Key result
The MitraClip Delivery System was reviewed by the 2013 FDA Circulatory System Devices Panel to support premarket approval for use in high-risk patients.
Overview of the 2013 FDA panel meeting regarding PMA approval for the MitraClip Delivery System in high-risk patients.
Historical FDA review contextualizes early MitraClip approval pathway in high-risk patients; leaves open questions on updated evidence and indications.
was intended to support PMA approval for using MCS in patients at high risk Overview of the 2013 Food and Drug Administration Circulatory System Devices Panel Meeting on the MitraClip Delivery System
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Minha et al. (2013) studied this question. The MitraClip Delivery System was reviewed by the 2013 FDA Circulatory System Devices Panel to support premarket approval for use in high-risk patients.
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