Ultimaster Tnasei Sirolimus eluting coronary stent system

OPTIMIZED CATHETER DESIGN FOR STENT DELIVERY

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

Maximizing transmission force,
and kink resistance³

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

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

Building on the heritage of the Ultimaster stent

Ultimaster Tansei has all the key features of Ultimaster for supporting vascular repair⁵

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 match the
procedure-triggered biological response

Ultimaster achieves a remarkable 16 CE approved indications

Recommended DES in ESC/EACTS 2014 guidelines⁸

* 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.

PRODUCT SPECIFICATIONS

Stent specifications

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

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
Shaft Distal - 2.7 Fr (0.89 mm)
Proximal - 1.9 Fr (0.64 mm)
Coating Abluminal & gradient
Minimum Guide catheter 5 Fr (0.056'' /1.42 mm)
Usable length 144 cm

Reference

  • 1. Bench test performed by, and on file at, Terumo Corporation. Testing performed on Ultimaster Tansei Stent System (3.0 x 38 mm) n=3, Resolute Onyx Stent System (3.0 x 38 mm) n=3, Orsiro Stent System (3.0 x 35 mm) n=3, Xience Alpine Stent System (3.0 x 38 mm) n=3, Synergy Stent System (3.0 x 38 mm) n=3.
  • 2. Bench test performed by, and on file at, Terumo Corporation. Testing performed on Ultimaster Tansei Stent System (3.0 x 38 mm) n=3, Resolute Onyx Stent System (3.0 x 38 mm) n=3, Orsiro Stent System (3.0 x 35 mm) n=3, Xience Alpine Stent System (3.0 x 38 mm) n=3, Synergy Stent System (3.0 x 38 mm) n=3.
  • 3. Bench test performed by, and on file at, Terumo Corporation.
  • 4. Bench test performed by, and on file 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 35 mm) n=1, Xience Alpine Stent System (3.0 x 38 mm) n=1, Synergy Stent System (3.0 x 38 mm) n=1.
  • 5. Discovery 1to3: Chevalier B et al. Circ Cardiovasc Interv 2017;10.
  • 6. Data on file at Terumo Europe
  • 7. Ultimaster clinical data for specific indications, Annex to PS-6079, Clinical evaluation report, prepared November 2016; Data on file at Terumo Europe
  • 8. 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.
  • 9. Ultimaster IFU
    Ultimaster Tansei is not available for sale in all countries. Please contact your Terumo local sales representative for more information.