TCT 2015: Abbott’s Absorb meets endpoint in U.S. pivotal trial

The Absorb bioabsorbable stent made by Abbott (NYSE:ABT) met its primary endpoint in a U.S. clinical trial that will be used to back a bid for FDA approval, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. One-year data from the Absorb III trial of 2,008 patients showed that the Absorb device was non-inferior to Abbott’s flagship Xience drug-eluting stent. The Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold. The trial showed a rate of target lesion failure of 7.8% for the Absorb arm and 6.1% for the Xience arm and no significant difference in rates of cardiac death (0.6% for the Absorb stent and 0.1% for the Xience stent); target vessel myocardial infarction (6.0% and 4.6%, respectively); or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively. Device thrombosis occurred in 1.5% of Absorb patients and 0.7% of Xience patients, according to the study, which was also published in the New England Journal of Medicine. “The Absorb III data shows that there are no statistically significant 1-year differences between Absorb and Xience, which is a major accomplishment given Xience’s strong performance as the current standard of care,” co-principal investigator Dr. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center said in pr...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Stents Abbott Bioabsorbable Stents Source Type: news