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Ultimaster® - Drug eluting stent

Understanding complexity, for optimal vessel recovery

Pushing the boundaries of science and medical engineering for the improvement of health: Ultimaster combines an optimal balance between stent design for ultimate conformability with simultaneous polymer resorption and drug release, to match the procedure-triggered biological response in the vessel.1 This results in optimal vessel recovery and potentially shortened DAPT time.2

Mastering rapid and healthy coronary vascular repair.

Characteristics

  • ​Drug dose and delivery facilitate early vessel recovery
  • ​Gradient coating reduces risk of polymer cracking and delamination3
  • Ultimaster provides the optimal balance between stent strut coverage, radial force, and visibility

General Specifications

​Stent Specifications

Stent designOpen cell
Stent materialCobalt Chromium L605
Strut thickness80 μm
​Cell size (for 3 mm stent)

​4.57 mm²

DrugSirolimus
Drug dose3.9 μg/mm stent length
PolymerPoly (DL-lactide-co-caprolactone)
CoatingAbluminal & gradient
Polymer degradation time and drug release3-4 months

Procedural Videos

 

Terumo's sponsorship is subject to all necessary regulatory approvals.

Product Illustrations

Drug dose and delivery facilitate early vessel recovery

  • ​Terumo's second-generation bioresorbable polymer coating (PDLLA /PCL) eliminates the long-term polymer exposure1
  •  Targeted abluminal drug delivery allows a reduced drug dose4
    • Half the amount required versus circumferential coating to deliver the same amount of drug to target tissue
    • Luminal side of the stent free from drug and polymer enhances endothelial coverage4

Gradient coating reduces risk of polymer cracking and delamination(3)

​​No drug polymer coating on parts of the stent that experience the most physical stress.5

Ultimaster provides the optimal balance between stent strut coverage, radial force, and visibility

  • ​Thick enough to:
    • Make the stent easy to see, for ease of deployment
    • Maintain radial force across the stent
  •  Thin enough to:
    • Maintain flexibility of the stent
    • Ensure stent coverage

The more complex the task, the more relevant the stent performance

  • Famous Terumo hydrophilic coating on delivery system, stent flexibility and smooth stent-balloon transition enable ultimate stent crossability
  • Low entry profile eliminates the gap between the tip and the guidewire for outstanding trackability

Designed towards facilitating the treatment of the most challenging bifurcations(6)

  • ​Open cell, 2-link design for easy side-branch access
  • Uniform architecture for optimal coverage of bifurcation anatomy
  • Gradient coating ensures polymer integrity reducing risk of delamination, even when overexpanded3

Side branch expansion

Test method: Expand a cell with a balloon at nominal pressure
Cell area: 14.5 mm²

Item Specifications

Length (mm) ​Diameter (mm) ​ ​ ​ ​ ​
2.252.502.753.003.504.00
9DE-RD2209KSMDE-RD2509KSMDE-RD2709KSMDE-RD3009KSMDE-RD3509KSMDE-RD4009KSM
12DE-RD2212KSMDE-RD2512KSMDE-RD2712KSMDE-RD3012KSMDE-RD3512KSMDE-RD4012KSM
15DE-RD2215KSMDE-RD2515KSMDE-RD2715KSMDE-RD3015KSMDE-RD3515KSMDE-RD4015KSM
18DE-RD2218KSMDE-RD2518KSMDE-RD2718KSMDE-RD3018KSMDE-RD3518KSMDE-RD4018KSM
24DE-RD2224KSMDE-RD2524KSMDE-RD2724KSMDE-RD3024KSMDE-RD3524KSMDE-RD4024KSM
28DE-RD2228KSMDE-RD2528KSMDE-RD2728KSMDE-RD3028KSMDE-RD3528KSMDE-RD4028KSM
33DE-RD2233KSMDE-RD2533KSMDE-RD2733KSMDE-RD3033KSMDE-RD3533KSMDE-RD4033KSM
38DE-RD2238KSMDE-RD2538KSMDE-RD2738KSMDE-RD3038KSMDE-RD3538KSMDE-RD4038KSM

 

Recommended DES in ESC/EACTS 2014 guidelines.6

1 month DAPT. CE Mark approved for patients in need.2

 

 

Mastering Rapid and Healthy Vascular Repairhttp://www.terumo-europe.com/en-emea/clinicaldata/mastering-rapid-and-healthy-vascular-repairMastering Rapid and Healthy Vascular RepairPushing the boundaries of science and medical engineering for the improvement of health: Ultimaster combines an optimal balance between stent design for ultimate conformability with simultaneous polymer resorption and drug release, to match the procedure-triggered biological response in the vessel.(1) This results in optimal vessel recovery and potentially shortened DAPT time.(2)HayabusaArticlePage
CENTURY II Trial highlightshttp://www.terumo-europe.com/en-emea/clinicaldata/century-iiCENTURY II Trial highlightsMulticentre, intercontinental study - 58 sites in 13 countries across Europe, Japan, and South Korea - Primary endpoint: Freedom from TLF at 9 months - Secondary endpoint: rate of TVF; patient-oriented composite endpoint; rate of TLR, TVR, ST, cardiac death, MI; composite of cardiac death and MI; rate of bleeding and vascular complications - Clinical follow-up up to 5 years HayabusaArticlePage
DISCOVERY 1TO3 Trialhttp://www.terumo-europe.com/en-emea/clinicaldata/discovery-1to3-trialDISCOVERY 1TO3 Trial60 MVD patients with OFDI, single arm, primary endpoint TLF @ 12M. Ongoing.HayabusaArticlePage

 

 

 

 

 

 

References

1 Data on file at Terumo Corporation (Doc nr. BioRes02-T).
2 Ultimaster IFU. 1 month DAPT CE Mark approved for patients in need. Patients should be maintained on clinically adequate post-procedural antiplatelet therapy according to the current guidelines. In case of need, dual antiplatelet therapy can be discontinued earlier, but not before one month.
3 ​Comparing to DES with uniform coating. Saito N. et al. Drug diffusion and biological responses of arteries using a drug-eluting stent with nonuniform coating. Medical Devices: Evidence and Research 2016:9.
4 Virmani R. CvPath Rabbit Iliac artery. Barbato E. Presented at EuroPCR 2013.
5 Data on file at Terumo Corporation (Doc nr. Grad01-T).
6 Orvin K et al. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheter Cardiovasc Inter v. 2015 Aug 13. doi: 10.1002/ccd.26150.
7 ​Windecker S et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619.

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