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Overview Product Details Item Specifications Compliance Chart Reference
Ultimaster™ (image)
Stents

Ultimaster™

Sirolimus Eluting Coronary Stent System
  • The most studied BP-DES, with over 50,000 patients worldwide.
  • The biggest real-world BP-DES registry shows favorable clinical performance.
  • The BP-DES with the longest history.
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Reliable Biodegradable polymer-DES
  • The most studied BP-DES, with over 50,000 patients worldwide.
  • The biggest real-world BP-DES registry shows favorable clinical performance.
  • The BP-DES with the longest history.

Long-term efficacy and safety proven by RCT in patients with complex background1,2

 

 
result of CENTURY II trial (image)

Multivessel disease patient1 & True bifurcation lesion2

CENTURY II trial is a prospective, multicenter, randomized(1:1), single-blind, controlled, non-inferiority, and two-arm trial comparing Ultimaster™ and Xience. Complex patient subset results obtained from 5-year follow up shows numerically lower fibrin area/IEL area and inflammation score with significant trend.

 

 

Drug dose of Ultimaster™ (image)

Early healing by abluminal gradient coating and reduced drug dose

  • Ultimaster™ is designed to facilitate endothelialization.
  • Reduced-dose Sirolimus is applied only to the abluminal side of Ultimaster™ to facilitate endothelial coverage while sufficiently maintaining neointimal hyperplasia inhibitory effect.
  • Drug dose reduction minimizes inflammation caused by polymer absorption.
Comparison of gradient coating and conventional circumferential coating (image)
With an animal study comparing abluminal gradient coating and conventional circumferential coating, abluminal gradient coating proved useful. In this study, drug, polymer and stent platform were unified. Coating method was the only difference. Compared with circumferential coating, endothelial coverage was 32% larger for abluminal gradient coating.3

 

Comparison of endothelial coverage (image)
In an animal study comparing Ultimaster™ and Xience/Synergy, Ultimaster™ showed early healing.
Abluminal gradient coating reduces drug/polymer dose and facilitates endothelialization, which were proved by the fibrin area/IEL area and the inflammation score, both of which were lower for Ultimaster™ than those for other biodegradable polymer DES and durable polymer DES.4
In the DISCOVERY 1TO3 trial, Ultimaster™ showed favorable endothelial coverage even 1 month after implantation.5

 

 

radial force of Ultimaster™ (image)

Reliable long-term patency by strong vessel support and fracture resistance

Thinner strut, but higher radial force than recent thin-strut DES.6
Stent under-expansion is one of the risk factors for restenosis and stent thrombosis. Ultimaster™ made of CoCr provides a radial force 1.5 times higher than other recent thin-strut DES.
Uniform 2 link stent design maximize stent flexibility (image)

Flexible platform designed for providing fracture resistance and maintaining natural vessel geometry7

Maintaining natural vessel geometry and providing fracture resistance are essential for a stent to reduce the incidence of stent edge restenosis and maintain stent patency for a long time.
Ultimaster™'s design maximizes its flexibility to decrease fracture risks and maintain natural vessel geometry after implantation. 
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Formulation No./ Model No. Stent diameter (mm) Stent length (mm) Usable catheter length (cm) Distal shaft diameter (Fr.) Distal shaft diameter (mm) Proximal shaft diameter (Fr.) Proximal shaft diameter (mm) Marker Nominal pressure (kPa)
DE-RD4033KSM 4.00 33 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
DE-RD4038KSM 4.00 38 144 2.6 0.88 2.0 0.67 Double 912
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Reference

 

  1. Andrés Iñiguez et al, Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial, Catheter Cardiovasc Interv 2020 Feb;95(2):175-184
  2. Bernard Chevalier, Trea™ent 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
  3. Based on Animal test performed by, and on file at, Terumo Corporation. Result may not necessarily be indicative of clinical performance.
  4. Takeshi Ijichi et al, Comparisons of early vascular reactions in biodegradable and durable polymer-based drug-eluting stents in the porcine coronary artery, PLUS ONE Janualy 10, 2019
  5.  Bernard Chevalier, Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging, Circulation Cardiovascular Interventions, Dec 2017, Vol 10, Issue 12.
  6. Bench test performed by, and on file at, Terumo Corporation. Testing performed on Ultimaster™ Stent System (φ3.0) n=1, CompetitorA (φ3.0) n=1, CompetitorB (φ3.0) n=1. Result may not necessarily be indicative of clinical performance.
  7.  Bench test performed by, and on file at, Terumo Corporation. Testing performed on Ultimaster™ Stent System (φ3.0) n=1(N=3), CompetitorA (φ3.0)  n=1(N=3), CompetitorB (φ3.0)  n=1(N=3). 
    Result may not necessarily be indicative of clinical performance.

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