The FDA today warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device made by SentreHeart, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths. The Lariat device is designed to close off the heart’s left atrial appendage, to prevent blood clots […]
SentreHeart wins FDA nod for Lariat trial
SentreHeart said yesterday it won FDA investigational device exemption approval to begin enrolling subjects in a clinical trial of its Lariat device. The Amaze trial will evaluate the use of the Lariat for the ligation of the left atrial appendage as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the company said. “The […]
HRS 2015: SentreHeart’s Lariat device leads to 20% leak rate
A study by researchers from the Texas Cardiac Arrhythmia Institute revealed a 20% rate of atrial leak development after 1 year in patients treated with SentreHeart’s Lariat ligation device.
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