Ultimaster Nagomi

Sirolimus Eluting Coronary Stent System

Description

Navigate the complexities of every procedure for optimal outcomes for/with every patient

You can tackle any procedure with ease, adapting and conforming to the length and contours of vessels. Even in the most challenging anatomy, smooth trackability and reliable overexpansion allow for excellent maneuverability. Ultimaster Nagomi provides the versatility and flexibility you need to deliver the best possible results.1-3

As the newest solution in the Ultimaster product range — now with the largest size line-up — we build on its clinical legacy and expertise, adding a new level of innovation to your practice.1-3

Go anywhere with Ultimaster Nagomi.

Characteristics

Improved Stent Design4,5

  • 3 platforms specifically designed to meet the needs of each vessel size4,5
  • Strut & band width shortened to help increase flexibility (for Ø2.00mm to Ø2.50mm stents)4-6
  • New 10-crown design in the large vessel :
    • to ensure better apposition even in large bifurcations, including left main trunk4,5,7
    • allows a better expansion capability with a uniform vessel coverage compared to an 8-crown design4,5,8,9

Larger Size Line-up11

  • The largest size line-up in the Ultimaster Family, from Φ2.00 to Φ4.50mm and 9 to 50mm length to treat a broader range of lesions4,5,8
  • New 44 & 50m lengths, for optimal sizing in long lesions4,5

Greater Overexpansion Capability11

  • 10-crown design for a better expansion in large vessels4,5,8
  • Optimizedoverexpansion capability, up to 6.25 mm (for Ø3.50mm to Ø4.50mm stents)8

Excellent Deliverability11

  • New hydrophilic coating for enhanced deliverability 10,11
  • New balloon with a nominal pressure of 11 atm for a better apposition7,12
  • Increased catheter inner lumen for fast deflation time 13,14

Inherited Drug and Polymer

  • Inherited abluminal gradient bioresorbable coating to maintain polymer integrity even
  • when overexpanded, allowing for an optimized drug dose of sirolimus (3.9 μg/mm of stent)4,5,15,16, simultaneous polymer resorption and drug release within 3-4 months

Ultimaster Nagomi is building on the Heritage of Strong Clinical Evidence of the Ultimaster Stent Family22

Preparation

Clinical Evidence

General Specifications

Stent specifications

Stent designOpen cell
Stent materialCobalt Chromium L605
Stent thickness80 μm
DrugSirolimus
Drug dose3.9 μg/mm stent length
PolymerPoly (DL-lactide-co-caprolactone)
Drug coatingAbluminal & gradient
Polymer degradation time and drug release3-4 months

Delivery system specifications

Guidewire compatibility 0.014’’ (0.36 mm)
Nominal pressure11atm
Rated burst pressure16 atm
Entry profile0.018’’ (0.45 mm)
CoatingHydrophilic – Distal shaft
Minimum guide catheter Minimum guide catheter
5 Fr for Ø 2.00 – Ø 4.00 mm (0.056’’/1.42 mm)
6 Fr for Ø 4.50 mm (0.071’’/1.80 mm)​
Usable length    144 cm

Item specifications

1. Data on file
2. Wijns W et al. EuroIntervention 2018;14:e343-55
3. Cimci M et al. Heart 2022;doi: 10.1136/heartjnl-2021-320116
4. Technical documentation, PS-0084 
5. Product Standard, PS-1084 
6. Internal test report, LMF-0000041-RAFR-001-1162 
7. Internal test report, LMF-0000041-RAFR-001-1070 
8. Ultimaster Nagomi™ Instructions for Use.
9. Hikichi Y, EBC 2022 (https://youtu.be/hJg2SE4GzPU?t=2967)
10. Internal test report, LMF-0000041-RAFR-001-1202
11. Internal test report, LMF-0000041-RAFR-001-1159
12. Internal test report, LMF-0000041-RAFR-001-1184
13. Internal test report, LMF-0000041-RAFR-001-1044
14. Internal bench test, DC-0109545 
15. Barbato E et al. EuroIntervention 2015;11:541–8
16. Saito N et al. Med Devices 2016;9:33–45
17. PS-6084B
18. Chevalier B et al. Circ Cardiovasc Interv 2017;10:pii:e004801. 
19. Wijns W et al. EuroIntervention 2018;14:e343–51. 
20. Cimci M et al. Heart 2022 108:1310-1318
21. Valgimigli M et al. N Engl J Med 2021;385:1643-1655; 11
22. We have proven equivalency according to the definition in MDR using the guidance on equivalency (MDCG 2020-5)

How can we assist you?

At Terumo Interventional Systems, we don’t just deliver quality medical products – we offer the necessary resources and support to help you use them to their full potential. Contact us today for any assistance you may need.

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