Impact of early surveillance on safety signal identification in the CathPCI DELTA study.

Arjun Majithia,Michael E Matheny,Sourbha S Dani,Jessica K Paulus,Danica Marinac-Dabic,Susan Robbins,Henry Ssemaganda,Kathleen Hewitt,Angelo Ponirakis,Nilsa Loyo-Berrios,Issam Moussa,Joseph Drozda,Sharon-Lise Normand,Frederic S Resnic

BMJ surgery, interventions, & health technologies（2020）

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摘要

Prospective, active surveillance of cardiovascular registries is feasible to perform comparative analyses of medical devices. Retrospective data may complement prospective surveillance to improve time to signal detection, indicating the need for earlier prospective application of safety surveillance for devices new to the market.

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关键词

active surveillance,device safety,device surveillance,vascular devices

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