Coronary/Structural 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 […]

Sequana Medical announces H1 2021 results and provides business update

alfapump® – Positive results from second interim analysis of POSEIDON pivotal study; awaiting FDA approval on POSEIDON pivotal study expansion alfapump® – FDA regulatory submission now expected in mid-2023 due to worldwide supply shortage of electronic components; European commercial activities and clinical studies unaffected alfapump DSR® – Strong top-line results from RED DESERT; interim results […]

MedAlliance Announces First Patient Enrolled in the 3,300 Patient Landmark Sirolimus DEB vs DES Study

GENEVA, Sept. 1, 2021 /PRNewswire/ — MedAlliance is pleased to announce the enrollment of the first patient in the ground-breaking coronary randomized controlled study “SELUTION DeNovo”. This study utilizes SELUTION SLR™, a novel sirolimus drug-eluting balloon [DEB], versus a limus drug-eluting stent [DES]. This is the largest DEB study ever initiated, with […]

World-first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio® ▼(inclisiran)

Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England1 Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a […]