Features and Types of Ultimaster™ Stent

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Features

Special Topic
Reliable Biodegradable polymer-DES
Designed by TRI pioneer
Bifurcation Excellence

Special Topic

EuroPCR2022 new insight (image)
New insight from MASTER DAPT

MASTER DAPT Complex PCI sub-analysis presented at EuroPCR 2022. You can download it here.

MASTER DAPT summary (image)
MASTER DAPT result

Click here to download a summary of trial primary endpoints.

Reliable Biodegradable polymer-DES
Overview
Point 1
The most studied BP-DES, over 50,000 patients world wide
Point 2
The biggest real world BP-DES registry shows favorable clinical performance

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.

 Number of patientsDesignPrimary outcomesSub Study
MASTER DAPT4300
Investigator-initiated, randomized, short vs standard DAPT
NACE, MACCE, MCB at 11 months (12 months post-index PCI)
Enrolling, protocol published
e-Ultimaster37,198
Single arm, all-comers, real-world use
TLF at 1 yearCompleted and accepted for publication
CENTURY II1123Randomised 1:1 vs XienceFreedom from TLF at 9 monthsPublished and completed
DISCOVERY 1TO360
Single arm, patients with multivessel disease
OFDI strut coverage at 3 monthsPublished and completed
MODEL U-SES1,695Prospective multicenter, single-arm registry, Investigators initiated studyComposite endpoint of all-cause death, MI, stroke, ARC definite / probable stent thrombosis, and BARC 3 or 5 during 12months after stentingPublished and completed
SCAAR3,253Multicenter registry in Sweden
ST, Restenosis rate
Enrolling
SCC registry1,727
Single arm, all-comers, single center study
TLR, TLF, MACE
Published and completed
ULISS1,660
Single arm, all-comers, single center study
TLR, TLF, Composite endpoint of cardiac death, TV-MI
Published and completed
MASTER500Randomized 3:1 vs BMS in patients with STEMI
Safety at 1 month, efficacy at 6 months, safety and efficacy at 12 months
Published and completed
COLOR388
Investigator-initiated, randomized complexed large-bore radial PCI trial
BARC bleeding or vascular complication related to access siteEnrolling
CENTURY105
Single arm, first-in-man study
Late loss at 6 monthsPublished and completed
CENTURY JSV70
Single arm, patients requiring 2.25 mm diameter stents
Freedom from MACE at 9 monthsPublished and completed
TCD-10023PK22

Single arm, pharmaco kinetics

Sirolimus concentration in peripheral blood samples 28 days after Ultimaster implantationPublished and completed

View more about clinical evidence

The biggest real-world BP-DES registry shows favorable clinical performance3

The e-Ultimaster is a single arm, real world registry enrolled over 37,198 patients. Sub-study shows Ultimaster™’s favorable performance in the patient group including patients with complex lesions such as bifurcation lesion, LMT, CTO and MVD.
37198 patients (image)
Final result presented at PCR e-course2020
e-Ultimaster study design (image)
Clinical outcomes at 1 year
Clinical outcomes at 1 year chart (image)

Learn more about e-Ultimaster

The Longest history BP-DES company4

Terumo launched world’s first biodegradable polymer DES in 2008. Ultimaster™ is terumo’s second BP-DES with a thin-strut flexible design contributing to long term patency developed by new biodegradable polymer technology.
The Longest history BP-DES company: Ultimaster (image)

Reference

 

  1. Comparison result with Biomatrix(Biosensors), Orsiro(biotronik) and Synergy(Boston scientific) based on information from only press release or product website at April 2020.
  2. Total studied patient including Terumo sponsored trials and initiated research at April 2020.
  3. M. Roffi, Final results from an all-comer worldwide registry on percutaneous coronary intervention with bioresorbable polymer sirolimus-eluting stent and impact of geographical differences, presented at PCR2020 e-Course
  4. Based on CE mark approval date, Nobori was approved on January 16th, 2008.
Designed by TRI pioneer
Overview
Point 1
Reliable delivery in TRI
Point 2
Product feature
Point 3
Innovative tip
Point 4
Flexible stent design
Point 5
Advance shaft technology with traditional Terumo technology
Reliable delivery in TRI about Ultimaster (image)
Reliable delivery in TRI

Good transmission force even when the guiding catheter does not provide sufficient support1

Ultimaster™ is designed to facilitate delivery for TRI. In TRI, guiding catheter sometime fails to provide sufficient back-up support, leading to guiding catheter disengagement in complex lesion treatment. Ultimaster™ supports not only delivery in challenging cases but also your thought for your patients.

Product feature - Ultimaster (image)
Product feature
Terumo, TRI pioneer has made a contribution to develop of many products designed for TRI. Ultimaster™ is a also device dedicated for TRI which has an innovative tip, flexible stent design and advanced shaft technology with traditional Terumo hydrophilic coating.
Innovative tip - Ultimaster (image)
Innovative tip
Terumo developed an innovative tip dedicated for drug eluting stent delivery. The conventional tip was designed by referring to PTCA balloon catheter. Terumo developed a new tip dedicated for DES from scratch. The newly developed rounded and durable tip minimize the clearance gap between the tip and guide wire.
Flexible stent design - Ultimaster (image)
Flexible stent design
Stent design is simple bioinspired designed with the practical sense of beauty. This stent design allowing maximization of the whole stent from distal edge to proximal edge. The maximized flexibility leads to good trackability especially in stent delivery in complex lesion treatment.

Advance shaft technology with traditional Terumo technology

Ultimaster™ was developed by applying both the advanced technology used for the Terumo PTCA balloon shaft and the traditional hydrophilic coating technology used for the Terumo guidewire. These technologies enhance pushability and trackability under challenging conditions such as TRI where back-up support from a guiding catheter is poor.

Catheter thechnology userd for Terumo PTCA balloon (image)
Hydrophilic coating thechnology used for Terumo Guide wire (image)
Ryurei™ PTCA Balloon movie

Learn more about our product 

Reference

 

  1. Based on Bench test performed by, and on file at, Terumo Corporation. Result may not necessarily be indicative of clinical performance.
Bifurcation Excellence
0% Cardiac Death chart of Ultimaster for Bifurcation excellence (image)
0% Cardiac Death
5 year follow up in Bifurcation sub study1
2.5% TLF chart of Ultimaster for Bifurcation excellence (image)
2.5% TLF
5 year follow up in True bifurcation
Overview
Point 1
Wider over-expansion range
Point 2
Smooth side branch access by the biggest open cell size design
Point 3
Abluminal gradient coating technology ensure polymer integrity

Wider over-expansion range

Wider over-expansion range about Ultimaster (image)
Φ3.0~4.0mm DES is generally used for LMT stenting2. Ultimaster™ has longer total crown length allowing wider over-expansion range.
Over expansion limit
Over expansion limit chart about Ultimaster
Total crown length compared among major drug eluting stent design
Stent design 
forΦ4.0mm		Ultimaster™SynergyXience SierraResolute Onyx
Stent Design
img3.png
img5.png
img7.png
img9.png
Measured total crown length21.5mm19.8mm20.1mm15.2mm

Smooth side branch access by the biggest open cell size design 

Smooth side branch access by the biggest open cell size design about Ultimaster (image)
Side branch access is key parameter for stent selection in treatment of bifurcation lesion.5 Ultimaster™ has the uniform open cell design with the biggest cell size leading to smooth side branch access.
 Total crown length compared among major drug eluting stent design
Stent design 
forΦ4.0mm		Ultimaster™SynergyXience SierraResolute Onyx
Stent Design
img3_0.png
img5_0.png
img8.png
img11.png
Measured total crown length21.5mm19.8mm20.1mm15.2mm
Maximum Cell Diameter6.8mm5.7mm4.8mm6.5mm
Maximum Cell Area36.3mm225.7mm218.1mm233.2mm2

Abluminal gradient coating technology ensuring polymer integrity

Our products are manufactured by paying attention to the details. There is no drug coating on the stent platform at which high stress is concentrated when stent is over-expanded. Ultimaster™ keeps polymer integrity even when the stent is expanded to the maximum diameter.

Polymer integrity at the maximum diameter7
Polymer integrity at the maximum diameter about Ultimaster (image)

PCR e-Course 2020 Industry videos & supported sessions

How to treat complex bifurcation lesions? From bench to being - PCR e-Course 2020

Special Topic

EuroPCR2022 new insight (image)
New insight from MASTER DAPT
MASTER DAPT Complex PCI sub-analysis presented at EuroPCR 2022. You can download it here.
Download new insight

Reference

 

  1. Bernard Chevalier, Treatment of bifurcation lesions with a thin-strut drug eluting stent with bioresorbable polymer long-term clinical outcome of the CENTURY II trial presented at EuroPCR2018
  2. Francesco Burzotta et al, Euro Intervention 2018, Volume 14, 112-120
  3. Instruction for use
  4. Based on Bench test performed by, and on file at, Terumo Corporation (N=1) . Result may not necessarily be indicative of clinical performance.
  5. Jaryl Ng et al, JACC 2016, Volume 221, 171-179
  6. Based on Bench test performed by, and on file at, Terumo Corporation (N=1). Result may not necessarily be indicative of clinical performance.
  7. Based on Bench test performed by, and on file at, Terumo Corporation (N=1). Result may not necessarily be indicative of clinical performance.

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