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The Amplia MRI™ CRT-D SureScan™ Model DTMB1D4/DTMB1D1 and Amplia MRI Quad CRT-D SureScan Model DTMB1QQ/DTMB1Q1, hereafter referred to collectively as the Amplia MRI CRT-D device, is MR Conditional and, as such is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MRI conditions for use. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing.
INDICATIONS FOR USE
The Amplia MRI CRT-D system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following classifications: New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection fraction ≤ ۳۵% and a prolonged QRS duration. Left bundle branch block (LBBB) with a QRS duration ≥ ۱۳۰ ms, left ventricular ejection fraction ≤ ۳۰%, and NYHA Functional Class II. NYHA Functional Class I, II, or III
and who have left ventricular ejection fraction ≤ ۵۰% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post-implant.
A complete SureScan CRT-D system is required for use in the MR environment. A complete SureScan CRT-D system includes the following components:
- The Amplia MRI CRT-D device
- A SureScan right atrial pacing lead or a Model 6725 pin plug for the right atrial port
- A SureScan left ventricular pacing lead
- A SureScan defibrillation lead
When a single coil SureScan defibrillation lead is used, a Medtronic DF-1 pin plug must be secured in the SVC port to make a complete SureScan DF-1 defibrillation system. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan.
LEAD INTEGRITY ALERT
The RV Lead Integrity Alert feature is intended primarily for patients who have a Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data. The RV LIA feature may not perform as well with a St. Jude Medical Riata™/Durata™ lead or a Boston Scientific Endotak lead as it does when used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and conditions that may or may not be detected early by the RV LIA feature.