s Get With The Guidelines® – Resuscitation Quality Gold Achievement Award in the neonate and infant category for a second year in a row, due to its commitment to treating in-hospital cardiac arrest, and ultimately helping to improve patient survival […]
Natera Announces the Validation and Launch of the Prospera™ Heart Transplant Assessment Test
Prospera Heart identifies rejection with exceptional performance from a single test, eliminating the need to combine two tests for each patient AUSTIN, Texas, Aug. 31, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in transforming care through genetic and cell-free DNA (cfDNA) testing, today announced the validation and clinical availability of its Prospera Heart […]
Amarin Reports Overview of Latest Clinical Research Evaluating VASCEPA®/VAZKEPA (Icosapent Ethyl) and Eicosapentaenoic Acid (EPA) Presented at ESC Congress 2021, Organized by the European Society of Cardiology
VASCEPA/VAZKEPA found in prespecified and post hoc analyses to reduce first and total primary endpoints by 26% and 35%, respectively, in REDUCE-IT patients with prior Myocardial Infarction 2021 ESC Guidelines on Cardiovascular Disease Prevention now include VAZKEPA in their recommendations, marking 20th inclusion in global medical societies’ guidelines DUBLIN, Ireland […]
Cytokinetics Announces Results From REDWOOD-HCM and GALACTIC-HF to Be Presented in Late Breaking Clinical Trials Session at the HFSA Annual Scientific Meeting
Full Results from REDWOOD-HCM Expand on Positive Topline Results of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy Additional Results from GALACTIC-HF Assess the Effect of Omecamtiv Mecarbil in Black Patients with Heart Failure with Reduced Ejection Fraction SOUTH SAN FRANCISCO, Calif., Aug. 31, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today […]
Hello Heart Achieves HITRUST CSF® Certification
Hello Heart is committed to meeting rigorous data privacy and security standards. MENLO PARK, Calif.–(BUSINESS WIRE)–Hello Heart, the leader in cardiovascular digital therapeutics, today announced that the company’s application, data storage, and supporting infrastructure has earned Certified status for information security by HITRUST. HITRUST CSF Certified status demonstrates that the […]
Vifor Pharma’s Ferinject® granted new recommendations in updated 2021 ESC heart failure guidelines
2021 European Society of Cardiology (ESC) guidelines for acute and chronic heart failure (HF) includes new recommendations on management of iron deficiency with Ferinject® (ferric carboxymaltose) in patients with HF Periodic screening for iron deficiency and the use of Ferinject® to reduce hospitalisation rates and improve HF symptoms are now recommended In addition, […]