The Latest Cardiac and Vascular News
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 […]
SANTA ROSA BEACH, Fla., Oct. 20, 2020 (GLOBE NEWSWIRE) — Medical device incubator and technology brokerage firm, Hatch Medical, L.L.C. (www.hatchmedical.com) announced recently that it has entered into an exclusive brokerage relationship with VascuTech Medical and Interventional Radiologist Jonathan Levine, MD for their next generation sheath technology. “Dr. Levine, a […]
PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today announces that it has obtained ANSM (French agency for the safety of […]
Reduction of Patient Complications After Heart Surgery Demonstrated with Use of the ClearFlow’s PleuraFlow ACT System IRVINE, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Irvine, California, has announced positive clinical trial results presented at the 2020 Virtual Program of the Annual Eastern Cardiothoracic Surgical Society Conference (ECTSS) on […]
