Other News

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 […]

Getinge launches NICCI – the latest innovation in Advanced Hemodynamic Monitoring

NICCI is Getinge’s latest innovation in Advanced Hemodynamic Monitoring, providing continuous and noninvasive hemodynamic insights to reduce the risk of severe complications for patients with low blood pressure GOTHENBURG, Sweden, Oct. 26, 2020 /PRNewswire/ — Blood pressure is one of the most important variables evaluated during almost every surgical intervention, but recent […]

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease

Application seeks approval of XARELTO® plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD) XARELTO® is currently approved to reduce the risk of major cardiovascular events, like heart attack and stroke, in people with chronic PAD […]

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 […]

Titan Medical Announces Achievement of $10 Million Technical Milestone Under Medtronic Development and License Agreement

TORONTO–(BUSINESS WIRE)–Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announced today that it has completed the first technical milestone under the development and license agreement with Medtronic plc (“Medtronic”) […]

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 […]