Enrolment Complete In ABSORB III Trials
Abbott has completed enrolment in three clinical trials to support approvals of the company's Absorb bioreabsorbable vascular scaffold in the US, Japan and China. Absorb received CE mark approval in 2011 and is available in more than 60 countries worldwide.
Absorb works by opening a blocked vessel and restoring blood flow to the heart similar to a metallic stent; however, unlike a metallic stent, Absorb dissolves over time, potentially leaving behind a more flexible vessel because it is free from a permanent metallic stent that cages the vessel. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant. Absorb is made of polylactide.
The ABSORB III trial, which enrolled approximately 2,000 people in the US, will evaluate the potential benefits of Absorb in people with coronary artery disease. The primary endpoint of ABSORB III is target lesion failure (TLF), a combined measure of the safety and effectiveness of Absorb in comparison with Abbott's Xience range of drug-eluting stents at one year.
The ABSORB Japan and ABSORB China trials enrolled approximately 400 people each, and the primary endpoint is TLF at one year and late loss at one year, respectively, in comparison with the Xience range of drug-eluting stents. ABSORB II enrolled approximately 500 people, mostly in Europe, and one-year clinical results are anticipated later in 2014.
Absorb delivers everolimus, an antiproliferative drug used in Abbott's X ience coronary stent systems.