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Ultimaster™ Family Clinical Program

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Featured products: Ultimaster™ Sirolimus Eluting Coronary Stent System, Ultimaster™ Tansei™ Sirolimus Eluting Coronary Stent System, Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System

9/7/2018 - Global

A comprehensive clinical program

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Assessment of ‘safety’ refers to the side-effect profile and clinical events experienced (eg stroke, myocardial infarction, unplanned revascularisation). BMS, bare-metal stent; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebral events; MACE, major adverse coronary events; MCB, major or clinically relevant non-major bleeding; NACE, net adverse clinical endpoints; OFDI, optical frequency domain imaging; PCI, percutaneous coronary inte​​​​rvention; STEMI, ST-segment elevation myocardial infarction; TLF, target lesion failure. ​​​​​​​


A remarkable 16 CE marked indications



 


Consistent good sa​​fety* data at 1 year from controlled clinical trial4 and routine clinical practice8

 

For CENTURY II, patient numbers are from the per-protocol analysis at baseline. p=non-significant, unless otherwise stated.
MI, mycordial infarction; ST, stent thrombosis; TV, target vessel.

*Statements on 'safety are based on cardiac death, MI and ST rates in the referenced study.


 Sustained long-term sa​fety* from controlled clinical trial4​

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For CENTURY II, patient numbers are from the per-protocol analysis at baseline. p=non-significant, unless otherwise stated.
MI, mycordial infarction; ST, stent thrombosis; TV, target vessel.

*Statements on 'safety are based on cardiac death, MI and ST rates in the referenced study,**data on file.


1-month DAPT for H​​BR patients

​​MASTER DAPT is the largest multi-center randomized controlled study to confirm the safety and efficacy of abbreviated DAP in HBR patients following stenting procedures with Ultimaster Family DES. Learn more.​

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Referenc​​es:​

  1. Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105;
  2. Barbato E et al. EuroIntervention 2015;11:541–8;
  3. Saito S et al. Eur Heart J 2014;35:2021–31;
  4. Wijns W et al. EuroIntervention 2018;14:e343–51;
  5. Valdes-Chavarri M et al. EuroIntervention 2019;14:e1836-42;
  6. Chevalier B et al. Circ Cardiovasc Interv 2017;10:pii:e004801;
  7. Mohamed et al. EuroIntervention 2020;16:603-612
  8. Cimci M et al. Heart 2022;108:1310-1318.
  9. Frigoli E et al. Am Heart J 2019;209:97-105
  10. Valgimigli M et al. N Engl J Med 2021;385:1643-1655
  11. Kozuma K et al. Circ J 2020;85:19-26
  12. Hioki H et al.J Cardiol 2021;78:107-113​​