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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.

Indications for Use: The Volt™ PFA Catheter, Sensor Enabled™ is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent atrial fibrillation when used in conjunction with a compatible pulsed field ablation (PFA) generator. The catheter is compatible with the EnSite™ X EP System. 

Contraindications: The Volt™ PFA Catheter, Sensor Enabled™ is contraindicated for: 

• Patients who have had a ventriculotomy or atriotomy within the preceding four weeks. 
• Patients with prosthetic valves as the catheter may damage the prosthesis. 
• Patients with an active systemic infection as this may increase the risk for cardiac infection. 
• Patients with a myxoma or an intracardiac thrombus as the catheter could precipitate an embolus. 
• Patients unable to receive heparin or an acceptable alternative to achieve adequate anti-coagulation. 

The transseptal approach is contraindicated in a patient with an interatrial baffle or patch because the opening could persist and produce an iatrogenic atrial shunt. The retrograde trans-aortic approach is contraindicated in patients who have had aortic valve replacement. 

Warnings: Misuse of this device may result in serious complications. Do not alter this device in any way. This device is intended for one time use only; do not reprocess or reuse it. Note the product “Use by” date on the package. Any attempt to resterilize and reuse this system may compromise its integrity. Adverse effects of using nonsterile components may include, but are not limited to:  

• Local or systemic infection or reaction 
• Mechanical damage
• Inaccurate functionality.

For both patients and laboratory staff, cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects due to the x-ray beam intensity and duration of the fluoroscopic imaging. Carefully consider the use of this device in pregnant women. This device should be used by physicians trained in the techniques of catheter ablation in a fully equipped electrophysiology laboratory. Do not immerse the proximal handle or cable connectors in fluids; electrical performance could be affected. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Vascular perforation or dissection is an inherent risk of any catheter placement. Careful catheter manipulation must be performed to avoid device component damage, thromboembolism, cerebrovascular accident, cardiac damage, perforation, pericardial effusion, or tamponade. The safety and long-term effects of lesions created by pulse field ablation have not been established. In particular, the long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. The safety and effectiveness of the device has not been established in pregnant women or pre-pubescent children. Careful consideration must therefore be given for the use of the device in pregnant women or prepubescent children. Concurrent use of non-linear catheters within the atrial chamber may increase the risk of entanglement. Catheter entanglement with other device is a possible complication of electrophysiology procedures. To unentangle the Volt™ PFA Catheter, Sensor Enabled™, deflate the balloon and manipulate the opposing catheter to the center of the basket electrodes. Follow any relevant entanglement procedures from the opposing device. Aspiration during catheter introduction or withdrawal is recommended to limit the potential for air ingress into the patient. During catheter preparation, rinsing or submerging the basket in saline reduces the potential for blood coagulation. During catheter preparation, shifting the straightener over the basket removes any residual air remaining in the folds of the balloon and reduces the potential for air embolism. Use of a syringe larger than 12 mL for balloon inflation increases the risk of overinflation. This can result in detachment of the spline electrodes at the distal coupler. Pacemakers and implantable cardioverter/defibrillators can be affected adversely by PFA signals.

It is important to: 

• Have temporary external sources of pacing and defibrillation available during ablation. 
• Deactivate ICDs because they can discharge and injure the patient or even damage the ICDs during the ablation procedure. 
• Exercise extreme caution while ablating near atrial or ventricular permanent pacing leads. 
• Perform complete pacing system analysis on all patients after ablation. 

Precautions: Do not deflect the introducer while the basket is within the deflectable portion of the introducer, as this can cause damage to the introducer deflection mechanism. Do not deflect the Volt™ PFA Catheter, Sensor Enabled™ while the basket is in the introducer, as this can cause damage to the catheter deflection mechanism. The first application of PFA will likely result in a significant reduction of amplitude of PV potentials recorded from the electrodes on the catheter. Do not use this as an immediate indication that no further ablation is necessary. The PFA therapy should be delivered in accordance with the Therapy Delivery Parameters. Advance the catheter slowly through the introducer to minimize the risk of air embolism. Do not attempt to use the device before completely reading and understanding the applicable instructions for use. Inspect the package prior to use. Do not use if the packaging or catheter appears damaged. Inspect all components before use. Excessive bending or kinking of the catheter may cause damage to the catheter. Be careful not to twist the electrodes with respect to the catheter shaft; twisting may damage the electrode bond and loosen the electrodes. Release the steering (make the catheter straight) prior to pulling back the catheter into the introducer. Deflate the balloon before pulling the catheter back into the introducer. Overinflation of the balloon may cause damage to the device. Always straighten the catheter shaft and keep the balloon deflated before insertion or withdrawal. Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired curve. Do not use if the catheter does not hold its curve or if there is difficulty deflecting the catheter. Do not use if there is difficulty inflating or deflating the balloon. Do not use excessive force to advance or withdraw the catheter while inside the introducer when resistance is encountered to avoid potential damage to the catheter. Do not expose catheter to organic solvents such as alcohol. Catheter advancement must be performed with support from visualization modalities such as Intracardiac echo, fluoroscopy, and or compatible navigation and visualization systems to minimize the risk of cardiac damage, perforation, or tamponade. If other catheters are used concomitantly with the Volt™ PFA Catheter, Sensor Enabled™, only use other catheters in close proximity when the balloon is inflated, and never in tandem with the catheter in the same pulmonary vein. Never retract the catheter into the introducer when another catheter is in close proximity. Never use a loop catheter concomitantly with the Volt™ PFA Catheter, Sensor Enabled™ within the same atrial chamber. Retract the catheter into the introducer before using a loop catheter within the same chamber. Prior to therapy delivery, ensure that the guidewire is not touching the basket electrodes to prevent ineffective therapy. Compliance with intended therapy delivery parameters reduces the potential for hemolysis and acute kidney injury. Ensure that vacuum pressure is relieved and balloon is fully deflated. After deflating the balloon, leave the stopcock open between the syringe and the inflation lumen to prevent catheter damage during catheter withdrawal. It is recommended to withdraw the guidewire into the introducer prior to balloon deflation to avoid potential entanglement with spline electrodes. Ensure even spacing for splines and full balloon inflation to reduce potential for generator fault detection. Ensure connection to center lumen stopcock when attempting to inject contrast. The balloon inflation lumen has a blue/grey striped sleeve to visually distinguish it from the center lumen stopcock. Do not touch the guidewire during therapy delivery. Risk of electric shock to the user is possible under rare circumstances in which the guidewire is in contact with an active therapy electrode(s) and the user. During treatment with the catheter, ensure there is no possibility of contact with electrodes from another catheter. To avoid thromboemboli, intravenous heparin should be used when entering the left heart during ablation. Consult the HRS consensus guidelines for anticoagulation strategies pre-, during, and post-catheter ablation. Individual patient anatomy and physician technique may require procedural variations. Maintain an activated clotting time (ACT) of greater than 300 seconds at all times during use of the catheter. Store in a dry place.  After use, the device accessories and packaging should be appropriately classified for disposal, e.g. biohazard, sharps, non-hazardous waste etc., and carefully disposed of in compliance with facility procedures and applicable laws and regulations. Catheter materials are not compatible with magnetic resonance imaging (MRI). 

Potential Adverse Events: The potential adverse events may be related to the ablation catheter(s) and/or the interventional procedure. The severity and/or the frequency of these potential adverse events may vary and may result in prolonged procedure time and/or additional medical and/or surgical intervention, implantation of a permanent device such as a pacemaker, and in rare cases, may result in death. The following adverse events have been documented for catheter ablation procedures: 

• Abnormal vision 
• Acute kidney injury 
• Air embolism 
• Anesthesia reaction 
• Angina/chest pain/discomfort 
• Aorto-right atrial fistula 
• Arrhythmias, including exacerbation of preexisting atrial fibrillation 
• Arteriovenous fistula 
• AV/SA node stunning (asystole) 
• Bleeding, including major bleeding requiring surgery or transfusion/hematomas/anemia 
• Cardiac perforation/tamponade 
• Cardiac embolism 
• Cardiovascular injury, including atrial trauma and coronary artery/pulmonary vein trauma 
• COPD exacerbation 
• Component damage to Implantable Cardioverter Defibrillator(ICD) or implantable pacemaker 
• Coronary artery spasm 
• Cytotoxicity/systemic toxicity/sensitization/endotoxin/pyrogen 
• Death 
• Dislodgement of ICD or pacing leads 
• Electrical shock 
• Endocarditis 
• Esophageal lesion 
• Fever 
• Foreign body embolism 
• Heart block/unintended ablation 
• Heart failure 
• Hemothorax 
• Hypotension 
• Infectious pericarditis 
• Left atrial esophageal fistula 
• Myocardial infarction 
• Neck/back/groin/chest pain/discomfort (general chest pain not associated with MI) 
• Palpitations 
• Pericarditis 
• Pericardial effusion 
• Phrenic nerve injury 
• Peripheral vascular dissection/laceration 
• Pleural effusion 
• Pneumonia 
• Pneumothorax 
• Pseudoaneurysm 
• Pulmonary edema 
• Pulmonary embolism 
• Pulmonary hypertension 
• Pulmonary vein stenosis 
• Radiation injury 
• Respiratory failure/distress/depression/hypoxia 
• Silent cerebral event/lesion 
• Stiff Left Atrial Syndrome 
• Stroke/cerebrovascular accident 
• Syncope/vasovagal reaction/dizziness 
• Transient ischemic attack (TIA) 
• Thromboembolism 
• Thrombosis/thrombus 
• Vagal nerve injury including Gastroparesis 
• Valvular damage or insufficiency

Volt™ PFA System is commercially available in Europe.

CAUTION: This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market.

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.

Rx Only

Indications:

The Perclose™ ProStyle™ Suture-Mediated Closure and Repair System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access sites of patients who have undergone diagnostic or interventional catheterization procedures.

The Perclose™ ProStyle™ SMCR System is indicated for closing the common femoral vein in single or multiple access sites per limb.

The Perclose™ ProStyle™ SMCR System is used without or, if required, with adjunctive manual compression.

For access sites in the common femoral artery using 5F to 21F sheaths. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

For access sites in the common femoral vein using 5F to 24F sheaths. For venous sheath sizes greater than 14F, at least two devices and the pre-close technique are required.

Caution:

Federal law restricts this medical device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott.

Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

During closure of access sites using a procedural sheath greater than 8F, it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to repair the vessel is needed.

Contraindications:

There are no known contraindications to the use of this device.

Warnings:

Do not use the Perclose™ ProStyle™ SMCR System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Perclose™ ProStyle™ SMCR System is intended for single use only.

Do not use the Perclose™ ProStyle™ SMCR System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.

Do not use the Perclose™ ProStyle™ SMCR System in arterial or venous access if the puncture is through the posterior wall or if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.

Precautions:

1. Prior to use, inspect the Perclose™ ProStyle™ SMCR System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.
2. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose™ ProStyle™ SMCR System. Employ appropriate groin management, as per hospital protocol, post-procedure, and post-hospital discharge to prevent infection.
3. Use a single wall puncture technique. Do not puncture the posterior wall of the vessel in arterial and venous access.
4. Do not deploy the Perclose™ ProStyle™ Device at an elevated angle against resistance as this may cause a cuff miss or device breakage.
5. There are no reaccess restrictions if previous arteriotomy / venotomy repairs were achieved with Abbott Medical SMC or SMCR systems.
6. If significant blood flow is present around the Perclose™ ProStyle™ Device, do not deploy needles. Remove the device over a 0.038" (0.97 mm) (or smaller) guide wire and insert an appropriately sized sheath.
7. Prior to depressing the plunger to advance the needles, stabilize the device by the body to ensure the foot is apposed to the vessel wall and the device does not twist during deployment. Twisting (torquing) of the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly depress the plunger. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
8. Do not apply excessive force to the lever when opening the foot and returning the foot to its original position down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.
9. Do not advance or withdraw the Perclose™ ProStyle™ Device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the Perclose™ ProStyle™ Device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
10. If excessive resistance in advancing the Perclose™ ProStyle™ Device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guide wire and reinsert the introducer sheath or use manual compression.
11. Remove the Perclose™ ProStyle™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.
12. Care should be taken to avoid damage to the suture from handling. Avoid crushing damage due to application of surgical instruments such as clamps, forceps or needle holders.
13. For catheterization procedures using a 5F – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
14. For catheterization procedures using a procedural sheath > 8F, use manual compression, compression assisted devices, surgical repair, and / or other appropriate treatment methods in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
15. For catheterization procedures using a procedural sheath > 8F, where the operating physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary vascular surgical intervention.
16. If the Perclose™ ProStyle™ Device is used to close and repair multiple access sites in the same vessel, space the access sites apart adequately to minimize sheath-device interference.

Potential Adverse Events:

Potential adverse events associated with use of vessel closure devices may include, but are not limited to, the following:

• Allergic reaction or hypersensitivity to device components
• Vascular access complications which may require transfusion or vessel repair, including:
  • Anemia
  • Aneurysm
  • Arteriovenous fistula
  • Bleeding / hemorrhage / re-bleeding
  • Bruising
  • Hematoma
  • Embolism
  • Inflammation
  • Intimal tear / dissection
  • Perforation
  • Pseudoaneurysm
  • Retroperitoneal hematoma / bleeding
  • Scar formation
  • Wound dehiscence
• Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
  • Atrial arrhythmias
  • Ventricular arrhythmias
• Femoral artery / venous complications which may require additional intervention, including:
  • Arterial / venous stenosis
  • Arterial / venous occlusion
  • Arteriovenous fistula
  • Intimal tear / dissection
  • Ischemia distal to closure site
  • Nerve injury
  • Numbness
  • Thrombus formation
  • Vascular injury
• Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post-procedure pulmonary embolism)
• Infection - local or systemic
• Pain
• Hemodynamic instability:
  • Hypotension / hypertension
  • Vasovagal episode
• Death
• Device complications
• Device failure
• Device malfunction

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.

Indications: UltiPace™ leads are indicated for use in combination with a compatible pacemakers, implantable cardioverter defibrillator (ICDs) or cardiac resynchronization therapy (CRT-P/CRT-D) to provide sensing and pacing for the management of chronic symptomatic bradycardia and various atrioventricular conduction abnormalities in patients who experience syncope, presyncope, fatigue, 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™ 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 associated with the use of UltiPace™ leads are the same as with the use of other active fixation leads and 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

The physician should discuss the patient's potential adverse events with them.

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

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.

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.

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.

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.