About News Contact Careers Europe, Middle East & Africa Terumo Global Products EventsLearning Search HomeMedical fieldInterventional CardiologyUltimaster™ Tansei™ Sirolimus Eluting Coronary Stent System Ultimaster™ Tansei™ Sirolimus Eluting Coronary Stent System Description Characteristics Preparation Clinical evidence General specifications Item specifications Downloads References 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 Clinical evidence MASTER DAPT Study MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus standard DAPT regimen. e-ULTIMASTER Trial One of the largest, prospective worldwide registries 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 Shaft Max 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 2.50 2.75 3.00 3.50 4.00 09 mm DE-RQ2209KSM DE-RQ2509KSM DE-RQ2709KSM DE-RQ3009KSM DE-RQ3509KSM DE-RQ4009KSM 12 mm DE-RQ2212KSM DE-RQ2512KSM DE-RQ2712KSM DE-RQ3012KSM DE-RQ3512KSM DE-RQ4012KSM 15 mm DE-RQ2215KSM DE-RQ2515KSM DE-RQ2715KSM DE-RQ3015KSM DE-RQ3515KSM DE-RQ4015KSM 18 mm DE-RQ2218KSM DE-RQ2518KSM DE-RQ2718KSM DE-RQ3018KSM DE-RQ3518KSM DE-RQ4018KSM 21 mm DE-RQ2221KSM DE-RQ2521KSM DE-RQ2721KSM DE-RQ3021KSM DE-RQ3521KSM DE-RQ4021KSM 24 mm DE-RQ2224KSM DE-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-RQ3533KSM DE-RQ4033KSM 38 mm DE-RQ2238KSM DE-RQ2538KSM DE-RQ2738KSM DE-RQ3038KSM DE-RQ3538KSM DE-RQ4038KSM Enlarge table 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. Do you need more info about this product? Our sales representatives are here for you. 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