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New Data Demonstrate Clinical Safety and Efficacy of 3-Month DAPT after Ultimaster™ Sirolimus-Eluting Stent Implantation

27/09/2019 - TOKYO, JAPAN

​MODEL U-SES Study Presented at TCT 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 Corporation

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with approximately US$6 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use. Terumo contributes to society by providing valued products and services to the healthcare market, and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.

 

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