Is Your System MR-Conditional?
Therapy | Device Name | Device Model Numbers | MRI System Configuration* |
---|---|---|---|
ICM | LUX-Dx™ | M301 | 1.5T or 3T |
LUX-Dx II™ | M302 | ||
LUX-Dx II+™ | M312 | ||
S-ICD | EMBLEM™ | A209 | 1.5T |
EMBLEM™MRI | A219 |
S-ICD ELECTRODES: 3010, 3400, 3401, 3501
Brady Pulse Generators
Therapy | Device Name | Device Model Numbers | MRI System Configuration* |
---|---|---|---|
Pacemakers | ACCOLADE™ MRI | L310, L311, L331 | 1.5T or 3T |
ESSENTIO™ MRI | L110, L111, L131 | ||
Proponent™ MRI | L210, L211, L231 | ||
VITALIO™ MRI1 | K275, K277 | 1.5T | |
CRT-P | VISIONIST™X4 | U228 | 1.5T or 3T |
VALITUDE™X4 | U128 |
Right Atrium and Right Ventricle
INGEVITYTM MRI: 7731, 7732, 7735, 7736, 7740, 7741, 7742
INGEVITY+TM: 7840,7841, 7842
Suture Sleeves for INGEVITYTM MRI/INGEVITYTM+ leads: 6402
FINELINETM II: 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480
(Not valid with VITALIO MRI.)
FINELINETM II: 4456, 4457, 4458, 4459 (Not valid with VITALIO MRI.)
Suture Sleeves for FinelineTM leads: 6220, 6221
Port Plugs: 7145
Left Ventricle
ACUITYTM X4: 4671, 4672, 4674, 4675, 4677, 4678
Suture Sleeves: 4603
Port Plugs: 7148
1. VITALIO™MRI is only MR-Conditional with INGEVITY MRI/INGEVITY+ leads only.
Tachy Pulse Generators
Therapy | Device Name | Device Model Numbers | MRI System Configuration* |
---|---|---|---|
ICDs | RESONATE™ HF | D532, D533 | 1.5T or 3T |
RESONATE™ | D432, D433 | ||
VIGILANT™ | D232, D233 | ||
PERCIVA™DF4 | D412, D413 | ||
PERCIVA™DF1 | D400, D401 | 1.5T | |
MOMENTUM™ | D120, D121 | ||
AUTOGEN™ | D160, D161, D162, D163 | ||
DYNAGEN™ | D020, D021, D022, D023, D150, D151, D152, D153 | ||
INOGEN™ | D010, D011, D012, D013, D140, D141, D142, D143 | ||
CRT-Ds | RESONATE™ HF | G547 | 1.5T or 3T |
RESONATE™ | G447 | ||
VIGILANT™ | G247 | ||
VIGILANT™ | G248 | 1.5T | |
MOMENTUM™ | G124, G125, G138 | 1.5T | |
AUTOGEN™ | G160, G161, G166, G168 | ||
DYNAGEN™ | G150, G151, G156, G158 | ||
INOGEN™ | G140, G141, G146, G148 |
Right Atrium
INGEVITYTM MRI: 7735, 7736, 7740, 7741, 7742
INGEVITY+TM: 7840,7841, 7842
Suture Sleeves for INGEVITYTM MRI/INGEVITY+ leads: 6402
FINELINETM II: 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480
Suture Sleeves for Fineline leads: 6220, 6221
Port Plugs: 7145
Right Ventricle
ENDOTAK RELIANCE 4-SITETM (DF4): 0262, 0263, 0265, 0266, 0272, 0273, 0275, 0276, 0282,
0283, 0285, 0286, 0292, 0293, 0295, 0296
ENDOTAK RELIANCETM (DF1): 0127, 0128, 0129, 0137, 0138, 0139, 0143, 0147, 0148, 0149, 0153,
0157, 0158, 0159, 0170, 0171, 0172, 0173,0174, 0175, 0176, 0177, 0180, 0181, 0182, 0183, 0184,
0185, 0186, 0187 (1.5 T only applies to all)
RELIANCE 4-FRONTTM: 0636, 0650, 0651, 0652, 0653, 0654, 0655, 0657, 0658, 0662, 0663,
0665, 0672, 0673, 0675, 0676, 0682, 0683,0685,0686, 0692, 0693, 0695, 0696
Suture Sleeves for RELIANCE 4-FRONTTM: 6403
DF-1 Lead Port Plug for ENDOTAK RELIANCETM (IS-1) Leads- Single Coil: 6996 (1.5 T only)
*When conditions are met.
Left Ventricle
ACUITYTM X4: 4671, 4672, 4674, 4675, 4677, 4678
Suture Sleeves: 4603
IS4/DF4 Port Plugs: 7148
ACUITYTM Spiral: 4591, 4592, 4593 (1.5 T only)
Suture Sleeves for ACUITY Spiral Leads: 6100 (1.5 T only applies to all)
EASYTRAKTM 2: 4542, 4543, 4544 (1.5 T only)
Suture Sleeves for EASYTRAKTM 2 Leads: 6773 (1.5 T only applies to all)
IS-1 Port Plugs: 7145 (1.5 T only)
* When conditions of use are met.
This document contains Boston Scientific CRM devices that are approved by the FDA as MR-Conditional as of August 2019. Visit http://www.bostonscientific.com/imageready for additional information including cardiology/radiology checklists, conditions of use, patient resources, and the MRI Technical Guide.
For a full list of Conditions of Use, and potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide. All items on the full listof Conditions of Use must be met in order for an MRI scan to be considered MRI Conditional.
Indications, Safety and Warnings
CRT-D Systems – RESONATE™HF, RESONATE™, RESONATE™X4, VIGILANT™, VIGILANT™X4, MOMENTUM™, MOMENTUM™ X4
CRT-P Systems – VISIONIST™, VISIONIST™ X4, VALITUDE™, VALITUDE™ X4, INTUA™, INVIVE™
ICD Systems – RESONATE™ HF, RESONATE™ EL, PERCIVA™ HF, PERCIVA™, VIGILANT™ EL, MOMENTUM™ EL
INGEVITY™ MRI Extendable/Retractable Fixation and Tined Fixation
Left Ventricular Pace/Sense Leads– ACUITY X4™
LUX-Dx™ Insertable Cardiac Monitor Systems