Corporate
News release
TopTOKYO, JAPAN - September 27, 2019 - Terumo Corporation (TSE: 4543), a leading global medical device manufacturer, today announced that MODEL U-SES study result was presented at Transcatheter Cardiovascular Therapeutics (TCT) 2019, one of the largest interventional cardiology congresses held in the U.S. This study investigated the safety and efficacy of 3-month dual antiplatelet therapy (DAPT) after Ultimaster™ sirolimus-eluting stent implantation.
After stent implantation, patients are treated with DAPT to prevent thrombus formation inside the stent. However, DAPT increases the risk for major bleeding complications, and it is preferred to shorten the duration of DAPT. The Ultimaster™ Drug-Eluting Stent (DES) is designed with a biodegradable polymer, and the drug and polymer are only applied on the abluminal side of the stent. It is expected that this design may allow DAPT duration to be reduced, due to faster endothelialization of the coronary artery, while preventing neointimal hyperplasia that will cause restenosis.
MODEL U-SES study was designed to evaluate the safety and efficacy of 3-month DAPT after Ultimaster™ implantation. 1,695 patients were enrolled from 65 hospitals in Japan, in this prospective, multicenter, single arm study. The results showed safety and efficacy of Ultimaster™ for 3-month DAPT, compared with a historical control arm (longer DAPT duration in patients treated with Ultimaster™ DES: patient's level propensity matched cohort)
Terumo launched the Ultimaster™ stent in 2014 in EMEA, and 2015 in Japan. The latest model, Ultimaster™ Tansei, is equipped with improved stent delivery system, and is sold in both EMEA and Japan since 2018. As of today, over 1 million of the Ultimaster™ family of DES have been implanted in patients worldwide (excluding the US and China).
Principal Investigator of MODEL U-SES study, Ken Kozuma, MD, PhD, Professor of Cardiology, Teikyo University Hospital commented: "the MODEL U-SES study demonstrated that the patients, those who seems difficult to continue long DAPT, treated with Ultimaster™ DES can shift to single antiplatelet therapy after 3 months of stent implantation with safety and efficacy."
This important study complements the larger (4,300 patients), randomized, MASTER DAPT study that is comparing one-month DAPT versus current guidelines in high bleeding risk (HBR) patients treated with Ultimaster™. The results of the MASTER DAPT study are expected in 2021 and both studies reflect Terumo's commitment to patient's safety and to evidence based clinical practice.
About Terumo
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 30,000 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.