An FDA advisory panel voted 13 to 1 that the benefits of Abbott's first-of-its-kind transcatheter system to treat tricuspid regurgitation outweigh any potential risks.
Receive email when new articles are published onAn advisory committee to the US Food and Drug Administration has voted in favor of Abbott's TriClip transcatheter edge-to-edge repair system for repair of severeThe thumbs up by the Circulatory System Devices Panel of the Medical Devices Advisory Committee was based in large part on data from theConducted at 65 centers in the United States, Canada, and North America, the trial enrolled 350 patients with severe TR who were randomly allocated to...
The study results were presented last year at the joint scientific sessions of the American College of Cardiology/World Congress of Cardiology andAll 14 advisory panel members felt the data were adequate to support the safety of the device.program, at Minneapolis VA Medical Center, Minneapolis, Minnesota, said that "overall, the totality of the evidence is favorable. And it's important to consider what the alternatives are for these patients, and their alternatives are quite limited.
In the trial, at 30 days, 87.0% of the patients in the TEER group had TR no greater than moderate severity vs 4.8% of those in the control group. The incidence of death or tricuspid valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. Paul Hauptman, MD, professor of medicine, University of Nevada, Reno School of Medicine, Reno, Nevada, who voted yes on safety, voted no on this efficacy question. "I just felt the need to pull back a little bit on unbridled enthusiasm because I think we have a responsibility to better understand who is going to benefit and that needs better definition."
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