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Electrophysiology

Cobalt™ and Crome™ ICD and CRT-D portfolio

Learn about transvenous implantable cardioverter defibrillators (ICDs) used for tachyarrhythmia management.

Indications, Safety, and WarningsIndicationsThe Cobalt™ XT, Cobalt™, and Crome™ HF CRT-D MRI SureScan™ systems are indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions:

NYHA Functional Class III or IV patients who remain symptomatic despite stable, optimal medical therapy and have LVEF ≤ 35% and a prolonged QRS duration

NYHA Functional Class II patients who have left bundle-branch block (LBBB) with a QRS duration ≥ 130 ms and a left ventricular ejection fraction ≤ 30%

NYHA Functional Class I, II, or III who are on stable, optimal medical therapy (if indicated), and have LVEF ≤ 50%, atrioventricular block (AV block), and are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing

The Cobalt™ XT, Cobalt™, and Crome™ VR and DR ICD MRI SureScan™ systems are indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, atrial and/or life-threatening ventricular arrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies.MRI conditions for useMedtronic SureScan™ ICD and CRT-D systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. ICD and CRT-D SureScan™ system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan™ feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan™ defibrillation system, which is a SureScan™ device with appropriate SureScan™ lead(s), is required for use in the MR environment. To verify that components are part of a SureScan™ system, visit mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan.ContraindicationsThe Cobalt™ XT, Cobalt™, and Crome™ VR and DR ICD and CRT-D MRI SureScan™ systems are contraindicated for use in the following situations:

If implanted with a unipolar pacemaker

If incessant VT or VF exists

If the primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If tachyarrhythmias with transient or reversible causes exist, including the following known issues: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, and sepsis

Warnings and precautionsChanges in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history. The device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region.Potential adverse eventsPotential adverse events include, but are not limited to, the following events: allergic reactions, atrial fibrillation, bradyarrhythmia, cardiac arrest, device migration, discomfort, dizziness, dyspnea, erosion, excessive fibrotic tissue growth, heart failure or loss of CRT (for CRT-D patients), hematoma, hemorrhage, inability to deliver therapy, inappropriate shock, infection, lead migration/dislodgement, lethargy, loss of pacing, mental anguish, necrosis, nerve damage, oversensing, palpitations, seroma, syncope, tachyarrhythmia, tissue damage due to heating of the device, undersensing, and wound dehiscence. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, spontaneous tachyarrhythmia, potential for VT/VF induction, device heating that results in tissue damage, stimulation of the leads that results in continuous capture, VT/VF, hemodynamic collapse, damage to the device or the leads, causing the system to fail or treat the patient’s condition incorrectly, and movement or vibration of the device or the leads, resulting in dislodgement.See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and adverse events. See the MRI SureScan™ technical manual before performing an MRI scan. For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com or mrisurescan.comCaution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_83960

The Cobalt™ and Crome™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy - defibrillator (CRT-D) portfolio is enabled with 40 J energy availability on the first shock and every shock,¹ extended longevity, and BlueSync™ technology, allowing for tablet-based programming and app-based remote monitoring to streamline the patient and provider experience.¹ Select models include intrinsic antitachycardia pacing (iATP) which is the only automated and smart antitachycardia pacing (ATP) algorithm that provides individualized therapy in real time,² exclusive algorithms to manage atrial fibrillation (AF), and compatibility with a simplified heart failure risk stratification tool to help meet the needs of physicians and their patients.

Cobalt™ XT

ICDs and CRT-Ds with an automated ATP algorithm, exclusive algorithms to manage AF, BlueSync™ technology, and compatibility with an automated heart failure risk stratification tool.

View Cobalt™ XT ICD View Cobalt™ XT CRT-D

Cobalt™

ICDs and CRT-Ds with a collection of exclusive algorithms to manage AF, offer BlueSync™ technology, and CRT-Ds compatible with an automated heart failure risk stratification tool.

View Cobalt™ ICD View Cobalt™ CRT-D

Crome™

ICDs and CRT-Ds enabled with BlueSync™ technology, extended longevity, 40 J on all shocks including first shock,¹ and CRT-Ds compatible with an automated heart failure risk stratification tool.

View Crome™ ICD View Crome™ CRT-D

Watch our journey.

Watch the video to learn how our new ICD and CRT-D portfolio is delivering innovation to help meet the needs of patients and physicians.

Shock reduction

Intrinsic ATP™ (iATP) is the only automated and smart ATP algorithm that provides individualized therapy in real time.²

Proven technologies

Discover exclusive algorithms to manage AF patients and optimize CRT delivery that help tailor therapy for each patient’s needs.

Streamlined workflows

ICDs and CRT-Ds enabled with BlueSync™ technology, and CRT-Ds compatible with an automated heart failure risk stratification tool.

Medtronic Cobalt™ XT HF Quad MRI SureScan™ Model DTPA2QQ device manual.
Yee R, Fisher J, Birgersdotter-Green U, et al. Initial clinical experience with a new automated antitachycardia pacing algorithm. Circulation. 2017;10(9):e004823. doi: 10.1161/CIRCEP.116.004823.

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