Power of N | Terumo India Skill LAb

Overview

Point1The most studied BP-DES, over 50,000 patients world wide

Point2The biggest real world BP-DES registry shows favorable clinical performance

Point3The Longest history BP-DES company

The most studied BP-DES,Over 50,000 patients world wide1-2

Ultimaster has been studied worldwide by enrolling over 50,000 patients in Terumo sponsored tiral and investigator sponsored research. The clinical programs have consistently shown favorable efficacy and safety of Ultimaster even in complex lesions.

TCD-
10023PK
CENTURY CENTURY II MASTER DISCOVERY
1TO3
CENTURY
JSV
e-Ultimaster MASTER
DAPT
COLOR ULISS SCC
registry
SCAAR
Number
of patients
22 105 1123 500 60 70 37,198 4300 388 1,660 1,727 3,253
Design Single arm pharmaco kinetics Single arm,first-in-man study Randomised 1:1 vs Xience Randomised 3:1 vs BMS in patients with STEMI Single arm, patients with multivessel disease Single arm, patients requiring 2.25 mm diameter stents Single arm, all-comers, real-world use Investigator-initiated, randomised, short vs prolonged DAPT Investigator-initiated, randomised complexed large-bore radial PCI trial Single arm, all-commers, multi-center study Single arm, all-commers, single center study Multicenter registry in Sweden
Primary outcomes Sirolimus concentration in peripheral blood samples 28 days after Ultimaster implantation Late loss at 6 months Freedom from TLF at 9 months Safety at 1 month, efficacy at 6 months, safety and efficacy at 12 months OFDI strut coverage at 3 months Freedom from MACE at 9 months TLF at 1 year NACE, MACCE, MCB at 11 months (12 months post-index PCI) BARC bleeding or vascular complication related to access site TLF, TLR and composite endpoint of cardiac death, TV-MI TLR, TLF and MACE ST, Restenosis rate
Stage Published and completed Published and completed Published and completed Published and completed Published and completed Published and completed Completed and accepted for publication Enrolling, protocol published Enrolling Published and completed Published and completed Enrolling
Learn more about our clinical program
Learn more about THE POWER OF BIG
DATA on PCR online

The Biggest real-world BP-DES registry shows favorable clinical performance3

The e-Ultimaster is a single arm, real world registry enrolled over 37,198 patients. Sub-study shows Ultimaster’s favorable performance in the patient group including patients with complex lesions such as bifurcation lesion, LMT, CTO and MVD.

Interim analysis presented at EuroPCR2019

Clinical outcomes at 1 year

Clinical outcomes at 1 year

Learn more about e-Ultimaster

The Longest history BP-DES company4

Terumo launched world’s first biodegradable polymer DES in 2008. Ultimaster is terumo’s secound BP-DES with a thin-strut flexible design contributing to long term patency developed by new biodegradable polymer technology.

Reference

  • 1. Comparison result with Biomatrix(Biosensors), Orsiro(biotronik) and Synergy(Boston scientific) based on information from only press release or product website at April 2020.
  • 2. Total studied patient including Terumo sponsored trials and initiated research at April 2020.
  • 3. M. Roffi, Final results from an all-comer worldwide registry on percutaneous coronary intervention with bioresorbable polymer sirolimus-eluting stent and impact of geographical differences, presented at PCR2020 e-Course
  • 4. Based on CE mark approval date, Nobori was approved on January 16th, 2008.
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