Fully Integrated CRT Implant System
 

Indications, Safety, and Warnings

Medtronic Attain Ability Model 4196, Ability Plus Model 4296, and Ability Straight 4396 Leads

Steroid eluting, dual electrode, transvenous, over the wire, cardiac vein pacing leads. The Model 4396 lead has tined fixation.

Indications

The Attain Ability Models 4196, 4296, and 4396 steroid eluting, dual electrode, IS-1, transvenous leads are indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar pacing is available using these leads in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead.

Additionally, unipolar pacing is available using the leads in combination with a compatible CRT-P system.

Contraindications

Coronary vasculature – The leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Steroid use – Do not use in patients for whom a single dose of 232 µg of dexamethasone acetate cannot be tolerated.

Warnings and Precautions

The Model 4196, 4296, and 4396 leads were designed for optimal pacing when used in a unipolar or extended bipolar configuration. The standard bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.

Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical studies for these leads were not designed to evaluate the removal of left ventricular leads from the coronary venous vasculature.

Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators (ICDs) should generally be explanted.

People with metal implants such as pacemakers, ICDs, and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.

Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending, kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet may cause permanent damage to the lead. When using Model 4196, 4296, or 4396 leads, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Other stylets may extend beyond the lead tip, causing lead tip seal damage or injury or perforation of the cardiac vein or heart. Rust stylets are not recommended with this lead due to the risk of conductor coil or insulation perforation.

Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the guide wire for additional information on guide wires.

Do not use magnetic resonance imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.

For the Model 4196, 4296, or 4396 leads, total patient exposure to dexamethasone acetate should be considered. Drug interactions of dexamethasone acetate with this lead have not been studied. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone acetate apply to the use of this highly localized, controlled-release lead. For a list of potential adverse effects, refer to the Physician’s Desk Reference.

Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the heart.

Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced during the post-implant testing. Backup pacing should be readily available during implant. Use of the delivery system or leads may cause heart block.

To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein, keep the stylet withdrawn 1 to 2 cm or select a more flexible stylet.

Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire without the guide wire insertion tool could cause damage to the lead tip seal or to the conductor core or insulation.

During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents.

Potential Complications

Potential complications related to the use of tranvenous leads include, but are not limited to the following patient-related conditions: cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.


Medtronic Attain 4194 Lead

Indications

The Attain 4194 steroid eluting, IS-1 transvenous lead is indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead.

Contraindications

  • Coronary vasculature – This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
  • Steroid use – Do not use in patients for whom a single dose of of 1.0 mg dexamethasone sodium phosphate cannot be tolerated.


Warnings and Precautions

The Model 4194 was designed for optimal pacing when used in a bipolar configuration. The standard bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.

  • Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical study was not designed to evaluate the removal of left ventricular leads from the coronary venous vasculature.
  • Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.
  • People with metal implants such as pacemakers, Implantable Cardioverter Defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.
  • Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending, kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet may cause permanent damage to the lead. When using the Model 4194, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Other stylets may extend beyond the lead tip causing lead tip seal damage or injury, or perforation of the cardiac vein or heart. Rust stylets are not recommended with this lead due to the risk of conductor coil or insulation perforation.
  • Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the guide wire for additional information on guide wires.
  • Do not use Magnetic Resonance Imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.
  • For the Model 4194 lead, total patient exposure to dexamethasone sodium phosphate should be considered. Drug interactions of dexamethasone sodium phosphate with this lead have not been studied. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate apply to the use of this highly localized, controlled-release lead. For a list of potential adverse effects, refer to the Physicians’ Desk Reference.
  • Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the heart.
  • Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced during the post-implant testing.
  • Backup pacing should be readily available during implant. Use of the delivery system or leads may cause heart block.
  • To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein, keep the stylet withdrawn 1 to 2 cm or select a more flexible stylet.
  • Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire without the guide wire insertion tool could cause damage to the lead tip seal or to the conductor core or insulation.
  • During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents.


Potential Complications

Potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions: cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.


Medtronic Attain StarFix 4195 Lead

Indications

The Attain StarFix Model 4195 steroid-eluting, transvenous lead with deployable lobes is intended for chronic pacing and sensing of the left ventricle via a cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.

Contraindications

This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. Do not use in patients for whom a single dose of 30 μg (micrograms) of beclomethasone dipropionate (BDP) cannot be tolerated.

Warnings and Precautions

  • Leads, stylets, and guide wires should be handled with great care at all times. When using the Model 4195 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Verify that the stylet does not extend beyond the lead tip prior to inserting the lead in the delivery system. Implanting the lead with the stylet extending beyond the lead tip could cause injury or perforation of the cardiac vein or heart.
  • Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities
  • Back-up pacing should be readily available during implant. Use of leads may cause heart block.
  • For the Attain StarFix Model 4195 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 4195 lead have not been studied.
  • People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.
  • Do not use magnetic resonance imaging (MRI) on patients who have this device. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.
  • Always use an acute retention clip to reposition or remove the lead. Always attempt to undeploy the lobes before repositioning or removing the lead. If a lead must be removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute retention clip.
  • Previously implanted pulse generators, implantable cardioverter defibrillators, and leads should generally be explanted


Extraction Warning

The risk and difficulty of removing the Medtronic Attain StarFix Model 4195 lead after a long implant time has not been studied. In light of the novel fixation mechanism of the Model 4195 lead, there may be unique risk and difficulty associated with chronic removal. If a lead must be removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute retention clip.

Potential Complications

Potential clinical complications resulting from the use of transvenous leads include, but are not limited to, the following: air embolism, avulsion of the endocardium, valve, or vein, cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis and pericarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic embolism, and valve damage.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.


Last updated: 15 Jun 2011