Coronary/Structural Heart

CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for the U.S. Clinical Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., Sept. 10, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the filing of an Investigational Device Exemption (IDE) application to gain FDA approval to conduct the clinical study, “Safe and Timely Antithrombotic Removal […]

ImpediMed Announces Presentation at Heart Failure Society of America Annual Scientific Meeting That Demonstrates Utility of SOZO® Digital Health Platform for Heart Failure Patients

Study Concludes that HF-Dex™ is a More Sensitive Method Than Weight in Monitoring Fluid Status in Heart Failure Patients CARLSBAD, Calif. and BRISBANE, Australia, Sept. 10, 2021 /PRNewswire/ — ImpediMed Limited (ASX: IPD), a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to improve patient health, today announced a poster presentation […]

CardiAMP Cell Therapy Heart Failure Trial to be Featured in Two Presentations at Heart Failure Society of America Annual Meeting 2021

SAN CARLOS, Calif., Sept. 10, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its CardiAMP® Cell Therapy Heart Failure pivotal trial (ClinicalTrials.gov Identifier: NCT02438306), which are being presented at the Heart […]

scPharmaceuticals Inc. Presents Late-breaking FREEDOM-HF Study Data at the Heart Failure Society of America Annual Scientific Meeting 2021

Data show statistically significant and meaningful reduction in both heart failure-related and overall healthcare costs for patients treated with FUROSCIX® versus a historical comparator group Company on track to resubmit FUROSCIX NDA in the fourth quarter 2021 BURLINGTON, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a […]

Bayer Announces Recipients of the Second Annual Pulmonary Hypertension Accelerated Awards

Seven U.S. researchers working to advance pulmonary hypertension (PH) science and patient care awarded a combined one million dollars in grants Application for the 2021 PHAB Awards is now live for eligible researchers to submit their proposals WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer announced the 2020 recipients of the annual Pulmonary Hypertension Accelerated […]

FDA grants Jardiance® Breakthrough Therapy designation for heart failure with preserved ejection fraction

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 9, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) granted Breakthrough […]

Longeveron Announces Final Results of Phase 1 Clinical Study of Lomecel-B Injection in Hypoplastic Left Heart Syndrome Patients

–Study meets primary safety endpoint: no major adverse cardiac events (MACE), nor any treatment-related infections during the first month post-treatment. –Secondary endpoints measured per protocol suggest Lomecel-B injection may improve patient long-term clinical outcome after surgery: 100% of infants alive and heart-transplant free, with follow-up ranging two to 3.5 years […]

TransMedics Receives FDA Approval for its OCS Heart System Enabling Broader Utilization of Donor Hearts for Transplantation in the U.S.­

ANDOVER, Mass., Sept. 7, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its OCS Heart System for […]

New health economic study proves the value of CADScor® in coronary disease diagnostics

A peer-reviewed publication in the September 2021 edition of PharmacoEconomics shows an estimated 12.3£ million savings to the English health care system per 100,000 eligible patients when using the Acarix CADScor system to rule out coronary artery disease (CAD). Coronary artery disease (CAD) is the most common heart and circulatory […]

HeartFlow Announces Enrollment of First Three Patients in FUSION Trial

National Health Care Institute of the Netherlands-supported study to evaluate role of the HeartFlow Analysis in reducing unnecessary invasive procedures REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced that physicians at Erasmus MC Hospital (Rotterdam NL) have enrolled the first three patients in the […]