Abbott has commenced a clinical trial of its drug eluting bioresorbable vascular scaffold (BVS) device, designed to treat patients with coronary artery disease.
Featuring a Multi-Link stent design, the Absorb device is made of a polylactide material that naturally dissolves over time.
The BVS also delivers an anti-proliferative drug, everolimus, which inhibits in-stent neointimal growth in the coronary vessels following stent implantation.
The randomised, controlled trial, named ABSORB III, will enrol 2,250 patients to compare the performance of Absorb with Abbott’s XIENCE family of drug eluting stents.
Target lesion failure at one year, a combined measure of safety and efficacy, is the primary endpoint for the trial.
A subset of patients within the trial will also 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 Centre and the Lindner Research Centre medical director and trial co-primary investigator Dr Dean Kereiakes said; "The deliverability of the Absorb device is impressive and similar to a best-in-class drug eluting stent."
Abbott said it will use the data from the ABSORB III trial to support the US regulatory filings.
Abbott Vascular chief medical officer and medical affairs divisional vice president Dr Charles Simonton said; "The advancement of Absorb into clinical trials in the United States represents an important step in the process of filing for US regulatory approval – with the goal of establishing Absorb as a new therapeutic option to treat US patients with heart disease, the number one killer of men and women."
