ABBOTT PARK, Ill., March 13, 2008 Data published today in The Lancet from ABSORB, the worlds first clinical trial of a fully bioabsorbable drug eluting stent for the treatment of coronary artery disease, demonstrated no stent thrombosis, no clinically driven target lesion revascularizations (re-treatment of a diseased lesion), and a low (3.3 percent) rate of major adverse cardiac events (MACE) in 30 patients out to one year. These one year results for Abbott's bioabsorbable everolimus eluting stent were consistent with performance demonstrated by the system at 6 months, as previously reported in October 2007. Abbott's prospective, non-randomized, ABSORB clinical trial is designed to evaluate the overall safety and performance of a fully bioabsorbable everolimus eluting stent out to 5 years.
"Abbott's bioabsorbable everolimus eluting stent has demonstrated excellent clinical safety out to one year in patients with coronary artery disease," said Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. "The positive results from this clinical trial form a strong basis for the development of additional bioabsorbable stent platforms with the potential to eliminate some of the restrictions posed by metallic stents in areas such as vessel imaging and vessel remodeling."
At 6 months, the overall MACE rate in the ABSORB trial was 3.3 percent (one patient, n=30) and late loss, a measure of reduction in vessel lumen diameter after stenting, was 0.44 mm. At one year, the overall MACE rate in the ABSORB trial was consistent with results at 6 months (one patient, 3.3 percent, n=30; 3.4 percent adjusted for one patient who withdrew from follow-up, known to be event free at 1 year, n=29). MACE is a composite measure of cardiac death, hear
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