It was reported on Tuesday, that the US Food and Drug Administration (USFDA) has approved US-based Abbott's (NYSE:ABT) new trial designed to assess its Amplatzer Amulet Left Atrial Appendage Occluder for people with atrial fibrillation.
The Catalyst trial is reportedly the first-ever clinical trial comparing the effectiveness of a left atrial appendage closure device to a newer class of blood thinners, called non-vitamin K antagonist oral anticoagulant drugs, currently the standard treatment for atrial fibrillation. It will measure the effectiveness of the Abbott Amplatzer Amulet as an alternative treatment option.
Vivek Reddy, MD, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital, and the principal investigator, said, 'A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with atrial fibrillation eligible for long-term NOAC therapy. This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AF who are at an increased risk for ischemic stroke.'
Merck completes acquisition of Verona Pharma to expand cardio-pulmonary portfolio
Amgen offers Repatha through AmgenNow direct-to-patient programme
MedHub-AI's AutocathFFR receives national reimbursement approval in Japan
Early, Evidence-Led Cardiovascular Care Strengthened in High-Risk MENA Regions
Corstasis and U.S. Heart and Vascular partner to advance heart failure care with ENBUMYST
Eli Lilly and Company's orforglipron outperforms oral semaglutide in Phase 3 ACHIEVE-3 trial
Merck reports positive Phase 3 results for oral PCSK9 inhibitor enlicitide
Abbott's Navitor TAVI system granted CE Mark for expanded indication
Cereno Scientific receives FDA Fast Track designation for CS1 in pulmonary arterial hypertension
FDA lifts clinical hold on Rocket Pharmaceuticals' RP-A501 Phase 2 Danon disease trial
OptiBiotix signs distribution deal with major weight management company
Novartis to present cardiovascular abstracts portfolio data at ESC Congress in Madrid
LivaNova announces commercial launch of Essenz Perfusion System in China