Indications, Safety and Warnings
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.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Abbott ICM (Assert-IQ™ ICM and Jot Dx™ ICM)
Indications for Use: The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.
Intended Use: The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.
Contraindications: There are no known contraindications for the insertion of the Assert-IQ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation, and migration.
Refer to the User’s Manual for detailed indications for use, contraindications, warnings, precautions and potential adverse events.
An Abbott mobile transmitter is available for patients without their own compatible mobile device.
Assert-IQ ICM
Indications for Use: The Assert-IQ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.
Intended Use: The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.
Contraindications: There are no known contraindications for the insertion of the Assert-IQ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation, and migration.
Refer to the User’s Manual for detailed indications for use, contraindications, warnings, precautions and potential adverse events.
An Abbott mobile transmitter is available for patients without their own compatible mobile device.
Assurity MRI™ pacemaker
Indications: Implantation is indicated in one or more of the following permanent conditions, or any combination of these symptoms: syncope, presyncope, fatigue, disorientation. 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-degree 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 AV block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression™ algorithm stimulation 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). Dual-chamber pulse generators 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™ algorithm 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.
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 a device due to programmer or device malfunction; infection; erosion; interruption of desired device 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; device migration and pocket erosion; endocarditis; excessive bleeding; induced atrial or ventricular arrhythmias; myocardial irritability; pericardial effusion; pericardial rub; pulmonary edema; rise in threshold and exit block; valve damage; death.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
AVEIR™ DR Dual Chamber Leadless Pacemaker System
Indications for Use: The AVEIR™ Leadless Pacemaker system is indicated for management of one or more of the following chronic clinical presentations: syncope, pre-syncope, fatigue, disorientation, and one or more of the indications which follow. 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 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 AV block or sinus arrest, chronic atrial fibrillation. MR Conditional: The AVEIR Leadless Pacemaker is conditionally safe for use in the MRI environment and according to the instructions in the MRI-Ready Leadless System Manual.
Intended Use: The AVEIR™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and the right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.
The AVEIR™ Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.
Contraindications: Use of the AVEIR™ Leadless Pacemaker is contraindicated in these cases:
Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.
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.
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor driven rates.
Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.
Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in the Product Materials section of the IFU) contained in the device and a thorough history of allergies must be discussed.
Adverse Events: Potential complications associated with the use of the AVEIR™ Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: cardiac perforation; cardiac tamponade; pericardial effusion; pericarditis; endocarditis; thrombus formation; thromboembolism; valve damage or regurgitation; heart failure; pneumothorax/hemothorax; cardiac arrhythmias; diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation; palpitations; hypotension; syncope; cerebrovascular accident; infection; hypersensitivity reaction to device materials, contrast media, medications, or direct toxic effect of contrast media on kidney function; pacemaker syndrome; inability to interrogate or program the LP due to programmer or LP malfunction; intermittent or complete loss of capture, pacing or sensing (non-battery related); oversensing; increased capture threshold; inappropriate sensor response; corrupted, intermittent, or loss of i2i communications; interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic; battery malfunction/ premature battery depletion; device-related complications (premature deployment, device dislodgement/embolization of foreign material, inability to release/re-dock of the LP from catheter, helix distortion); additional surgery or intervention; death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: vascular access complications, such as perforation, dissection, puncture, groin pain; bleeding or hematoma; thrombus formation; thromboembolism; air embolism; local and systemic infection; peripheral nerve damage; general surgery risks and complications from comorbidities; such as dyspnea, respiratory failure, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
CPS Locator™ 3D Catheters
Indications for Use: The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
Contraindications: Obstructed or inadequate vasculature for venous access.
Complications: Possible complications include, but are not limited to, the following: exposure to x-ray radiation, adverse or allergic reaction to contrast agents, infection, hematoma, pneumothorax, embolization, vessel thrombosis, dissection, acute occlusion, clot formation, hemorrhage, vessel rupture, arrhythmia or heart block, hemodynamic changes, myocardial infarction, perforation of the heart, cardiac tamponade, stroke, and death.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and potential complications.
Manufactured by:
CenterPoint Systems LLC
3338 Parkway Blvd West Valley City, UT 84119, U.S.A.
Tel: +1-877-848-0828
Info@centerpoint-systems.com
Distributerd by:
Abbott Medical
15900 Valley View Court Sylmar, CA 91342 USA
+1-818-362-6822
Durata™ Family of Defibrillation Leads
Durata™ Defibrillation Leads (Models 7120, 7121, 7122)
Indications: The Durata™ Models 7120, 7121, and 7122 defibrillation leads are indicated for use in combination with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy-defibrillators (CRT-Ds) to provide sensing, pacing and cardioversion/defibrillation therapy for the treatment of bradyarrhythmia's and life-threatening tachyarrhythmias in patients who are at risk from sudden cardiac death. They are implanted transvenously in the right ventricle.
Intended Use: The Durata™ leads are implantable defibrillation leads intended for use with a compatible pulse generator to provide long-term cardiac sensing, pacing, and delivery of cardioversion/defibrillation therapy to treat life threatening ventricular arrhythmias in the right ventricle.
Contraindications: Durata™ leads are contraindicated in the following: patients with tricuspid valvular disease or a mechanical tricuspid valve; patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction; patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated.
Potential Adverse Events: The following lists potential adverse effects and their categories as applicable when using a high voltage lead. Arrhythmia (Arrhythmia acceleration, Induced atrial ectopy or arrhythmias, Induced atrioventricular or bundle branch block, Induced ventricular ectopy or arrhythmias, Myocardial irritability), Cardiac perforation (Cardiac tamponade, Perforation of the myocardium, Pericardial effusion), Death, Embolism (Air embolism, Intravascular foreign body, Dislodgement of intracardiac thrombus), Extracardiac stimulation (Diaphragmatic stimulation, Stimulation of phrenic nerve), Heart failure (Cardiogenic shock, Right ventricular decompensation, Pacing induced cardiomyopathy, Tricuspid valve dysfunction), Hemorrhage (Acute hemorrhage/bleeding), Hypersensitivity (Hypersensitivity, including local tissue reaction or allergic reaction), Infection (Endocarditis, Pericarditis), Lead revision or reprogramming (Electrical malfunction of the lead, Lead dislodgement, Lead dysfunction (sensing/threshold issue), Mechanical malfunction of the lead, Inappropriate defibrillation therapy), Pleural perforation (Hemothorax, Pneumothorax), Pocket Erosion (Erosion of the skin, Extrusion), Prolonged exposure to fluoroscopic radiation, Seroma (Fluid accumulation), Tissue necrosis, Tricuspid valve perforation, Vascular perforation (Arteriovenous fistula, Arterial perforation, Coronary sinus or coronary vein perforation, Hematoma, Venous perforation), Vascular Thrombosis (Venous thrombosis and/or obstruction, Venous occlusion).
Durata™ Defibrillation Leads (Models 7120Q, 7121Q, 7122Q)
Indications/Intended Use: The Durata™ Models 7120Q, 7121Q, and 7122Q leads are 7 French, transvenous, steroid eluting, bipolar, DF4 compatible (single connector with four electrical terminals), active fixation leads intended for permanent sensing and pacing of the right ventricle and the delivery of cardioversion/defibrillation therapy when used with a compatible Abbott Medical pulse generator with a DF4-LLHH lead receptacle designation.
Contraindications: Durata™ leads are contraindicated in the following: patients with tricuspid valvular disease or a mechanical tricuspid valve; patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction; patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated; for use with extra firm (red color knob) stylets.
Potential Adverse Events: Possible adverse events associated with the use of transvenous lead systems include, but are not limited to: Dislodgement, breaching of the lead insulation, connector fracture, poor connection to the pulse generator, electrode fracture, or conductor is continuity (Intermittent or continuous loss of sensing, possibly resulting immunodetection of arrhythmia; oversensing of artifact, possibly causing inappropriate delivery of therapy from the pulse generator; intermittent or continuous loss of defibrillation, cardioversion, or pacing therapy; possible muscle or nerve stimulation in the pocket area; intermittent or continuous loss of cardioversion/defibrillation therapy, sensing, or pacing therapies); Cardiac perforation (Intermittent or continuous loss of sensing, cardiac tamponade, hemorrhage, pneumothorax, or loss of contractility); Venous perforation (Acute hemorrhage (may not be readily apparent), hemothorax, pneumothorax, or cardiac tamponade); Myocardial irritability (Premature ventricular contractions, supraventricular and ventricular tachyarrhythmias, postoperative heart failure); Transvenous implantation procedure (Air embolism); Chronic (> 3 months) implantation (Venous thrombosis and/or obstruction, tissue necrosis, skin erosion, tricuspid valve dysfunction, chronic mechanical stimulation of the heart); Contamination (Infection requiring removal of lead system, pulse generator, or both); Post-shock rhythm disturbances (Post-shock bradycardia or supraventricular arrhythmias, conduction disturbances); Threshold elevation or exit block (Loss of efficacy of defibrillation, cardioversion, or pacing therapy); Shunting or insulating of current during defibrillation with internal or external paddles (Increased external defibrillation energy and/or repositioning of paddles required).
Durata™ Defibrillation Leads (Models 7170, 7171)
Indications/Intended Use: The Durata™ Models 7170 and 7171 transvenous leads are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.
Contraindications: Durata™ Models 7170 and 7171 leads are contraindicated in the following: patients with tricuspid valvular disease or a mechanical tricuspid valve; patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction; patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated.
Potential Adverse Events: Possible adverse events associated with the use of transvenous lead systems include, but are not limited to: Dislodgement, breaching of the lead insulation, connector fracture, poor connection to the pulse generator, electrode fracture, or conductor discontinuity (Intermittent or continuous loss of sensing, possibly resulting in nondetection of arrhythmia; oversensing of artifact, possibly causing inappropriate delivery of therapy from the pulse generator; intermittent or continuous loss of defibrillation, cardioversion, or pacing therapy; possible muscle or nerve stimulation in the pocket area; intermittent or continuous loss of cardioversion/defibrillation therapy, sensing, or pacing therapies); Cardiac perforation (Intermittent or continuous loss of sensing, cardiac tamponade, hemorrhage, pneumothorax, or loss of contractility); Venous perforation (Acute hemorrhage (may not be readily apparent), hemothorax, pneumothorax, or cardiac tamponade); Myocardial irritability (Premature ventricular contractions, supraventricular and ventricular tachyarrhythmias, postoperative heart failure); Transvenous implantation procedure (Air embolism); Chronic (> 3 months) implantation (Venous thrombosis and/or obstruction, tissue necrosis, skin erosion, tricuspid valve dysfunction, chronic mechanical stimulation of the heart); Contamination (Infection requiring removal of lead system, pulse generator, or both); Post-shock rhythm disturbances (Post-shock bradycardia or supraventricular arrhythmias, conduction disturbances); Threshold elevation or exit block (Loss of efficacy of defibrillation, cardioversion, or pacing therapy); Shunting or insulating of current during defibrillation with internal or external paddles (Increased external defibrillation energy and/or repositioning of paddles required).
Durata™ Defibrillation Leads (Models 7170Q, 7171Q, 7172Q)
Indications/Intended Use: Durata™ Models 7170Q, 7171Q, and 7172Q leads are 7 French, transvenous, steroid eluting, bipolar, DF4 compatible (single connector with four electrical terminals), passive fixation leads intended for permanent sensing and pacing of the right ventricle and the delivery of cardioversion/defibrillation therapy when used with a compatible Abbott Medical pulse generator with a DF4‑LLHH lead receptacle designation.
Contraindications: Durata™ leads are contraindicated in the following: patients with tricuspid valvular disease or a mechanical tricuspid valve; patients with ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction; patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated.
Potential Adverse Events: Possible adverse events associated with the use of transvenous lead systems include, but are not limited to: Dislodgement, breaching of the lead insulation, connector fracture, poor connection to the pulse generator, electrode fracture, or conductor discontinuity. (Intermittent or continuous loss of sensing, possibly resulting in nondetection of arrhythmia oversensing of artifact, possibly causing inappropriate delivery of therapy from the pulse generator; intermittent or continuous loss of defibrillation, cardioversion, or pacing therapy; possible muscle or nerve stimulation in the pocket area; intermittent or continuous loss of cardioversion/defibrillation therapy, sensing, or pacing therapies); Cardiac perforation (Intermittent or continuous loss of sensing, cardiac tamponade, hemorrhage, pneumothorax, or loss of contractility); Venous perforation (Acute hemorrhage (may not be readily apparent), hemothorax, pneumothorax, or cardiac tamponade); Myocardial irritability (Premature ventricular contractions, supraventricular and ventricular tachyarrhythmias, postoperative heart failure); Transvenous implantation procedure (Air embolism); Chronic (> 3 months) implantation (Venous thrombosis and/or obstruction, tissue necrosis, skin erosion, tricuspid valve dysfunction, chronic mechanical stimulation of the heart); Contamination (Infection requiring removal of lead system, pulse generator, or both); Post-shock rhythm disturbances (Post-shock bradycardia or supraventricular arrhythmias, conduction disturbances); Threshold elevation or exit block (Loss of efficacy of defibrillation, cardioversion, or pacing therapy); Shunting or insulating of current during defibrillation with internal or external paddles (Increased external defibrillation energy and/or repositioning of paddles required).
Ellipse™ ICD
Dual-Chamber
CD2411-36Q
Indications and Usage: Ellipse™ is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT‑Ds are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Ellipse™ ICD
Single-Chamber
CD1411-36Q
Indications and Usage: Ellipse™ is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT‑Ds are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Endurity™ Dual- and Single-Chamber
Pacemaker System
Indications
Implantation is indicated in one or more of the following permanent conditions, or any combination of these symptoms: syncope, presyncope, fatigue, disorientation. 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 stimulation is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
Contraindications
Single-chamber and dual-chamber pulse generators 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 algorithm 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. add statement: 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; device migration and pocket erosion; endocarditis; excessive bleeding; induced atrial or ventricular arrhythmias; myocardial irritability; pericardial effusion; pericardial rub; pulmonary edema; rise in threshold and exit block; valve damage; death.
Entrant™ and Gallant™ HF CRT-D
Intended Use: The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. In addition, these devices can detect and treat: chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle; various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or right atrium. CRT-D devices sense cardiac activity and provide pacing 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 ICD devices are indicated in patients who have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). Cardiac Resynchronization Therapy (CRT) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (LVEF) and a prolonged QRS duration. CRT-D devices are indicated in patients who meet the CRT indications and have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). The device is most commonly implanted within a device pocket in the pectoral region.
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.
No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.
‡ No minimum length of time requirement between implant and MRI scan. Stability of pacing capture thresholds is required prior to MRI scan
* MR conditional with our UltiPace™ Pacing Lead in the left bundle branch area (LBBA) using LV IS-1 port with Gallant™ and Entrant™ CRT-D models. For additional information about specific MR Conditional ICDs, leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events, please refer to Abbott MRI-Ready Systems Manual at manuals.eifu.abbott.
** No Loss of CRT therapy only applicable for select Gallant models.
Entrant™ and Gallant™ ICD
Intended Use: The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. In addition, these devices can detect and treat: chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle; various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or right atrium. CRT-D devices sense cardiac activity and provide pacing 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 ICD devices are indicated in patients who have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). Cardiac Resynchronization Therapy (CRT) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (LVEF) and a prolonged QRS duration. CRT-D devices are indicated in patients who meet the CRT indications and have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). The device is most commonly implanted within a device pocket in the pectoral region.
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.
No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.
‡ No minimum length of time requirement between implant and MRI scan. Stability of pacing capture thresholds is required prior to MRI scan
* MR conditional with our UltiPace™ Pacing Lead in the left bundle branch area (LBBA) using LV IS-1 port with Gallant™ and Entrant™ CRT-D models. For additional information about specific MR Conditional ICDs, leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events, please refer to Abbott MRI-Ready Systems Manual at manuals.eifu.abbott.
** No Loss of CRT therapy only applicable for select Gallant models.
Fortify Assura DR ICD
Indications and Usage: Fortify Assura™ is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT‑Ds are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Fortify Assura VR ICD
Indications and Usage: Fortify Assura™ is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT‑Ds are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Quadra Allure MP™
Cardiac Resynchronization Therapy Pacemaker
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 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 a single chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions, or any combination of these symptoms: syncope, presyncope, fatigue, disorientation.
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 AV block or sinus arrest; chronic atrial fibrillation; severe physical disability. AF Suppression™ algorithm stimulation 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 algorithm 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. 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.
Quadra Assura MP™
Cardiac Resynchronization Therapy Defibrillator
Indications and Usage: Quadra Assura MP™ is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT‑Ds are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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.
Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Quartet LV Lead
Indications/Intended Use: The Quartet™ leads are 5.1 French, transvenous, steroid eluting, quadripolar, IS4 compatible (single connector with four electrical terminals), passive fixation leads intended for permanent sensing and pacing of the left ventricle when used with a compatible Abbott Medical biventricular system with an IS4‑LLLL lead receptacle designation.
Contraindications: The use of Quartet leads is contraindicated in patients who:
Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate
Are unable to undergo an emergency thoracotomy procedure
Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
Potential Adverse Events: Potential adverse events associated with the use of left ventricular leads include: allergic reaction to contrast media; body rejection phenomena; cardiac/coronary sinus dissection; cardiac/coronary sinus perforation; cardiac tamponade; coronary sinus or cardiac vein thrombosis; death; endocarditis; excessive bleeding; hematoma/seroma; induced atrial or ventricular arrhythmias; infection; lead dislodgment; local tissue reaction, formation of fibrotic tissue; loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the pacing lead; myocardial irritability; myopotential sensing; pectoral/diaphragmatic/phrenic nerve stimulation; pericardial effusion; pericardial rub; pneumothorax/hemothorax; prolonged exposure to fluoroscopic radiation; pulmonary edema; renal failure from contrast media used to visualize coronary veins; rise in threshold and exit block; thrombolytic or air embolism; valve damage. Performance of a coronary sinus venogram is unique to lead placement in the cardiac venous system, and carries risks. Potential complications reported with direct subclavian venipuncture include hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage, and rarely, death.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and adverse events.
Tendril™ STS Pacing Leads
Intended Use: Tendril™ STS Model leads are bipolar, steroid eluting, active fixation implantable leads intended for use with an implantable pulse generator to provide long-term cardiac pacing and sensing in either the right atrium, and/or the right ventricle. They are also intended for long-term sensing and pacing in the left ventricular bundle branch area as an alternative to right ventricular pacing.
Indications: Tendril™ STS leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-P/CRT-D) device to provide sensing and pacing for the management of chronic symptomatic bradycardia and various atrioventricular conduction abnormalities in patients who experience syncope, presyncope, fatigue, or disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. The Tendril STS leads are implanted transvenously in either the right atrium, the right ventricle or the left bundle branch area.
Contraindications: Tendril™ STS Model 2088TC leads are contraindicated: in the presence of tricuspid atresia (if the lead is to be positioned in the right ventricle or left bundle branch area), for patients with mechanical tricuspid valves (if the lead is to be positioned in the right ventricle or left bundle branch area), in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.
Adverse Effects: Potential adverse effects and their categories as applicable when using an Tendril™ STS lead include: Arrhythmia (Accelerated arrhythmia, Induced atrial ectopy or arrhythmias, Induced atrioventricular or bundle branch block, Induced ventricular ectopy or asystole, Myocardial irritability), Cardiac perforation (Cardiac tamponade, Pericardial Effusion, Pericarditis, Septal perforation), Death, Embolism (Air embolus, Dislodgement of intracardiac thrombus, intravascular foreign body), Extra-cardiac stimulation, Heart failure (Right ventricular decompensation, Tricuspid valve dysfunction/Tricuspid valve regurgitation/ insufficiency), Hypersensitivity (Hypersensitivity, including local tissue reaction or allergic reaction), Infection (Endocarditis), Lead revision or reprogramming resulting from, but not limited to, loss of pacing and/ or sensing (Electrical malfunction of the lead, Lead dislodgement, Lead dysfunction (sensing/threshold Issue), Mechanical malfunction of the lead), Lung perforation (Hemothorax, Pneumothorax), Pulmonary edema, Prolonged exposure to fluoroscopic radiation, Respiratory compromise, Tricuspid value perforation, Vascular injury (Arterial perforation, Arteriovenous fistula, Coronary sinus or coronary vein perforation/dissection, Hemorrhage/ Hematoma at device site, Venous perforation, Septal hematoma), Vascular thrombosis/ stenosis/ occlusion.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
UltiPace™ Pacing Lead
Intended Use: UltiPace™ leads are bipolar, steroid eluting, active fixation implantable leads intended for use with an implantable pulse generator to provide long-term cardiac pacing and sensing in either the right atrium, and/or the right ventricle. They are also intended for long-term sensing and pacing in the left ventricular bundle branch area as an alternative to right ventricular pacing.
Indications: UltiPace™ leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-P/CRT-D) device to provide sensing and pacing for the management of chronic symptomatic bradycardia and various atrioventricular conduction abnormalities in patients who experience syncope, presyncope, fatigue, or disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. The UltiPace leads are implanted transvenously in either the right atrium, the right ventricle or the left bundle branch area.
Contraindications: UltiPace™ Model LPA1231 leads are contraindicated: in the presence of tricuspid atresia (if the lead is to be positioned in the right ventricle or left bundle branch area); for patients with mechanical tricuspid valves (if the lead is to be positioned in the right ventricle or left bundle branch area); in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.
Potential Adverse Effects: Potential adverse effects and their categories as applicable when using an UltiPace™ lead include: Arrhythmia (Accelerated arrhythmia, Induced atrial ectopy or arrhythmias, Induced atrioventricular or bundle branch block, Induced ventricular ectopy or asystole, Myocardial irritability), Cardiac perforation (Cardiac tamponade, Pericardial Effusion, Pericarditis, Septal perforation), Death, Embolism (Air embolus, Dislodgement of intracardiac thrombus, intravascular foreign body), Extra-cardiac stimulation, Heart failure (Right ventricular decompensation, Tricuspid valve dysfunction/Tricuspid valve regurgitation/ insufficiency), Hypersensitivity (Hypersensitivity, including local tissue reaction or allergic reaction), Infection (Endocarditis), Lead revision or reprogramming resulting from, but not limited to, loss of pacing and/ or sensing (Electrical malfunction of the lead, Lead dislodgement, Lead dysfunction (sensing/threshold Issue), Mechanical malfunction of the lead), Lung perforation (Hemothorax, Pneumothorax), Pulmonary edema, Prolonged exposure to fluoroscopic radiation, Respiratory compromise, Tricuspid value perforation, Vascular injury (Arterial perforation, Arteriovenous fistula, Coronary sinus or coronary vein perforation/dissection, Hemorrhage/ Hematoma at device site, Venous perforation, Septal hematoma), Vascular thrombosis/ stenosis/ occlusion.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
MAT-2211344 v6.0
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