Terumo Europe announces today that it has received MDR approval for an expanded indication of its Ultimaster Nagomi™ and Ultimaster™ Tansei™ sirolimus eluting coronary stent systems.
This new approval covers patients at high bleeding risk, including those eligible for dual antiplatelet therapy (DAPT) as short as one month.
Patients at high risk of bleeding constitute a substantial portion of the population, approximately 45%¹,² of all PCI patients. This approval marks a significant milestone in addressing a major clinical need.
This new indication has been granted thanks to Terumo Europe’s robust clinical data³,⁴,⁵ and the results of the landmark MASTER DAPT study³, reinforcing the safety and performance of the stent systems in this specific patient population.
Prof. Marco Valgimigli, Deputy Chief of Cardiology, Istituto Cardiocentro Ticino, Lugano, CH, commented:
“Ultimaster™ is the only stent with evidence showing that 1-month DAPT is safe and actually safer than a more prolonged regimen in high-bleeding risk patients.”
This achievement underscores Terumo Europe’s commitment to advancing patient care by offering innovative solutions tailored to specific clinical needs. By expanding the indication for high bleeding risk patients, the company continues to support physicians in optimizing treatment strategies while enhancing patient safety.
To learn more about the Ultimaster™ family - A Leading Drug-Eluting Stent for High Bleeding Risk Patients - please visit the website: Ultimaster™ family, one of the best drug eluting stent (DES), to treat your high bleeding risk (HBR) patients²,³,⁴
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For more information
Tristan Langlois
Product Manager Therapeutics – Cardio TIS
tristan.langlois@terumo-europe.com
About Terumo Europe
Terumo Europe N.V. is a core player in the EMEA healthcare market by providing best-in-class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets, and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Hospital Care Solutions, Cardiovascular and Life Care Solutions. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), European Distribution Center in Genk (Belgium) and sales offices across EMEA.
Please visit www.terumo-europe.com for more information.
About Terumo Corporation
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.
DISCLAIMER:
All brand names are trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties. Not all products are available for sale in all countries. This information is provided only in respect to markets where these products are approved or cleared. All products are not cleared or approved in the U.S.A. by the Food and Drug Administration. Please contact your Terumo local sales representative for more information.
References
- Ueki et al. EuroIntervention. 2020 Aug;16(5):371-379. doi: 10.4244/EIJ-D-20-00052.
- NAGOMI COMPLEX study. Results presented at EuroPCR 2024 and EBC 2024.
- Valgimigli et al. N Engl J Med 2021;385:1643-55. DOI: 10.1056/NEJMoa2108749
- Hioki et al. J Cardiol. 2021 Aug;78(2):107-113. doi: 10.1016/j.jjcc.2021.03.015. (MODEL U-SES)
- Godino et al. 2019. Int J Cardiol. 2019 Sep 1;290:52-58. doi: 10.1016/j.ijcard.2019.03.030. (ULISSE registry)