Cardiac Leads

Our lead portfolio is built on years of proven reliable lead technology. We design for superb deliverability, stability and performance.

References

1. Abbott. Data on File, Engineering Technical Report. Item: 90994484 Ver D.
2. Abbott. Data on File. Item: 91010074 Ver A.
3. Jenney, C., Tan, J., Karicherla, A., Burke, J., & Helland, J. (2005). A new insulation material for cardiac leads with potential for improved performance. Heart Rhythm, 2, S318-S319. https://dx.doi.org/doi:10.1016/j.hrthm.2005.02.1004
4. St. Jude Medical. Test Report No. 50009843.
5. Data compiled from clinical study results, on file at St. Jude Medical in Report 60034670.
6. Jenney, C., Tan, J., Karicherla, A., Burke, J., & Helland, J. (2005). A new insulation material for cardiac leads with potential for improved performance. Heart Rhythm, 2, S318-S319. https://dx.doi.org/doi:10.1016/j.hrthm.2005.02.1004

Indications, Safety and Warnings

UltiPace Pacing Leads

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 Events: 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.

Durata
Family of Defibrillation Leads

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications and Usage: The Durata lead is intended for permanent sensing and pacing of the right ventricle and the delivery of cardioversion/defibrillation therapy when used with a compatible Abbott pulse generator.

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.

Adverse Events: Potential adverse events include: cardiac tamponade, hemorrhage, pneumothorax, air embolism, venous thrombosis and/or obstruction, tissue necrosis, tricuspid valve dysfunction, infection.

Quartet
Family of LV Leads

Rx Only

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications and Usage: The Quartet lead is intended for permanent sensing and pacing of the left ventricle when used with a compatible Abbott biventricular system.

Contraindications: The use of the Quartet lead 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.

Adverse Events: Potential adverse events associated with the use of left ventricular leads include: 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, myocardial irritability, myopotential sensing, pectoral/diaphragmatic/phrenic nerve stimulation, pericardial effusion, pericardial rub, pneumothorax/hemothorax, pulmonary edema, thrombolytic or air embolism, valve damage.

Tendril STS Pacing Leads

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: 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 associated with the use of Tendril STS 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

Tendril MRI

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: Tendril MRI™ Model LPA1200M leads are designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of a passive lead is suspected to be unstable. In atrial applications, the use of screw-in leads such as Tendril MRI leads may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

Contraindications: Tendril MRI Model LPA1200M leads are contraindicated: in the presence of tricuspid atresia, for patients with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

Adverse Events: Potential complications associated with the use of Tendril MRI Model LPA1200M leads are the same as with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation, embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis.

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