Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.
The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
Boston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular lithotripsy (IVL) system, positioning Boston Sci to challenge Johnson & Johnson’s Shockwave IVL system, which has been the only player in the market.
In the wake of the pandemic, many leading med-tech companies took steps to on-shore and near-shore manufacturing, a move that could protect significant numbers of players from the worst of the effects of the tariffs announced by the Trump administration last week.
Women have substantially greater relative risk of major adverse cardiovascular events associated with a variety of plaque measures assessed by Cleerly Inc.’s AI-enhanced quantitative coronary computed tomography than men, an post hoc analysis of the CONFIRM2 trial found.
Counterintuitively, use of cerebral embolic protection failed to reduce the incidence of stroke in the 72 hours following a transcatheter aortic valve replacement or implantation found a late-breaking clinical trial presented at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in the New England Journal of Medicine.
The two-year results of TRILUMINATE trial showed the first objective benefit to use of Abbott Laboratories’ Triclip transcatheter tricuspid edge-to-edge repair device in a presentation at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in Circulation.
Don’t wait. Edwards Lifesciences Corp.’s additional insights from the Early TAVR trial showed a clear benefit for transcatheter aortic valve replacement (TAVR) in patients with asymptomatic aortic stenosis.
Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.
When every minute matters, quickly determining which patients in the emergency department need urgent care for myocardial infarction can save lives. Researchers at the University Hospital Münster in Münster, Germany, developed a deep learning model that can detect features on electrocardiograms that more accurately identifies which patients require urgent revascularization than clinicians and provides results faster than high-sensitivity troponin lab tests.