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An FDA advisory panel has given unanimous support to a one-of-a-kind dissolving heart stent from Abbott Laboratories
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The FDA advisory committee panel reviewed data from multiple studies of the Absorb dissolving stent, including ABSORB III, a company-sponsored U.S. clinical trial involving approximately 2,000 people that found the investigational device to be comparable to the market-leading metallic drug-eluting stent, Abbott's Xience drug eluting stent. At one year in ABSORB III, patients who received an Absorb dissolving stent had experienced comparable rates of specific adverse events—including heart disease-related death, heart attacks attributed to the stented artery and repeat procedures (collectively termed target lesion failure)—as compared to patients who received the Xience stent.
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Related Keywords Advisory Panel, Fda, Heart Stent, Bioresorbable Drug Eluting Coronary Stent, Absorb Iii, Xience, Target Lesion Failure, Stented Artery, Heart Attack, Heart Disease