Coronary/Structural Heart

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 […]

First Patients in Canada Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System

Introduction of Orbital Atherectomy in Canada Expands Treatment Options for Patients with Complex Coronary Artery Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patients […]

Nicklaus Children’s Hospital Earns National Recognition For Efforts To Improve Cardiac Arrest Survival In Neonates And Infants

MIAMI, Aug. 31, 2021 /PRNewswire/ — Nicklaus Children’s Hospital has received the American Heart Association’s Get With The Guidelines® – Resuscitation Quality Gold Achievement Award in the neonate and infant category for a second year in a row, due to its commitment to treating in-hospital cardiac arrest, and ultimately helping to improve patient survival […]

Natera Announces the Validation and Launch of the Prospera™ Heart Transplant Assessment Test

Prospera Heart identifies rejection with exceptional performance from a single test, eliminating the need to combine two tests for each patient AUSTIN, Texas, Aug. 31, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in transforming care through genetic and cell-free DNA (cfDNA) testing, today announced the validation and clinical availability of its Prospera Heart […]