Is Your System MR-Conditional?
MR-Conditional Devices
| 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 | ||
| Pacemakers | ACCOLADE™ MRI | L310, L311, L331 | 1.5T or 3T |
| ESSENTIO™ MRI | L110, L111, L131 | ||
| VITALIO™ MRI1 | K275, K277 | 1.5T | |
| S-ICD | EMBLEM™ | A209 | 1.5T |
| EMBLEM™MRI | A219 | ||
| CRT-P | VISIONIST™X4 | U228 | 1.5T or 3T |
| VALITUDE™X4 | U128 | ||
| 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 |
MR-Conditional Leads and Accessories
The following leads and accessories are labeled as MR-Conditional*
• INGEVITYTM MRI: 7735, 7736, 7740, 7741, 7742
• INGEVITYTM MRI: 7731, 7732 (Not valid with ICDs or CRT-Ds)
• INGEVITYTM +: 7840, 7841, 7842
• 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. Not valid with ICDs or CRT-Ds)
• ENDOTAK RELIANCETM 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
• RELIANCETM 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
• ACUITYTM X4: 4671, 4672, 4674, 4675, 4677, 4678
• EASYTRAKTM 2: 4542, 4543, 4544
• ACUITYTM Spiral: 4591, 4592, 4593
• S-ICD ELECTRODES: 3010, 3400, 3401, 3501
• Suture Sleeves: 4603, 6100, 6220, 6221, 6402, 6403, 6773
• Port Plugs: 6996, 7145, 7148
* When conditions of use are met.
1 VITALIO™MRI is only MR-Conditional with INGEVITY™MRI leads.
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.
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