MedTech Dive February 12, 2024
J.P. Morgan analysts noted the agency’s queries on safety but added the document has “simple voting questions” that “all lean towards approval.”
Dive Brief:
- The Food and Drug Administration published a briefing document to inform the discussion at an advisory committee that will debate Abbott’s Triclip device on Tuesday.
- Abbott is seeking premarket approval in symptomatic, severe tricuspid regurgitation on the basis of a pivotal trial that met its primary endpoint but raised questions about the efficacy and safety of the device.
- In a report to investors, J.P. Morgan analysts noted the FDA’s queries on safety, but added the document is “generally supportive” of authorization given the proposed label and “simple voting questions” that “all lean towards approval.”
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