TERUMO KOREA CORPORATION

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



	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

	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.

Clinical evidence

e-ULTIMASTER Trial

One of the largest, prospective worldwide registries

Ultimaster™ Family Clinical Program

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
Rated burst pressure	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	Max size - 2.7 Fr (0.89 mm)
Shaft	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
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

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.

⁹Compared 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.