The Latest Cardiac and Vascular News
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
– 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 […]
RED DESERT: Results from first five patients indicaterepeated dose alfapump DSR therapy to be safeandeffective Interim data support DSR hypothesis: kidneys eliminate free water to maintain patients’ serum sodium levels No patients required loop diuretic therapy during the six-week alfapump DSR treatment period Followingalfapump DSR treatment, loop diuretic responsiveness was restored to near normal levels; effect was durable for months post-treatmentwith majority of patients requiring little or no diuretic therapy Full RED DESERT data on track […]
In non-dialysis and dialysis-dependent CKD patients, Major Adverse Cardiovascular Event (MACE) and MACE+ incidence rates were lowest when patients achieved hemoglobin levels ≥ 10 g/dL Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined SAN FRANCISCO, Oct. 22, 2020 […]
