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Ultimaster™ Tansei™

Sirolimus Eluting Coronary Stent System

Description

Mastering Complexity. Simple.​

In clinical practice, where ~80% of cases can be expected to be complex1, it is more important than ever to have tools you can trust for PCI. Ultimaster™ Tansei™ provides enhanced pushability2 and excellent kink resistance2 with a stainless steel tapered core wire at the exit port and advanced shaft technology. With this new DES Terumo introduces a durable yet flexible tip2, specially developed for complex stenting procedures. This innovation will improve the deliverability2 of the whole stent system versus leading stent delivery systems.

Building on the heritage of Ultimaster™ with its proven clinical performance3, Ultimaster™ Tansei™ utilises the same abluminal gradient bioresorbable polymer coating to support early vascular repair4.

Characteristics

  • Building on the heritage of the Ultimaster™ stent

    Ultimaster™ Tansei™ has all the key features of Ultimaster™ for supporting vascular repair1.


    Innovative abluminal bioresorbable coating

    • Drug coating applied in a gradient to reduce the risk of polymer cracking and delamination, even when  the stent is overexpanded
    • PCL added to PDLLA, increasing the elasticity of the bioresorbable polymer coating

    Simultaneous polymer resorption and drug release within 3–4 months, to macth the procedure-triggered biological response

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

  • ​Polymer integrity

    Gradient coating maintains polymer integrity for reduced risk of delamination, even when overexpanded14

  • A tip designed to facilitate treatment of the most challenging cases

    Updated design to maximize deliverability, even in the most challenging cases

    • Flexible tip material: supports navigation through tortuous vessels
    • Low passing resistance at the tip: minimizes the force required to cross challenging lesions

  • A tip specifically developed with the composition and shape to support durability

    • Rounded shape: offers durability and crossability, even through areas of calcification
    • Durable material: reduces the risk of tip damage when navigating challenging anatomy

  • Advanced shaft technology for outstanding acute performance

    Maximizing transmission force, and kink resistance9

    • Shaft reinforced with a stainless steel core wire: ensures optimal pushability and transmission force
    • Stronger hypotube: maximising kink resistance for effective and reliable deliverability

    Ensuring a smooth and balanced transition

    • A stainless steel tapered core wire at the exit port for optimal pushability across the entire delivery system

  • Keep ahead of the curve in complex anatomy

    Enhanced deliverability

    In practice, where ~80% of cases can be expected to be complex1, it is more important than ever to have tools you can trust for percutaneous coronary intervention.

    Ultimaster™ Tansei™ has been developed with challenging cases in mind, achieving optimal trackability and pushability11, which are essential for reliable delivery.


  • ​Combination of key features to optimize its use in complex bifurcation anatomy

    • Open cell, 2-link design eases side branch access – essential for effective bifurcation stenting
    • Uniform scaffolding enables optimal coverage of bifurcation anatomy

  • ​Good overexpansion capacity

    • Post dilatation limit up to 5,5mm12
    • Up to 5.8 mm showed in independent benchtest results13

  • ​Gradient Coating Technology

    No drug coating on parts of the stent that experience the most physical stress

Ultimaster™ Tansei™ has been developed with challenging cases in mind, achieving optimal trackability and pushability, which are essential for reliable delivery. 

Recommended DES in ESC/EACTS 2014 guidelines5 

1-month DAPT* CE marked approved for patients in need to stop DAPT earlier6.

Preparation

Video instructions

 
 


 
 


 
 


 
 


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Clinical evidence

DISCOVERY 1TO3 Trial

​60 MVD patients with OFDI, single arm, primary endpoint TLF @ 12M. Published

MASTER DAPT Study

​​MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus standard DAPT regimen.

MASTER DAPT Study

​​MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus standard DAPT regimen.

See all clinical evidence

General specifications

Delivery system specifications


​Guidewire compatibility​0.014’’ (0.36 mm)
​Low compliant balloon​Material Nylon 12
​Nominal pressure​9 atm
​Rated burst pressure​16 atm - 2.25 to 3.0 mm
​14 atm - 3.5 to 4.0 mm
​Entry profile​0.018’’ (0.45 mm)
​Crossing profile​0.044’’ (1.12 mm) for 3.0 mm
​ShaftMax size - 2.7 Fr (0.89 mm)​
​Min size - 1.9 Fr (0.64 mm)
​Coating​Hydrophilic - Distal shaft
​Minimum Guide catheter​5 Fr (0.056’’/1.42 mm)
​Usable length​144 cm


Stent specifications


​Stent design​Open cell
​Stent material​Cobalt Chromium L605
​Strut thickness​80 μm
​Cell size (for 3 mm stent)​4.57 mm²
​Drug​Sirolimus
​Drug dose​3.9 μg/mm stent length
​Polymer​Poly (DL-lactide-co‑caprolactone)
Coating​Abluminal & gradient
​Polymer degradation time and drug release​3-4 months

Item specifications


​Length (mm)		Diameter (mm)​ ​ ​ ​ ​ ​
2.25​2.502.75​3.00​3.50​4.00​
​09 mm
DE-RQ2209KSM
DE-RQ2509KSM
DE-RQ2709KSM
​DE-RQ3009KSM​DE-RQ3509KSM​DE-RQ4009KSM
​12 mmDE-RQ2212KSM
DE-RQ2512KSM
​DE-RQ2712KSM
​DE-RQ3012KSM​DE-RQ3512KSM​DE-RQ4012KSM
​15 mm​DE-RQ2215KSMDE-RQ2515KSM
​DE-RQ2715KSM
​DE-RQ3015KSMDE-RQ3515KSM​​DE-RQ4015KSM
​18 mm​DE-RQ2218KSM​DE-RQ2518KSM
​DE-RQ2718KSM​DE-RQ3018KSM​DE-RQ3518KSM​DE-RQ4018KSM
​21 mm​DE-RQ2221KSMDE-RQ2521KSM
​DE-RQ2721KSM
​DE-RQ3021KSM​DE-RQ3521KSM​DE-RQ4021KSM
​24 mm​DE-RQ2224KSMDE-RQ2524KSM​DE-RQ2724KSM​DE-RQ3024KSM​DE-RQ3524KSM​DE-RQ4024KSM
​28 mm​DE-RQ2228KSM​DE-RQ2528KSM​DE-RQ2728KSM​DE-RQ3028KSM​DE-RQ3528KSM​DE-RQ4028KSM
​33 mm​DE-RQ2233KSM​DE-RQ2533KSM​DE-RQ2733KSM​DE-RQ3033KSM​DE-RQ3533KSMDE-RQ4033KSM​
​38 mm​DE-RQ2238KSM​DE-RQ2538KSM​DE-RQ2738KSM​DE-RQ3038KSM​DE-RQ3538KSM​DE-RQ4038KSM
Enlarge table

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Downloads

Relevant product information
IFU Ultimaster Tansei

References

Based on data from e-Ultimaster clinical study, data on file Terumo Europe

PCI – Percutaneous Coronary Intervention

1 Internal report ISCD-523-37-19 - Report-eUM-Interim analysis

2 Bench test ISCD-523-31-18 performed by, and on file at Terumo Corporation

3 ULTIMASTER Clinical Program

4 Chevalier et al. Circ Cardiovasc Interv 2017;10:doi:10.1161/CIRCINTERVENTIONS.116.004801

* 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.

5 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. 

6 Ultimaster IFU. 

7 Bench test ISCD-523-31-18 performed by, and on fi le at, Terumo Corporation. Testing performed on Ultimaster™ Tansei™ Stent System (3.0 x38mm) n=3, Resolute Onyx™ Stent System (3.0 x 38 mm) n=3, Orsiro™ Stent System (3.0 x 35mm) n=3, Xience Alpine™ Stent System (3.0 x38mm) n=3, Synergy™ Stent System (3.0x38mm) n=3. 

8 Bench test ISCD-523-31-18 performed by, and on fi le at, Terumo Corporation. Testing performed on Ultimaster™ Tansei™ Stent System (3.0 x 38 mm) n=1, Resolute Onyx™ Stent System (3.0 x 38 mm) n=1, Orsiro™ Stent System (3.0 x 35mm) n=1, Xience Alpine™ Stent System (3.0 x 38 mm) n=1, Synergy™ Stent System (3.0x38mm) n=1. 

9 Compared with Ultimaster. Bench test ISCD-523-31-18 performed by, and on fi le at, Terumo Corporation. 

10 Bench test ISCD-523-31-18 performed by, and on fi le at, Terumo Corporation. Testing performed on Ultimaster™ Tansei™ Stent System (3.0 x 38mm) n=3, Resolute Onyx™ Stent System (3.0 x 38 mm) n=3, Orsiro™ Stent System (3.0 x 35mm) n=3, Xience Alpine™ Stent System (3.0 x 38mm) n=3, Synergy™ Stent System (3.0 x 38mm) n=3. 

11 Bench test ISCD-523-31-18 performed by, and on fi le at, Terumo Corporation. Testing performed on Ultimaster™ Tansei™ Stent System (3.0 x38mm) n=3, Resolute Onyx™ Stent System (3.0 x 38mm) n=3, Orsiro™ Stent System (3.0 x 35mm) n=3, Xience Alpine™ Stent System (3.0 x 38mm) n=3, Synergy™ Stent System (3.0 x 38 mm) n=3.

12CE approval was received on August 2nd, 2019. The IFU will be updated to reflect the specified post dilatation limits.  

13Ng J et al. Int J Cardiol 2016;221:171–9

14Saito N et al. Medical Devices: Evidence and Research 2016:9;33-43.

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