The FDA approved the world's first non-surgical heart valve to treat severe pulmonary valve regurgitation, which often affects individuals with congenital heart disease. Medtronic plc’s Harmony transcatheter pulmonary valve system (TPV) improves blood flow to the lungs without open-heart surgery. The device could extend the time before an individual born with heart disease needs open-heart surgery and the total number of such surgeries they have to endure over their lifetime.
Keeping you up to date on recent developments in cardiology, including: Algorithms can distinguish varying grades of pulmonary edema in heart failure; Cholesterol-independent heart disease risk gene; Study confirms role of smoking in CAD among Blacks.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA approves Harmony device to treat patients with congenital heart disease.
Vetex Medical Ltd.'s Revene thrombectomy catheter reduced symptoms and improved quality of life in all patients with iliofemoral vein thrombus in a European clinical study. The results were presented at Venous 2021, the annual meeting of the American Venous Forum.
The U.S. FDA has granted breakthrough device designation to Tempus Inc. for its ECG Analysis Platform. Developed in collaboration with Geisinger, the artificial intelligence (AI)-powered platform helps clinicians identify patients at increased risk of developing atrial fibrillation (AF) or atrial flutter.
TORONTO – Hemocath Ltd. is gearing up for a first-in-human trial of a device that addresses two critical metrics for the treatment of heart failure: pulmonary artery and central venous pressure. Hemocath’s pulmonary artery catheter (PAC) is part of a larger heart failure monitoring platform and is intended to assess fluid status in patients with severe or worsening congestive heart failure. The hope is to replace larger, more invasive catheters inserted into a patient’s neck.
Keeping you up to date on recent developments in cardiology, including: Translational medicine slow to change cardiovascular care; New study results boost case for BASILICA; Mitral repair still worthwhile despite issues with atrial fibrillation.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation.
Keeping you up to date on recent developments in cardiology, including: Lack of ‘moral compass’ cited as driver of increase in atherectomy in PVI; Study links hypertension to atrial fibrillation; Machine learning of limited value in predicting in-hospital AMI death.
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