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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 50mmlength 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
    • Optimized overexpansion capability, up to 6.25 mm (for Ø3.50mm to Ø4.50mm stents)8

  • ​​Excellent Deliverability11

    • New hydrophilic coating for enhanced deliverability10,11
    • New balloon with a nominal pressure of 11 atm for a better apposition7,12
    • Increased catheter inner lumen for fast deflation time13,14

  • ​​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

Video instructions

​  
 


Clinical evidence

TCD-10023PK Trial

20 patients, single arm, pharmocokinetics. Published.

TCD-10023PK Trial

20 patients, single arm, pharmocokinetics. Published.

DISCOVERY 1TO3 Trial

​60 MVD patients with OFDI, single arm, primary endpoint TLF @ 12M. Published

See all clinical evidence

General specifications

Stent specifications
Stent designOpen cell
Stent material
Cobalt Chromium L605
Strut thickness
80 μm
Drug
Sirolimus
Drug dose
3.9 μg/mm stent length
Polymer
Poly (DL-lactide-co-caprolactone)
Drug coatingAbluminal & gradient
Polymer degradation time and drug release
3-4 months



Delivery system specifications
Guidewire compatibility0.014’’ (0.36 mm)
Nominal pressure
11 atm
Rated burst pressure
16 atm
Entry profile
0.018’’ (0.45 mm)
Coating
Hydrophilic – Distal shaft
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 length144 cm



Item specifications


Length (mm) ​Diameter (mm)​ 
2.00 2.25 2.50 2.75 3.00 3.50 4.00 4.50​
9
DE-RS2009ASMDE-RS2209ASM
DE-RS2509ASM
DE-RS2709ASM
DE-RS3009ASM
DE-RS3509ASM
DE-RS4009ASM​DE-RS4509ASM
12
DE-RS2012ASM
DE-RS2212ASM
DE-RS2512ASM
DE-RS2712ASM
DE-RS3012ASM
DE-RS3512ASM
DE-RS4012ASM​DE-RS4512ASM
15
DE-RS2015ASM
DE-RS2215ASM
DE-RS2515ASM
DE-RS2715ASM
DE-RS3015ASM
DE-RS3515ASM
DE-RS4015ASM
​DE-RS4515ASM
18
DE-RS2018ASM
DE-RS2218ASM
DE-RS2518ASM
DE-RS2718ASM
DE-RS3018ASM
DE-RS3518ASM
DE-RS4018ASMDE-RS4518ASM​
21
DE-RS2021ASM
DE-RS2221ASM
DE-RS2521ASM
DE-RS2721ASM
DE-RS3021ASM
DE-RS3521ASM
DE-RS4021ASM
DE-RS4521ASM​
24
DE-RS2024ASM
DE-RS2224ASM
DE-RS2524ASM
DE-RS2724ASM
DE-RS3024ASM
DE-RS3524ASM
DE-RS4024ASM​DE-RS4524ASM
28
DE-RS2028ASM
DE-RS2228ASM
DE-RS2528ASM
DE-RS2728ASM
DE-RS3028ASM
DE-RS3528ASM
DE-RS4028ASM
​DE-RS4528ASM
33
DE-RS2033ASM
DE-RS2233ASM
DE-RS2533ASM
DE-RS2733ASM
DE-RS3033ASM
DE-RS3533ASM
DE-RS4033ASMDE-RS4533ASM​
38
DE-RS2038ASM
DE-RS2238ASM
DE-RS2538ASM
DE-RS2738ASM
DE-RS3038ASM
DE-RS3538ASM
DE-RS4038ASMDE-RS4538ASM​
44
DE-RS2044ASM
DE-RS2244ASM
DE-RS2544ASM
DE-RS2744ASM
DE-RS3044ASM
DE-RS3544ASM
DE-RS4044ASMDE-RS4544ASM​
50
DE-RS2050ASM
DE-RS2250ASM
DE-RS2550ASM
DE-RS2750ASM
DE-RS3050ASM
DE-RS3550ASM
DE-RS4050ASMDE-RS4550ASM
​
​Post-dilation limit
3.50 mm
​4.50 mm
​6.25 mm

Enlarge table

References

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)

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