Abbott Laboratories Says FDA Independent Panel Votes to Approve Heart Device
By Sabela Ojea
Abbott Laboratories said that a Food and Drug Administration panel voted in favor of the safety profile of its heart device TriClip.
The medical device company on Tuesday said that the Circulatory System Devices Panel of the Medical Devices Advisory Committee also confirmed the effectiveness and risk/benefit profile of the device to treat people with tricuspid regurgitation.
Tricuspid regurgitation is a type of heart valve disease that occurs when the tricuspid valve doesn't close tight enough.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
Corrections & Amplifications
This article was corrected at 7:43 p.m. ET to reflect Abbott Laboratories' heart device to treat tricuspid regurgitation is called TriClip. The original version incorrectly called the device Kind TriClip System in the lead paragraph.
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