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Advisers to the U.S. Food and Drug Administration on Tuesday backed an approval for Abbott Laboratories' heart valve repair device that is designed for patients who are at risk of complications or ...
By Puyaan Singh (Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival ...
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug ...
FDA approval for children aged 6–11 was added in January 2021, after a third clinical trial was completed. [33] In 2023, approval was extended to children 2–5. [34] The US Food and Drug Administration (FDA) granted the application priority review, in addition to fast track, breakthrough therapy, and orphan drug designations.
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. [4]
Clinical trial number NCT04625972 for "Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post-exposure Prophylaxis of COVID-19 in Adults (STORM CHASER)" at ClinicalTrials.gov Clinical trial number NCT04625725 for "Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
The FDA has approved Edwards Lifesciences Corp's (NYSE: EW) Mitris Resilia valve, a tissue valve replacement specifically designed for the heart's mitral position. The Mitris Resilia valve has a ...