Cardiac Resynchronization Therapy Devices

Indications, Safety & Warnings

Entrant and Gallant HF Cardiac Resynchronization Therapy-Defibrillators (CRT-D)

Rx Only

Intended Use: The Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right and left ventricles.
The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.

Indications: The CRT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony.
In addition, CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.
MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.
The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.

Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.
No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.

Quadra Allure

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your Abbott representative for product availability in your country.

Indications: Implantation of Quadra Allure MP RF device is indicated for: maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure, the reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, implantation of Assurity™, Endurity™ and Allure™ family of devices is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms.
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression™ algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. Atrial Fibrillation Allure™ devices are contraindicated in patients having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate. For specific contraindications associated with individual modes, refer to the programmer’s on-screen help.

Potential Adverse Events: The following are potential complications associated with the use of any pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma, bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead dislodgement or reaction at the electrode/ tissue interface, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation), loss of normal device function due to battery failure or component malfunction, pacemaker migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax, endocarditis, excessive bleeding, induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub, pulmonary edema, rise in threshold and exit block, valve damage, cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, coronary sinus or cardiac vein thrombosis.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Quadra Assura™

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

Adverse Events: Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to: component failure, device-programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionising radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by: multiple counting of cardiac events including T waves, P waves or supplemental pacemaker stimuli. Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing and fear of losing pulse capability.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.