Four Lots of Edwards Mitral Valve Delivery Systems Pulled After Balloon Bursts Linked to One Patient Death - Medical Daily
Edwards withdrew four lots of mitral valve delivery systems after balloon bursts, one linked to a death, and FDA has flagged the system . [NOTABLE] Transcatheter mitral replacement carries no Class I or IIa recommendation in either guideline set.
ESC 2025 grants TMVI only Class IIb for degenerative MS with mitral annular calcification at experienced centres.
Against that, surgical repair for severe primary MR is Class I in both documents, and ESC 2025 upgraded prophylactic repair in asymptomatic patients with preserved LV to Class I when three of four risk markers are present (AF, SPAP >50, LAVI >=60 mL/m2, moderate-or-worse TR).
Four Lots of Edwards Mitral Valve Delivery Systems Pulled After Balloon Bursts Linked to One Patient Death Medical Daily
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