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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 guidelines

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

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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

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.

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.


​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-RQ2524KSMDE-RQ2724KSM​DE-RQ3024KSM​DE-RQ3524KSM​DE-RQ4024KSM
​28 mm​DE-RQ2228KSM​DE-RQ2528KSMDE-RQ2728KSM​DE-RQ3028KSM​DE-RQ3528KSM​DE-RQ4028KSM
​33 mm​DE-RQ2233KSM​DE-RQ2533KSMDE-RQ2733KSM​DE-RQ3033KSM​DE-RQ3533KSMDE-RQ4033KSM​
​38 mm​DE-RQ2238KSM​DE-RQ2538KSMDE-RQ2738KSM​DE-RQ3038KSM​DE-RQ3538KSM​DE-RQ4038KSM

 

 

Ultimaster Clinical Programhttps://www.terumo-europe.com/en-emea/the-comprehensive-clinical-programmeUltimaster Clinical ProgramHayabusaArticlePage
CENTURY II Trialhttps://www.terumo-europe.com/en-emea/clinicaldata/century-iiCENTURY II Trial<ul><li>Multicentre, intercontinental study: 58 sites in 13 countries across Europe, Japan, and South Korea </li><li>Primary endpoint: freedom from TLF at 9 months</li><li>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 </li><li>Clinical follow-up up to 5 years </li><li>Stage: Published and completed<br></li></ul>HayabusaArticlePage
DISCOVERY 1TO3 Trialhttps://www.terumo-europe.com/en-emea/clinicaldata/discovery-1to3-trialDISCOVERY 1TO3 Trial60 MVD patients with OFDI, single arm, primary endpoint TLF @ 12M. PublishedHayabusaArticlePage

 

 

 

 

 

 

Ultimaster™ Tansei™ IFUhttps://www.terumo-europe.com/Relevant Product Info/Ultimaster™ Tansei™ IFU.PDFUltimaster™ Tansei™ IFU15/04/2018 22:00:00{199E72F2-0235-4625-B97B-1F2DB068DC30}HayabusaArticleDocument77054ba1-476b-4af3-b914-9a049e0b9ba8

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.

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