Abbott has announced that it has completed enrolment of three clinical trials to support approvals of its Absorb bioresorbable vascular scaffold in the United States, Japan and China. The product, which dissolves over time, will be compared with drug-eluting stents.
The ABSORB III clinical trial, which has enrolled approximately 2,000 people in the United States, will evaluate the potential benefits of Absorb in people with coronary artery disease. Absorb works by opening a blocked vessel and restoring blood flow to the heart in a similar way to a metallic stent, but unlike a metallic stent, it dissolves over time. The primary endpoint of ABSORB III is target lesion failure, a combined measure of the safety and effectiveness of Absorb in comparison to the company’s XIENCE family of drug-eluting stents at one year.
“The rapid completion of enrolment in the Absorb randomised trials is a testament to the interest among doctors and patients in advancing new options to treat heart disease,” says Gregg Stone, director of cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital. “Absorb represents an entirely new approach to helping people with heart disease by doing the job of a metallic stent, but then disappearing after its work is done, giving people the opportunity to live their lives free of a permanent metallic device implanted in their arteries.”
The ABSORB Japan and ABSORB China trials have enrolled approximately 400 people each, and the primary endpoint is target lesion failure at one year and late loss at one year, respectively, in comparison to the XIENCE family of drug-eluting stents. The ABSORB II trial enrolled approximately 500 people, mostly in Europe, and one-year clinical results are anticipated later this year.
The bioresorbable vascular scaffold delivers everolimus, an anti-proliferative drug used in Abbott’s XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug-eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.
Absorb is an investigational device, limited by United States law to investigational use and is not approved or available for sale in the United States. It is authorised for sale in CE mark countries and is available in Europe, the Middle East, parts of Latin America, and parts of Asia, including India.