Abbott Medical (Singapore) Pte. Ltd. has sent out a letter addressed to healthcare professionals regarding the worldwide withdrawal and discontinuation of the Trifecta™ line of bioprosthetic heart valves. This action is being taken due to the potential risk of early Structural Valve Deterioration (SVD).
Advise to Healthcare Professionals
Healthcare professionals are to discuss with their patients the potential for early SVD and weigh them against the hemodynamic benefits.
Healthcare professionals are reminded to adhere to the sizing and handling guidelines when implanting a Trifecta valve with Glide Technology (GT) and to conduct regular transthoracic echocardiogram (TTE) studies and observe for any changes in patient’s signs and symptoms to detect deterioration in valve or ventricular function post-implantation.
Patients with evidence of hemodynamically significant SVD should be considered for a possible valve intervention with either surgical aortic valve replacement (SAVR) or a transcatheter valve-in-valve intervention depending on individual patient risks and benefits.
GT: Glide Technology; SAVR: surgical aortic valve replacement; SVD: structural valve deterioration; TTE: transthoracic echocardiogram
FDA: U.S. Food and Drug Administration
Link to the official announcement: https://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/global-retirement-and-discontinuation-of-trifecta-family-of-bioprosthetic-heart-valves-due-to-early-structural-valve-deterioration
Relevant link related to this announcement: https://www.medtechdive.com/news/abbott-pulls-trifecta-heart-valves-deterioration/689515/
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