Coronary/Structural Heart

VALBIOTIS Presents the First Market Data on Untreated LDL-hypercholesterolemia For TOTUM-070, And Announces the Initiation of The Phase II Clinical Study HEART

TOTUM-070 is being developed particularly for individuals with untreated hypercholesterolemia, with LDL-cholesterol levels up to 190 mg/dL associated with moderate overall cardiovascular risk. It responds to an unmet medical need for this population; TOTUM-070 has high potential in the market for non-drug LDL-cholesterol products, which is estimated at 1.2 billion […]

Vascular Care of Texas’ Case Report Published in Vascular Disease Management Showcases Vivify Health’s Remote Patient Monitoring Capabilities

PLANO, Texas, Oct. 27, 2020 /PRNewswire/ — Vivify Health, the developer of the nation’s leading connected care platform for remote patient care, has achieved a new milestone. The use of its remote patient monitoring (RPM) platform to manage care for Vascular Care of Texas’ patients during the COVID-19 pandemic is being highlighted in the October […]

Foldax Receives FDA Approval to Expand Clinical Study of Novel Biopolymer Aortic Heart Valve

SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria™ surgical aortic heart valve. This next stage of enrollment is expected to begin within the next month. “We are excited to expand enrollment […]

Published Peer-reviewed Initial Data from BioCardia Pivotal Phase 3 Clinical Trial of CardiAMP Demonstrates Improvement in Heart Failure Patients Measured by Exercise Outcomes and Cardiac Function

Paper Published in International Journal of Cardiology Demonstrates Safety and Tolerability While Showing Functional Improvement at Six Months SAN CARLOS, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA](“BioCardia” or the “Company”), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the publication of data from the Company’s initial open-label roll-in cohort that served as the […]

VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Cardiovascular Events in Patients with Compromised Renal Function at Baseline in Prespecified and Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at American Society of Nephrology (ASN) Kidney Week 2020

Patients with decreased renal function prior to treatment with VASCEPA or placebo had higher rates of cardiovascular events than the overall population studied in REDUCE-IT REDUCE-IT patients with decreased renal function prior to treatment showed similarly favorable relative risk reductions and numerically greater absolute risk reductions in cardiovascular events in […]

FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™. The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance […]

PhaseBio Provides Pemziviptadil (PB1046) Program Update

VANGARD trial discontinued due to evolving COVID-19 treatment landscape, recent feedback from FDA regarding regulatory and development path, and interim analysis of trial data Enrollment expected to resume for ongoing Phase 2b trial of pemziviptadil in pulmonary arterial hypertension (PAH) MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a […]

Bayer’s FIDELIO-DKD Phase III Study Demonstrated Investigational Drug Finerenone Significantly Reduced Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Finerenone is a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that works on the pathway of MR overactivation, a key contributor to disease progression in patients with chronic kidney disease and type 2 diabetes FIDELIO-DKD is the first large contemporary positive outcomes study in patients with chronic kidney […]

FARXIGA DAPA-CKD Phase III Trial Reduced Worsening of Kidney Function, Risk of Cardiovascular or Renal Death in Patients With Chronic Kidney Disease Irrespective of Underlying Cause

Results reinforce FARXIGA’s potential to treat a wide range of patients with chronic kidney disease WILMINGTON, Del.–(BUSINESS WIRE)–A new subgroup analysis from the ground-breaking DAPA-CKD Phase III trial showed that AstraZeneca’s FARXIGA® (dapagliflozin), on top of standard of care, reduced the composite of worsening of kidney function or risk of cardiovascular […]

New Jardiance® findings showed improved cardio-renal outcomes in adults with heart failure with reduced ejection fraction regardless of chronic kidney disease status

– Jardiance (empagliflozin) reduced risk for the composite endpoint of cardiovascular death and hospitalization for heart failure, as well as serious adverse kidney outcomes, in adults with or without chronic kidney disease at baseline. The trial included people with and without diabetes – Sub-analysis findings from the EMPEROR-Reduced phase III […]