TERUMO INTERVENTIONAL SYSTEMS

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Ultimaster™
Ultimaster™ Tansei™
North America
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APAC
EMEA
Ultimaster ™ Sirolimus Eluting Coronary Stent System

THE POWER OF n

The UltimasterTM Clinical Program

The UltimasterTM Clinical Program included more than 50,000 patients covering 16 CE marked indications.1-3

Complex PCI: n=10,241
patients

Demonstrates favorable outcomes in both complex and non-complex PCI patients.

Bifurcation : n=4,395
patients

Demonstrates proximal optimization technique (POT) is associated with improved outcomes.

MVD : n=15,441
patients

Suggests that complete revascularization is associated with better outcomes versus incomplete revascularization.

Abbreviated DAPT. Groundbreaking results

MASTER DAPT is the largest, multi-center randomized controlled study on the use of abbreviated dual antiplatelet therapy (DAPT) in high bleeding risk patients.

A total cohort of 4,579 patients have been randomized into this ambitious study, designed to prove the efficacy and safety of UltimasterTM and UltimasterTM TanseiTM stents in a short DAPT strategy.

The results are groundbreaking. The MASTER DAPT study shows short DAPT to be noninferior to standard therapy of at least two months, with regard to net and major adverse clinical events. It also shows short DAPT to be superior to standard DAPT for major or clinically relevant non-major bleeding.4

Visit study

Data driving your clinical decisions

The UltimasterTM  Clinical Program included one of the largest, prospective worldwide registries, the e-ULTIMASTERTM with 37,198 patients.5 The UltimasterTM Clinical Program2  demonstrates the safe and effective use of the Ultimaster stent in different patient cohorts, representative of daily PCI practice. 

Total Population
・37,178 patients enrolled in the e-ULTIMASTERTM registry, one of the largest, prospective worldwide registries.
・e-ULTIMASTERTM – a truly all comer’s DES clinical registry.
Complex PCI
・e-ULTIMASTERTM all-comer registry enrolled more than 10,000 patients meeting complex PCI criteria.
・Complex PCI was defined as:
 - Multivessel PCI 3 stents implanted > 3 lesions treated.
 - Bifurcation PCI with > 2 stents, total stent length > 60mm and chronic total occlusion.
Bifurcation
・4,395 patients with bifurcation lesions treated with UltimasterTM DES showed excellent clinical outcomes with TLF of 5.1% at 1 year.
・Use of the proximal optimization technique (POT) was associated with a better clinical outcome with respect to TLF and TVF at 1 year. This was due to a strong impact on the risk of TV-MI, stent thrombosis and revascularization.
Multivessel Disease
・The revascularization strategy (complete versus incomplete revascularization) in multivessel disease patients treated with UltimasterTM DES was assessed at 1-year follow-up.
・Complete revascularization was associated with better relief from angina, lower mortality, less target vessel failure (TVF), and lower patient oriented composite endpoint (POCE).
・UltimasterTM DES demonstrated excellent results in this complex population.

The most studied BP-DES,Over 50,000 patients world wide1-2

Ultimaster has been studied worldwide by enrolling over 50,000 patients in Terumo sponsored trial and investigator sponsored research. The clinical programs have consistently shown favorable efficacy and safety of Ultimaster even in complex lesions.

TCD-
10023PK
CENTURY CENTURY II MASTER DISCOVERY
1TO3
CENTURY
JSV
e-Ultimaster MASTER
DAPT
COLOR ULISS SCC
registry
SCAAR MODEL
U-SES
Number
of patients
22 105 1123 500 60 70 37,198 4300 388 1,660 1,727 3,253 1,695
Design Single arm pharmaco kinetics Single arm,first-in-man study Randomised 1:1 vs Xience Randomised 3:1 vs BMS in patients with STEMI Single arm, patients with multivessel disease Single arm, patients requiring 2.25 mm diameter stents Single arm, all-comers, real-world use Investigator-initiated, randomised, short vs standard DAPT Investigator-initiated, randomised complexed large-bore radial PCI trial Single arm, all-comers, multi-center study Single arm, all-comers, single center study Multicenter registry in Sweden Prospective multicenter single-arm registry, Investigators initiated study
Primary outcomes Sirolimus concentration in peripheral blood samples 28 days after Ultimaster implantation Late loss at 6 months Freedom from TLF at 9 months Safety at 1 month, efficacy at 6 months, safety and efficacy at 12 months OFDI strut coverage at 3 months Freedom from MACE at 9 months TLF at 1 year NACE, MACCE, MCB at 11 months (12 months post-index PCI) BARC bleeding or vascular complication related to access site TLF, TLR and composite endpoint of cardiac death, TV-MI TLR, TLF and MACE ST, Restenosis rate Composite endpoint of all-cause death, MI, stroke, ARC definite / probable stent thrombosis, and BARC 3 or 5 during 12months after stenting
Sub Study Bifurcation Multivessel disease Bifurcation Left Main OAC

A video summary on the Power of n.

Three experts guide you to understand the power of BIG data and how large registry data can impact your practice.

Ultimaster Tansei

Building on the heritage of the original Ultimaster stent, the updated design of the Ultimaster Tansei brings you enhanced pushability and excellent kink resistance to maximize deliverability. Find out how the Ultimaster Tansei can help you master complexity with confidence.

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Ultimaster

Terumo’s proprietary bioresorbable polymer coating and two-link design help facilitate smoother access. Discover how the Ultimaster stent can ensure optimal deliverability and potentially shortened DAPT time.

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Reference

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