Abbott has initiated a ABSORB III clinical trial of its drug eluting bioresorbable vascular scaffold (BVS) device, designed for the treatment of coronary artery disease patients.
The Absorb device, which includes a multi-link stent design, is made of a naturally dissolvable polylactide material which gets restored in the vasculature as a normal blood vessel.
The BVS also delivers an anti-proliferative drug, everolimus, which inhibits in-stent neointimal growth in the coronary vessels following stent implantation.
The randomized, controlled trial will enroll 2,250 patients to compare the performance of Absorb device with Abbott's XIENCE family of drug eluting stents.
Target lesion failure, a combined measure of safety and efficacy, at one year is the primary endpoint for the trial.
In addition, a subset of patients within the trial will be evaluated for endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue, according to the company.
The Christ Hospital Heart & Vascular Center and the Lindner Research Center medical director and trial co-primary investigator Dean Kereiakes said, "The deliverability of the Absorb device is impressive and similar to a best-in-class drug eluting stent."
Abbott Vascular chief medical officer and medical affairs divisional vice president Charles Simonton said, "The advancement of Absorb into clinical trials in the United States represents an important step in the process of filing for U.S. regulatory approval - with the goal of establishing Absorb as a new therapeutic option to treat U.S. patients with heart disease, the number one killer of men and women."
