Chronic Ischemic Heart Failure Articles & Analysis
33 news found
DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in ...
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, has named Eric S. Fain, MD as President and Chief Executive Officer effective immediately. The Board of Directors tapped Dr. Fain to build upon the foundation of innovative technology established over recent years and accelerate the progression of product development ...
The code provides clear reimbursement for the study procedure performed for both the treatment and control arms for the ongoing cell therapy pivotal trials in two cardiovascular indications: the CardiAMP Cell Therapy Heart Failure Trial (NCT02438306) and the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (NCT03455725). ...
In fact, we believe that the trial now has the largest enrollment of any trial of intramyocardial bone marrow mononuclear cells performed in ischemic heart failure to date,” said BioCardia CEO Peter Altman, Ph.D. ...
New Phase III study VICTOR will assess vericiguat efficacy and safety in patients who have not had a recent worsening heart failure event / VICTOR expands upon the Phase III VICTORIA study, providing further insight into the use of vericiguat in a broader range of patients with chronic heart failure with reduced ejection fraction Bayer and its development partner MSD (a tradename of Merck & ...
ByBayer AG
Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the mention of their Carillon Mitral Contour System in the 2021 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. In addition, the Carillon Mitral ...
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure. The FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment ...
Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today successful treatment of the first patients in the company’s pilot trial to evaluate the performance of its novel Aortix™ percutaneous mechanical circulatory support (pMCS) device in patients with cardiorenal syndrome (CRS). The company began its ...
Endotronix Endotronix is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable ...
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Professor Pascal Defaye, Head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System. LBBAP pacing has been ...
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment of seasoned medical device industry executive Dan Dearen to its Board of Directors. Mr. Dearen currently serves as the President and Chief Financial Officer of Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology ...
Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain ...
MINNEAPOLIS, Nov. 2, 2020 - CVRx®, developer of the world's first FDA-approved neuromodulation device to treat chronic heart failure (HF), announces that its BAROSTIM NEO™ implantable device has received the Centers for Medicare & Medicaid Services (CMS) inpatient New Technology Add-On Payment (NTAP). Additionally, CMS proposed national coverage determination (NCD) for Breakthrough ...
ByCVRx
Hanover, Germany, October 22, 2020 - Cardior Pharmaceuticals GmbH, a clinical-stage biotech company, focused on the development of noncoding RNA (ncRNA) therapeutics for patients with cardiovascular diseases, today announced a publication in the European Heart Journal (doi:10.1093/eurheartj/ehaa791) demonstrating that repeated treatment with its lead compound CDR132L is safe, improves cardiac ...
MINNEAPOLIS, July 7, 2020 /PRNewswire/ — CVRx, Inc., a private medical device company with a novel technology that treats patients suffering from chronic heart failure (“HF”) and resistant hypertension, announced today that it raised $50 million to close its latest round of equity financing. Proceeds from the financing will be used to support commercialization of the BAROSTIM ...
ByCVRx
Salt Lake City, UT (April 30th, 2020) – Following blind peer review, Second Heart Assist’s clinical data presentation has been selected for oral presentation at the American Society of Artificial Organs (ASAIO) 66th annual conference, scheduled to be held entirely virtual by video June 10th-13th, 2020. The Second Heart Assist abstract will be published in the ASAIO Journal and will ...
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains ...
Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System ...
InGeneron, Inc., a regenerative medicine and cell therapy company, today announced the publication of promising results in developing a novel treatment for chronic ischemic heart failure using its regenerative cell therapy platform. ...
Endotronix Ireland Limited, a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced today an Enterprise Ireland Industry Partnership project in a collaboration with Tyndall National Institute, a leading European Deep Tech research center in integrated ICT (Information and Communications Technology) hardware and software. The 12-month ...