Ultimaster Nagomi™ MDR certification and launch of large-scale post-market study investigating the new coronary stent system in complex PCI
First patient enrolled in the NAGOMI COMPLEX PMCF study
With the objective of pursuing product and patient care innovation, Terumo Europe N.V., a leading medical device company, announces the start of a new prospective clinical study: the Ultimaster Nagomi™ sirolimus eluting coronary stent system in complex PCI patients (NAGOMI COMPLEX PMCF study, NCT05705973). The study device, which received CE mark approval in November 2022, is a therapeutically equivalent iteration of Ultimaster™ Tansei™ sirolimus eluting coronary stent system. Ultimaster Nagomi™ inherited the sirolimus-eluting drug, the gradient abluminal bioresorbable coating, as well as the wealth of clinical data from Ultimaster™ stent family1,2,3. It integrates an optimization of the delivery system, an expanded size range and increased overexpansion capability, meeting the need to treat more complex lesions in daily practice.
Coronary heart disease is the most frequently diagnosed heart disease in the world. It is estimated that approximately 200 million people live with coronary heart disease and 9 million people die from it each year.4 Advances in percutaneous coronary intervention (PCI) techniques, such as improvements in imaging equipment, stent design and implantation technique, and post procedure pharmacological therapy, have led to improved patient management and short- and long-term clinical outcomes. Continued product innovation is therefore relevant and will lead to improved clinical outcomes for the patient in the future.
Ihsen Merioua, Chief Medical & Clinical Officer, Terumo Europe, commented: "We are proud to introduce the next iteration of our Ultimaster™ family stents and are thrilled to partner with healthcare providers to bring this new technology to patients. The device can build on the extensive clinical programme of its predecessor, encompassing over 50,000 patients, proving long-term safety and efficacy in various complex patients and lesion subsets. Ultimaster™ family stents are designed for optimal vessel healing and consequently facilitate an abbreviated DAPT regimen as short as 1-month, as previously demonstrated in MASTER DAPT, one of the largest randomized controlled trials on the use of short duration DAPT in high bleeding risk patients after Ultimaster™ implantation. Terumo remains dedicated to building robust clinical evidence generation supporting the new Ultimaster Nagomi™ in complex procedures, enabling patients to benefit from latest innovations."
The NAGOMI COMPLEX PMCF is a large-scale prospective, multicenter, post-market, single-arm observational study. The main objective is to evaluate clinical outcomes in patients treated with the new Ultimaster Nagomi™ stent in complex PCI. Complex patients are defined by specific vessel and lesion characteristics, in whom the PCI procedure is technically more challenging and is associated with a higher risk for ischemic events.
"NAGOMI COMPLEX will collect evidence on the safety and efficacy of the Ultimaster Nagomi™ stent in complex PCI patients," comment the Steering Committee of the study. "These patients represent a considerable segment of the population seen in daily PCI practice. Ultimaster Nagomi™ brings new features and expanded size ranges, making this an excellent treatment option for complex patients. The study plans to enrol 3000 patients, across 60 centers in Europe. In addition to clinical outcomes, the study will specifically focus on collecting health-related quality of life parameters."
Complex PCI will be defined based on specific vessel and lesion characteristics, including multivessel disease, complex bifurcation lesions, left main, CTO, in-stent restenosis, and severe calcification. These patients will be followed up at 30 days, 6 months, 1 year and 2 years post-op. The primary endpoint of this study is target lesion failure defined as cardiovascular death, target-vessel related myocardial infarction and target lesion revascularization at 1 year. This large dataset will allow the investigation of specific patient and lesion subsets.
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), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA.
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 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.
