Abbott's BVS 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. Absorb is authorized for sale in CE Mark countries. Absorb is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia and New Zealand.
About the Absorb trials
The ABSORB trial is a prospective, single-arm trial that enrolled 131 patients from Europe, Australia and New Zealand in two stages. The first stage started in March 2006 and the second stage in March 2009. Key clinical endpoints of the study include assessments of safety and effectiveness at 30 days, six months and then annually up to five years. The study also will assess the acute performance of the Absorb device (how easily the device can be inserted into the blood vessel). Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive imaging modalities.ABSORB EXTEND is a prospective, single-arm trial that will enroll approximately 800 patients with more complex coronary disease than previously studied in the ABSORB trial, at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The first patient was enrolled in January 2010. Key clinical endpoints of the study include assessments of safety and effectiveness at 30 days, six months and then annually up to three years. Imaging assessments will also be conducted at varying time points up to two years. About Abbott Vascular Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.