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Fill out the form below to access Dr. Vijayaraman's presentation: "LBBAP Clinical Results with Abbott's Stylet-Driven Leads and the Role of AutoCapture™ Algorithm" to learn about left bundle branch area pacing (LBBAP) and Abbott's market-leading LBBAP solutions. Uncover the advantages of continuous unipolar pacing and impedance monitoring, UltiPace™ Pacing Lead's robust distal lead construction, and the Helix Locking Tool.
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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.
UltiPace™ Pacing Leads
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.
DF-4 Helix Locking Tool
Intended Use/ Indication for Use: The DF-4 Helix Locking Tool is intended to aid with lead fixation by providing control over the extension and retraction of the lead helix of a DF4 pacing or defibrillator lead. It is also intended to facilitate insertion of a stylet into the lead through the connector pin.
Warnings: When using the tool, do not rotate the lead terminal pin more than the maximum number of turns recommended by the lead manufacturer. Continuing to rotate the terminal pin can cause lead damage, lead dislodgement, tissue trauma, and/or voltage thresholds to rise. Remove the tool from the lead terminal pin before placing the lead terminal pin in the patient and securing the lead and/or connecting the lead to a pacemaker/defibrillator. For single use/single procedure only. Do not reuse, reprocess, or resterilize. Such may cause failure of the tool and/or infection or cross-contamination. Do not expose the tool to the MR environment. Testing has not been performed to establish safe use in this environment.
Precautions: Read these instructions and consult the literature provided by the lead manufacturer prior to use. Inspect the tool and its packaging prior to use. Do not use if the package is open or there is any evidence of package or tool damage. Store in a cool, dark, dry location.
Complications: Possible complications associated with use of the DF-4 Helix Locking Tool include, but are not limited to, delay in procedure, lead dislodgement, device incompatibility and/or incomplete therapy.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and potential adverse events.
Manufactured by:
CenterPoint Systems LLC
3338 Parkway Blvd West Valley City, UT 84119, U.S.A.
Tel: +1-877-848-0828
[email protected]
Distributed by:
Abbott Medical
15900 Valley View Court Sylmar, CA 91342 USA
+1-818-362-6822
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.
UltiPace™ Pacing Leads
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.
DF-4 Helix Locking Tool
Intended Use/ Indication for Use: The DF-4 Helix Locking Tool is intended to aid with lead fixation by providing control over the extension and retraction of the lead helix of a DF4 pacing or defibrillator lead. It is also intended to facilitate insertion of a stylet into the lead through the connector pin.
Warnings: When using the tool, do not rotate the lead terminal pin more than the maximum number of turns recommended by the lead manufacturer. Continuing to rotate the terminal pin can cause lead damage, lead dislodgement, tissue trauma, and/or voltage thresholds to rise. Remove the tool from the lead terminal pin before placing the lead terminal pin in the patient and securing the lead and/or connecting the lead to a pacemaker/defibrillator. For single use/single procedure only. Do not reuse, reprocess, or resterilize. Such may cause failure of the tool and/or infection or cross-contamination. Do not expose the tool to the MR environment. Testing has not been performed to establish safe use in this environment.
Precautions: Read these instructions and consult the literature provided by the lead manufacturer prior to use. Inspect the tool and its packaging prior to use. Do not use if the package is open or there is any evidence of package or tool damage. Store in a cool, dark, dry location.
Complications: Possible complications associated with use of the DF-4 Helix Locking Tool include, but are not limited to, delay in procedure, lead dislodgement, device incompatibility and/or incomplete therapy.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions, and potential adverse events.
Manufactured by:
CenterPoint Systems LLC
3338 Parkway Blvd West Valley City, UT 84119, U.S.A.
Tel: +1-877-848-0828
[email protected]
Distributed by:
Abbott Medical
15900 Valley View Court Sylmar, CA 91342 USA
+1-818-362-6822
MAT-2615231 v3.0 | Item approved for US use only.