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Ultimaster® - Drug eluting stent
Understanding complexity, for optimal vessel recovery
Pushing the boundaries of science and medical engineering for the improvement of health: Ultimaster combines an optimal balance between stent design for ultimate conformability with simultaneous polymer resorption and drug release, to match the procedure-triggered biological response in the vessel.1 This results in optimal vessel recovery and potentially shortened DAPT time.2
Characteristics Drug dose and delivery facilitate early vessel recovery Gradient coating reduces risk of polymer cracking and delamination3 Ultimaster provides the optimal balance between intimal stent coverage, radial force, and visibility.
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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
Drug dose and delivery facilitate early vessel recovery
Terumo's second-generation bioresorbable polymer coating (PDLLA /PCL) eliminates the long-term polymer exposure1 Targeted abluminal drug delivery allows a reduced drug dose4 Half the amount required versus circumferential coating to deliver the same amount of drug to target tissue Luminal side of the stent free from drug and polymer enhances endothelial coverage4
Gradient coating reduces risk of polymer cracking and delamination(3)
No drug polymer coating on parts of the stent that experience the most physical stress.5
Ultimaster provides the optimal balance between stent strut coverage, radial force, and visibility
Thick enough to: Make the stent easy to see, for ease of deployment Maintain radial force across the stent Thin enough to: Maintain flexibility of the stent Ensure stent coverage
The more complex the task, the more relevant the stent performance
Famous Terumo hydrophilic coating on delivery system, stent flexibility and smooth stent-balloon transition enable ultimate stent crossability Low entry profile eliminates the gap between the tip and the guidewire for outstanding trackability
Designed towards facilitating the treatment of the most challenging bifurcations(6)
Side branch expansion Test method: Expand a cell with a balloon at nominal pressure
2.25 2.50 2.75 3.00 3.50 4.00 9 DE-RD2209KSM DE-RD2509KSM DE-RD2709KSM DE-RD3009KSM DE-RD3509KSM DE-RD4009KSM 12 DE-RD2212KSM DE-RD2512KSM DE-RD2712KSM DE-RD3012KSM DE-RD3512KSM DE-RD4012KSM 15 DE-RD2215KSM DE-RD2515KSM DE-RD2715KSM DE-RD3015KSM DE-RD3515KSM DE-RD4015KSM 18 DE-RD2218KSM DE-RD2518KSM DE-RD2718KSM DE-RD3018KSM DE-RD3518KSM DE-RD4018KSM 24 DE-RD2224KSM DE-RD2524KSM DE-RD2724KSM DE-RD3024KSM DE-RD3524KSM DE-RD4024KSM 28 DE-RD2228KSM DE-RD2528KSM DE-RD2728KSM DE-RD3028KSM DE-RD3528KSM DE-RD4028KSM 33 DE-RD2233KSM DE-RD2533KSM DE-RD2733KSM DE-RD3033KSM DE-RD3533KSM DE-RD4033KSM 38 DE-RD2238KSM DE-RD2538KSM DE-RD2738KSM DE-RD3038KSM DE-RD3538KSM DE-RD4038KSM
Recommended DES in ESC/EACTS 2014 guidelines.6
1 month DAPT. CE Mark approved for patients in need.2
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Ultimaster Clinical Program https://www.terumo-europe.com/en-emea/clinicaldata/the-comprehensive-clinical-programme Ultimaster Clinical Program HayabusaArticlePage CENTURY II Trial https://www.terumo-europe.com/en-emea/clinicaldata/century-ii CENTURY 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 Trial https://www.terumo-europe.com/en-emea/clinicaldata/discovery-1to3-trial DISCOVERY 1TO3 Trial 60 MVD patients with OFDI, single arm, primary endpoint TLF @ 12M. Published HayabusaArticlePage
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1 Data on file at Terumo Corporation (Doc nr. BioRes02-T).2 Ultimaster IFU. 1 month DAPT CE Mark approved for patients in need. 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.3 Comparing to DES with uniform coating. Saito N. et al. Drug diffusion and biological responses of arteries using a drug-eluting stent with nonuniform coating. Medical Devices: Evidence and Research 2016:9.4 Virmani R. CvPath Rabbit Iliac artery. Barbato E. Presented at EuroPCR 2013.5 Data on file at Terumo Corporation (Doc nr. Grad01-T).6 Orvin K et al. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial. Catheter Cardiovasc Inter v. 2015 Aug 13. doi: 10.1002/ccd.26150.7 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.
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