Tokyo -- Terumo Corporation (TSE: 4543 Section 1) today announced that Nobori® drug-eluting stent demonstrated positive long-term safety and efficacy at three years in the "NOBORI 2" post-marketing study. The results were presented at the annual EuroPCR 2012 by Dr. Gian Battista Danzi, Ospedale Maggiore, Milan Italy.
The three-year results from NOBORI 2, a 3,067-patient 125-multicenter study in Europe and Asia, demonstrated positive long-term safety and efficacy of Nobori® especially in stent thrombosis,*1 which is generally considered as one of major issues of drug-eluting stent. The annual incidence of stent thrombosis with Nobori® dropped after one year of implantation and stayed low even at three years.
*1 Definite and probable stent thrombosis according to the Academic Research Consortium (ARC) definition
About the NOBORI 2 Post Marketing Study
NOBORI 2 is a prospective, open-label, single-arm, multicenter study that enrolled 3,067 patients with 5,463 lesions in 125 centers in Europe and Asia who were treated with a Nobori®. The enrollment started from April 2008 and completed in March 2009. The primary endpoint of the study is Target Lesion Failure (TLF), a composite of cardiac death, myocardial infarction and target lesion revascularization. The secondary endpoint is stent thrombosis.
About the Nobori Drug-Eluting Stent
The Nobori® drug-eluting stent has a unique design concept with a matrix of biodegradable, polymer polylactic acid (PLA) and the antiproliferative drug Biolimus A9™, coated only abluminally on the highly flexible stent platform. PLA polymer in the Nobori® degrades primarily by hydrolysis, and the degradation product, water-soluble lactic acid, is absorbed by tissue and is eventually converted to water and carbon dioxide. The precise drug release kinetic of the Nobori® matches the biological response to procedure-induced injury with a burst release immediately after stent implantation and continuous drug release along with polymer degradation to further prevent neointima growth.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.