Edwards’ Pascal Improves Mitral Regurgitation In Early Trial Results
One-month results from the CLASP trial, presented at the German Cardiology Meeting (DGK), show Edwards’ Pascal mitral valve repair device reduces mitral regurgitation in heart failure patients with moderate to severe mitral regurgitation.
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A Delaware court sided with Abbott over Edwards in a pretrial hearing on terminology to be used in a patent dispute concerning transcatheter mitral valve repair device technology.
Edwards Lifesciences is giving up on the Centera transcatheter aortic valve replacement (TAVR), despite promising clinical results, to focus on its Sapien TAVR line. The company reported overall revenue of $1.1bn in the second quarter of 2019, representing 14% year-over-year growth, driven by 18% growth in sales of Sapien systems.
Global Device Approvals Snapshot: 9-15 July 2019; MitraClip G4, Relievion, RAPID Imaging, ExAblate Neuro
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 9-15 July was another slow one for US FDA approvals, with no new PMAs, panel-track PMA supplements, or de novos. Informa’s Meddevicetracker reported three non-US approvals during the week.