Tendril™ STS

Pacing leads
Model 2088TC

User's Manual
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to
cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
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© 2023 Abbott. All Rights Reserved.
Device Description
The Tendril™ STS Model 2088TC leads are bipolar, steroid-eluting, active fixation implantable leads with
Optim™ insulation that can be placed in the right atrium, right ventricle, or left bundle branch area for
pacing and sensing. Certain Tendril STS Model 2088TC lead lengths have been tested for use in the MRI
environment and are designated MR Conditional. See MRI Safety Information (page 2).
The active fixation leads use an extendable-retractable helix at the tip. The design of the tip aids visibility
under fluoroscopy. The leads’ insulation tubing is treated with Fast-Pass™ coating to creates a lubricious
surface to facilitate insertion.
Features of Tendril STS Model 2088TC leads include:
▪ Soft Tip Header — reduces lead tip pressure
▪ Optim™ insulation — a silicone-polyurethane copolymer
▪ Tantalum Marker Ring — to facilitate optimal lead positioning
▪ Active Fixation — features a rotating, extendable/retractable helix for secure anchoring
▪ Steroid Elution — Dexamethasone sodium phosphate (DSP) is slowly released through the tip electrode
upon contact with the body fluid. The drug is intended to promote low chronic stimulation threshold by
suppressing the local inflammatory response to a foreign body. The target dose of DSP in the monolithic
controlled device (MCRD) is 460 micrograms.

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.
For indications for the pacing system, please refer to the applicable pulse generator manual.

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.
Table 1. Lead accessories and their intended purpose
Accessories Intended Use

Stylet Stiffen and support the lead to facilitate placement.

Clip-on tool Extend and retract the helix of an active-fixation lead.

Suture sleeve Protect the lead from damage when it is secured to the venous entry site.

Vein pick Lift and dilate the vein at the lead entry site.

Lead cap Insulate and protect the lead connector when it is not connected to a
device.
Helix Locking Tool Extend and retract the helix of an active-fixation lead.

NOTE: These and other accessories may be ordered separately. For more information, contact your local
Abbott Medical representative.

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Intended Clinical Benefits
Tendril™ STS low voltage transvenous pacing leads provide sensing and pacing for the therapeutic
management of chronic symptomatic bradyarrhythmia and various atrioventricular conduction
abnormalities when used in combination with a compatible pulse generator system to relieve symptoms of a
slow heart rate and restore normal blood circulation.
Tendril™ STS pacing leads, when used in combination with a compatible pulse generator system, provide the
following clinical benefit:
▪ sensing and pacing for the therapeutic management of chronic symptomatic bradyarrhythmia and
various atrioventricular conduction abnormalities.

MRI Safety Information

The Abbott Medical MR Conditional lead is part of the Abbott Medical MR Conditional system.
An MR Conditional lead is conditionally safe for use in the MRI environment when used in a complete MR
Conditional system and according to the instructions in the MRI-Ready Systems Manual for the Abbott
Medical MR Conditional system.
Patients with an implanted Abbott Medical MR Conditional system can have an MRI scan if the conditions
for use, as described in the MRI-Ready Systems Manual, are met. Scanning under different conditions may
result in severe patient injury or death or device malfunction.
The following lead lengths have been tested and determined to be MR Conditional when used according to
the instructions in the MRI-Ready Systems Manual. Lead lengths not listed in the table below or listed as
untested have not been tested and their use in an MR environment is not determined.
Table 2. MR Conditional lead lengths for Tendril STS 2088TC leads
Lead Length (cm) MR Status

46 MR Conditional

52 MR Conditional

58 MR Conditional

65 Untested

100 Untested

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.
For contraindications for the pacing system, please refer to the applicable pulse generator manual.

Package Contents
Each package contains product literature and the following sterile components:
▪ One lead
▪ One tip retainer (to be removed prior to implant)
▪ One radiopaque suture sleeve attached to lead

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 ▪ Accessories
– One vein pick
– Two clip-on tools
– Stainless steel stylets with knob colors designating degree of firmness and shape. See Stylet Color
Codes (page 18).
The non-pyrogenic label is applicable to the lead and introducer catheter only and is not applicable to any
other component contained in the lead package.

Warnings and Precautions

▪ Implanted cardiac leads are subjected to a hostile environment within the body due to constant,
complex flexural and torsional forces, interactions with leads and/or the device, or other forces
associated with cardiac contractions and patient physical activity, posture, and anatomical influences.
Cardiac leads' functional lifetimes can be affected by these and other factors.
▪ Patients with implanted leads should avoid diathermy, even if the device is programmed off, as it may
damage tissue around the implanted electrodes or may permanently damage the implantable device
system.
▪ Carefully remove the tip retainer from the lead prior to implantation.
▪ For single use only.
▪ Testing has demonstrated that the Abbott Medical MR Conditional system is conditionally safe for use in
the MRI environment when used according to the instructions in the MRI-Ready Systems Manual.
▪ Lead lengths not listed in the MR Conditional lead lengths table or listed as untested have not been
tested and their use in an MR environment is not determined.
▪ One or more components of this device may contain the following substance defined as CMR 1B in a
concentration above 0.1% weight by weight: Cobalt: Chemical Abstracts Service (CAS) No. 7440-48-4;
EC No. 231‑158‑0.
▪ Current scientific evidence supports that medical devices manufactured from cobalt alloys and stainless
steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.
▪ Persons with known history of allergies to any of the components of the lead may suffer an allergic
reaction. Prior to its use on the patient, the patient should be counselled on the material contained in
the lead and accessories. A thorough history of allergies must be discussed. See the Technical
Specifications section for a list of direct-contacting materials to be disclosed.
CAUTION: Do not use an alligator clip as an indifferent electrode by connecting it directly to tissue.
This can result in tissue trauma and cause inaccurate voltage thresholds and impedance
measurements.

Storage and Handling

▪ Do not stretch, crush, kink or bend the lead. Leads may be damaged by improper handling before and
during implant or by excessive mechanical stress post-implantation.
▪ Do not bring the lead into contact with sharp objects that could puncture or otherwise compromise the
insulation.
▪ Handle the lead only with powderless, sterile surgical gloves.
▪ Avoid handling the lead with any surgical tools such as hemostats, clamps or forceps.
▪ Leads have an electrostatic attraction for particulate matter; do not expose them to lint, dust or other
such materials.
▪ Avoid touching or handling the lead tip electrode itself.
▪ Do not immerse the lead body in mineral oil, silicone oil, alcohol, or any liquid other than sterile saline
or injectable fluid.
▪ Do not immerse the tip electrode in any fluid prior to implantation; immersion of the electrode may
cause a small amount of steroid to be prematurely eluted.

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Maintaining Device Effectiveness
Device Storage
▪ Store the lead and accessories at room temperature between 68°F and 77°F (20°C and 25°C). Excursions
are permitted between 59°F and 86°F (15°C and 30°C). During transportation and handling, the lead and
accessories can be exposed to temperature excursions between 23°F and 122°F (-5°C and 50°C) that last
up to 24 hours.
▪ The lead package has been sterilized with ethylene oxide for direct introduction of the inner tray into
the surgical field.
▪ Before the package is opened, inspect it visually for any damage that may have compromised sterility.

Sterilization Instructions
The package contents have been sterilized with ethylene oxide before shipment. The lead and accessories
are for single use only and are not intended to be resterilized.
▪ If the sterile package has been compromised, contact Abbott Medical.

Lead Implantation
▪ Check the "Use‑By" date on the package label. Do not implant a lead if the "Use-By" date has expired.
▪ Before opening the lead package, confirm that the lead is compatible with the device to be implanted.
▪ Lead implantation should be performed only when proper emergency facilities for cardioversion and/or
defibrillation are available.
▪ The manipulation of any and all hardware while in the vascular system should only be performed under
continuous fluoroscopic monitoring.
▪ During this procedure it is advisable to also have echocardiographic equipment available.
▪ If subclavian venipuncture is used for lead introduction, it is important to insert the lead as lateral as
possible during entry of the lead into the vein.
▪ If removal of the suture sleeve is necessary, use caution when sliding over the electrode rings as lead
damage can occur.
▪ Failure to use the suture sleeve to secure the lead may result in lead dislodgment or in damage to the
lead’s insulation and/or conductor coil.
▪ Pay close attention to the handling of the helix extension/retraction mechanism before and during
implantation.

Potential Adverse Effects

The following table lists potential adverse effects and their categories as applicable when using a
Tendril™ STS lead.
Table 3. Potential Adverse Effects
Adverse Effect Categories
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 —
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 Table 3. Potential Adverse Effects
Adverse Effect Categories
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 ▪ Electrical malfunction of the lead
resulting from, but not limited ▪ Lead dislodgement
to, loss of pacing and / or ▪ Lead dysfunction (sensing/threshold Issue)
sensing
▪ 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.

Conformance to Standards
The lead complies with IS-1 connector standard ISO 5841-3.

Clinician Use Information

Physician Training
Physicians should be familiar with sterile implant procedure and follow-up evaluation.
The following sections describe various stages of lead implantation. Procedures included in these sections
are only recommendations. Actual implant procedures are left to the discretion of the implanting physician.

Directions for Use

Preparation
Before implanting the lead:
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 ▪ Confirm compatibility between the device and the lead and review the implantation instructions
▪ Select an appropriate venous route
▪ Select and install an appropriate stylet
▪ Select and prepare the delivery system (if one is required)
▪ Test the mechanical function of the helix
▪ Confirm the helix is completely retracted before implantation.
CAUTION:
▪ Do not use excessive force while inserting the stylet.
▪ When subclavian venipuncture is used for lead introduction, it is important to insert the lead as
lateral as possible during entry of the lead into the vein.
▪ Avoid positioning the lead so that it becomes sharply bent or subjected to tension.
▪ Do not grip the lead with surgical instruments.

Testing the Mechanical Operation of the Helix with the Clip-On Tool
For information on using the clip-on tool, see Securing the Tip (page 9).

The Helix Locking Tool

The accessory Helix Locking Tool is designed to aid with lead fixation by providing control over the extension
and retraction of the helix. This can be an alternative to the clip-on tool.
Figure 1. Helix Locking Tool

Using the Vein Pick

A vein pick is a transitory contacting device intended to facilitate the introduction of the lead into a free-
standing vein. Insert the tip of the vein pick into the vein incision and gently lift it while introducing the lead
underneath, into the vein.
Figure 2. Vein pick

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Using the Lead Introducer
If a lead introducer is used, follow the instructions provided with the introducer.
CAUTION:
▪ If using a percutaneous lead introducer with a hemostasis valve, make sure the valve allows for
appropriate passage of the lead without damaging the lead body.
▪ Be certain the vein pick does not puncture the insulation of the lead. This could prevent proper
lead function.
▪ Do not use excessive force while inserting the stylet.
▪ When subclavian venipuncture is used for lead introduction, it is important to insert the lead as
lateral as possible during entry of the lead into the vein.
▪ Avoid positioning the lead so that it becomes sharply bent or subjected to tension.
▪ Do not grip the lead with surgical instruments.
▪ Do not leave a lead unconnected in a patient unless the lead is capped.

Positioning the Lead

Confirm that the helix is completely retracted before implantation.
NOTE: If blood clogs the helix, repositioning may require a greater number of pin rotations to extend the
helix. Repeated repositioning attempts may impair the helix extension mechanism.

Atrial Lead Placement

1. Using a straight stylet, introduce the lead into the atrium so that it rests on the floor of the atrial
chamber.
2. Replace the straight stylet with a J-shaped stylet, or withdraw the existing stylet, bend it into a soft J-
shape, and reinsert the curved stylet into the lead.
3. As the stylet approaches the electrode tip, introduce more lead to ensure that the tip remains in the
atrium as the lead takes its J-shaped.
4. Retract the lead as necessary to ensure that the electrode tip slides into the atrial appendage. Observe
the fluoroscopy monitor to verify that the “J” is straightening.
5. When the lead is past the appendage and in the chamber, feed more lead into the heart so that it
regains its J-shaped.
6. Take a firm grip on the stylet, then introduce more of the lead so that the electrode tip goes as far as
possible into the atrium. On fluoroscopy, the electrode tip will “tilt over” as proof that it can go no
further.
7. With the clip-on tool or the Helix Locking Tool, extend the helix so that the lead is fixed to the atrial wall
(page 8).
8. Retract the entire stylet from the lead with a smooth and steady motion.
9. Check that the lead is properly anchored by introducing more of it into the heart until the loop that
forms either lies on the bottom of the atrium, or is about to enter the inferior vena cava or the right
ventricle. Retract any excess lead until it acquires the correct J-shaped.
Figure 3. Atrial lead placement

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10. Ask the patient to breathe deeply and check that the lead keeps its J-shape.
11. Ask the patient to cough to ensure that the electrode is securely anchored.

Ventricular Lead Placement

1. Advance the lead into the atrium.
2. Pull the stylet back a few centimeters to reduce the risk of the lead damaging the valves or penetrating
the heart muscle when it continues down into the ventricle.
3. Continue to advance the lead. When the tip reaches the apex, retract the stylet an additional ten
centimeters or more.
4. With the clip-on tool or the Helix Locking Tool, extend the helix to fix the lead tip to the ventricular wall.
If the tip is correctly secured, the lead will be felt to jerk slightly.
5. Remove the stylet completely. Adjust the lead so that it lies in the desired position in the ventricle.
Figure 4. Ventricular lead placement

Securing the Tip

Securing the Tip with the Clip-On Tool
Insert the stylet into the lead and pinch open the clip-on tool. Place the lead terminal pin into the open
notch of the clip-on tool so that the pin snaps into place and release the handles. Rotate the clip-on tool
clockwise to extend the helix. To remove the clip-on tool, pinch it together and withdraw it from the lead
connector.
NOTE: The stylet should be removed before testing the lead for mechanical stability or making
intraoperative measurements.

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Figure 5. Opening the clip-on tool
1. Insert lead into notch

Figure 6. Extending the helix by rotating the clip-on tool clockwise

Securing the Tip with the Helix Locking Tool

As an alternative to the clip‑on tool, the Helix Locking Tool may be used to extend or retract the helix.
1. Check the Use‑By date on the packaging. Do not use tool if the Use‑By date has passed.
2. Aseptically remove tool from packaging.
Do not use tool if:
– Dropped from packaging
– Sterility is breached
3. Slide Helix Locking Tool onto the connector end of lead. The tool should be fully inserted as shown in
illustration.
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Figure 7. Helix Locking Tool Fully Inserted
1. Fully inserted to connector pin

4. After the fixation site has been selected, hold the lead body stationary in one hand and turn the Helix
Locking Tool in the direction of the arrow marked “EXTEND HELIX” (clockwise).
NOTE: See Technical Specifications (page 16) for the approximate number of turns required. On the
fluoroscopic image, the helix will be extended beyond the marker ring.
5. PSA cables may be attached in the zones depicted below.

Figure 8. PSA Cable Attachment Zones

1. Attachment Zones

6. If necessary, retract the helix by holding the lead body stationary in one hand and turning the Helix
Locking Tool in the direction marked “RETRACT HELIX” (counterclockwise).

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Figure 9. Helix Locking Tool retraction

7. After completion, slide tool backward to remove.

Left Bundle Branch Area Pacing [LBBAP] Lead Placement

LBBAP Lead Implant Preparation
NOTE: Use a multi-lead ECG or a pacing system analyzer to facilitate accurate lead placement and obtain
recommended electrical measurements.
NOTE: Backup pacing should be readily available during implant. Transient AV block, RBBB, or permanent
RBBB can occur from lead implantation in the LBB area.
NOTE: It is recommended to use the Helix locking tool (HLT) for left bundle branch area lead implant.
NOTE: It is recommended to use a stylet to help prevent mechanical damage to the lead during
implantation.
1. Place the delivery catheter within the right ventricle using the instructions provided with the delivery
system.
2. Insert the lead into the delivery catheter.
3. Advance the lead to the tip of the catheter.
4. Slide the Helix locking tool (HLT) onto the pin connector of the lead. See Securing the Tip with the Helix
Locking Tool (page 9).

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Figure 10. LBBAP lead placement

Localizing the Lead Insertion Site (Mapping)

NOTE: Mapping the His bundle, contrast injection, or unipolar pacing may assist in identifying the lead
insertion site.
NOTE: Mapping can be conducted either with the helix extended or with the helix retracted.
1. Manipulate the catheter to position the lead at the target lead insertion site on the right ventricular
septum.
2. If desired, PSA cables can be connected to the lead via HLT or stylet.

Implanting the Lead in the LBBA

1. Once the lead insertion site is identified, orient the delivery catheter with the lead inside as close to a
relatively perpendicular orientation to the septum as possible. Maintain the catheter orientation and
position throughout the following steps.
2. If PSA cables are connected to the lead via HLT, disconnect the PSA cables. If desired, PSA cables can be
relocated to the stylet.
NOTE: By connecting the PSA cables to the stylet, unipolar impedance may be monitored
continuously throughout the implant procedure. Hydration of the lead may help to stabilize electrical
connections while monitoring.
3. Hold the lead body stationary in one hand and extend the helix into the septal tissue by turning the HLT
clockwise (in the direction of the arrow marked “EXTEND HELIX”) See Technical Specifications for the
approximate number of turns required (page 16).
4. Once helix is extended into the septal tissue, perform an additional 5 rotations on the HLT to preload
torque onto the helix.
5. While maintaining the catheter orientation and position, rotate the lead body clockwise and apply a
light forward pressure to the lead body to burrow into the septal wall.

WARNING: Excessive torque and/or tip pressure may cause acute trauma to the endocardium and/or
septum, including possible perforation, which may result in temporarily high or low impedance, or high
capture threshold values. Monitor torque transfer, as it may vary from patient to patient.

CAUTION: During implant procedure, if septal perforation is observed, stop rotating the lead body and
follow the next section Acute removal or repositioning of the Lead (page 13).
CAUTION: Without the HLT, the helix will inadvertently be retracted when the lead body is rotated
clockwise. Check for helix retraction periodically on fluoroscopy and when an increase in impedance is
observed.
CAUTION: If torque is not transferring effectively as the lead body is being rotated, do not continue to
rotate the lead body. Further rotations can result in damage to the helix or make it difficult to remove.
Reposition the catheter and reattempt burrowing.

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 NOTE: It is also important to minimize the friction within the catheter by keeping it free of too many
kinks, turns, sticky contrast etc. This is important to allow torque to be transmitted properly.

6. Assess the lead placement in the septum using preferred techniques.

7. Perform electrical measurements.

Acute Removal or Repositioning of the Lead

WARNING: During implant procedure, removal of the lead after fixation may result in damage to the
cardiovascular tissue and/or damage to the helix.
CAUTION: Do not attempt to implant the same lead more than 3 times.
1. Recreate the angle and advancement of the catheter present at the time of initial helix deployment
(relative to the lead helix and endocardium).
NOTE: Do not attempt to retract the helix while the lead is still in the septal wall.
2. If the helix appears intact, rotate the lead body counterclockwise while holding the delivery catheter in
place to withdraw the lead from the implant site.
3. Remove the lead from the venous access while leaving the delivery catheter in place. Once outside the
body, inspect the lead and helix to ensure integrity. Clean any tissues or fascia attached to the helix (as
necessary). Helix functionality may be assessed by extending and retracting the helix using the HLT.
4. Once satisfied with the lead and helix integrity, insert the lead with a retracted helix back into the
catheter and repeat the LBBAP implant procedure starting at the LBBAP Lead Implant Preparation
(page 11) section at a different location than the previous attempt.
NOTE: Ensure the location of the second implant attempt is not at the same spot as the first attempt
in case of septal perforation. Lead entry into the same site during reimplantation could be
determined by fluoroscopic landmarks, absent fixation beats, similar paced QRS morphology, and/or
hyper transmission of rotations to the lead tip inside the septal wall.

Intraoperative Measurements
NOTE: The stylet should be removed before testing the lead for mechanical stability or making final
intraoperative measurements.
It is important to verify stimulation threshold and sensing capability during implantation. A pacing system
analyzer (PSA) is recommended for these electrical measurements.
A low threshold value and high intracardiac signals are signs that the lead has been positioned satisfactorily.
WARNING: A pacing lead inserted into the heart presents a direct, low-impedance pathway for current
flow to the myocardium. Use only battery-powered test equipment for electrical measurements.

Connection to the Pacing System Analyzer

▪ Remove the stylet from the lead once the lead is in what is believed to be a suitable location.
▪ Exercise caution when applying alligator clips to the lead’s connector pin to avoid damaging the
insulation between terminals.
For more information on the use of the PSA, please refer to the PSA manual.

Recommended Values
If the initial measurements are different from those in the Recommended values table (page 13), it is best to
wait a while and then repeat the measurements. If the values do not stabilize at an acceptable level it may
be necessary to alter the position of the electrode tip.
Table 4. Recommended values measured with a PSA
Atrium Ventricle1
Acute Stimulation Threshold ≤1.5 V ≤1.0 V
at default pulse width

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 Table 4. Recommended values measured with a PSA
Atrium Ventricle1
Acute Sensing Amplitude ≥2 mV ≥5 mV
Bipolar Pacing Impedance 250-2000 Ω 250-2000 Ω
1
includes LBBAP

Removing the Delivery Catheter from the Lead

Once the lead is in the final position and the electrical parameters are satisfactory, complete the following
steps to remove the delivery catheter:
1. Disconnect PSA cables from the lead or stylet.
2. Partially withdraw the stylet (i.e., ~10 cm) to avoid lead dislodgement during slitting.
3. Remove the HLT from the lead.
4. Flush the delivery catheter.
5. Under fluoroscopy, pull back the delivery catheter while gently advancing the lead to provide adequate
lead slack prior to slitting.
6. Slit and remove the delivery catheter from the lead. For further instructions on slitting and removing
the delivery catheter, see the delivery system product documentation.
7. Repeat electrical measurements.
WARNING: Do not reimplant the lead if the lead is dislodged during slitting.

Securing the Lead

Once the lead has achieved a stable position with good thresholds, ensure the lead has adequate slack and
securely anchor the lead at or near the venous entry site using a nonabsorbable synthetic suture. First
secure the suture sleeve to the underlying tissue, then recheck lead position visually and under fluoroscopy
(to prevent twisting of the lead and identify inadvertent retraction or advancement of the lead).
Tie sutures firmly around each available groove on the suture sleeve. The most distal groove may be used to
tie off the vein over the suture sleeve.
Figure 11. Suturing the lead

1. Vein
2. Fascia
3. Lead body
4. Suture sleeve

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 CAUTION:
▪ If an accessory suture sleeve is used, it should be used as a replacement to the existing suture
sleeve on the lead and should not be used in conjunction with the existing suture sleeve. The use
of multiple suture sleeves to secure the lead is not recommended as it may result in damage to the
lead.
▪ Use the suture sleeve to distribute the tension created by the suture. Failure to use the suture
sleeve may result in damage to the lead’s insulation or conductor coil.
▪ If removal of the suture sleeve is necessary, use caution when sliding over the electrode rings as
lead damage can occur.
▪ Suture sleeve sticking can occur. If this occurs, carefully twist the sleeve off the ring toward the
connector pin; pulling the suture sleeve when it is positioned over the electrode ring may cause a
tear in the lead body near the electrode ring.
▪ Do not tie the suture around the suture sleeve and lead too tightly, as this may result in excessive
stress applied to the lead body.
If an accessory suture sleeve is used:
1. Carefully open the slit in the sleeve and position the sleeve on the lead body.
2. Follow the procedure above to suture and secure the sleeve.

Connection to the Device

Once the lead is anchored, connect the lead to the device following the instructions in the device manual.
Grasp the lead connector as close as possible to the connector pin while inserting the lead connector
straight into the device port. If necessary, regrip the lead and continue to insert the lead connector until it is
fully seated in the device port.
CAUTION: Orient the excess lead length and the device to minimize the potential for insulation damage
resulting from lead-to-lead or device-to-lead interaction. For example, minimize the potential for leads
lying on top of each other under the device and ensure that there are no sharp bends in the lead. Lead
insulation damage can create an alternate electrical current path which may result in compromised
therapy delivery. Current practice indicates that a subcutaneous pocket is preferred over a subpectoral
pocket. 1
NOTE: For LBBAP lead implant, it is recommended to record the lead implant location (LBBAP) in the
Implant Notes on the Merlin Programmer.

Patient Registration Form

Fill out and return the Patient Registration Form to register the patient and facilitate patient tracking.

Patient Identification Card

NOTE: If implanting a device and leads at the same time, fill out the Patient Identification Card included
with the device. See Patient Implant and Identification Cards in the device manual.
For implanting only Abbott Medical leads without an accompanying Abbott Medical device
1. Fill out the Patient Identification Card as provided in the outer box with:
▪ Patient's name
▪ Implant date
▪ Your name or healthcare facility information along with the contact phone number
2. Record leads information or apply the labels provided with the sterile package, in the designated
section of the card:
▪ Model number
▪ Serial number

1
Furman S, Hayes DL, Holmes DR: A Practice of Cardiac Pacing. 3rd ed. New York: Futura Publishing, Inc.; 1993:286-289.
Belott, PH, Reynolds, DW. Permanent Pacemaker and Implantable Cardioverter-Defibrillator Implantation. In: Ellenbogen
KA, Kay GN, Wilkoff BL, eds. Clinical Cardiac Pacing and Defibrillation. 2nd ed. Philadelphia, PA: WB Saunders;
1995:613-615.
15
 ▪ UDI number
3. Fill out the corresponding fields on the Patient Identification Card:
▪ Lead Model & Length
▪ Implant Location of the lead (e.g., RA, RV, LBBAP)
Patient Follow-up
Give the completed card to the patient. This will serve as a temporary card until Abbott Medical mails a
permanent card directly to the patient. To obtain a replacement card if a patient loses or damages their
card, contact Abbott Medical Technical Support (page 16).

Lead Extraction
CAUTION:
▪ Lead extraction carries with it clinical risk. If a pacing lead must be removed due to infection or
other serious reason, great care should be exercised.
▪ A pacing lead explanted for any reason should never be implanted in another patient.
If the lead or any portion of it is extracted, return it to the manufacturer.
It is generally recommended that a chronically implanted endocardial pacing lead not be repositioned
except in special circumstances.

Explantation
After use, this product may be a potential biohazard. If the lead or any portion of it is extracted, handle it
according to local regulations. Clean the explanted device with disinfectant and return it to Abbott Medical
for investigation and safe disposal. For safety reasons, it is recommended that all used leads be enclosed in a
protective cover.
Please complete an Out of Service/Explant/Patient Death form and return it to Abbott Medical with the
explanted device. Whenever possible, send along a printout of the programmed settings of the pulse
generator.

Technical Support
Abbott Medical maintains 24‑hour phone lines for technical questions and support:
▪ 1 818 362 6822
▪ 1 800 722 3774 (toll-free within North America)
▪ + 46 8 474 4147 (Sweden)
▪ + 61 2 9936 1200 (Australia)
▪ medical.abbott/manuals
For additional assistance, call your local Abbott Medical representative.
Any serious incident should be reported to Abbott Medical and the FDA.

Technical Specifications

Table 5. Nominal Specifications

Length 46, 52, 58, 65, 100 cm
Connector type IS-1 2bipolar
Lead introducer (minimum 6F 3 (without retained guidewire)
recommended)

2
Abbott Medical IS‑1 lead connectors are compatible with connector cavities that conform to the international connector
standard ISO 5841‑3.
3
Compatible with introducers such as those manufactured by Daig and Pressure Products.
16
 Table 5. Nominal Specifications
Maximum diameter of lead 1.9 mm
body
Fixation mechanism active helix
Electrode configuration
Tip helix
Ring cylindrical
Electrode spacing
Tip to ring 10 mm
Electrode surface area
Tip 7.0 mm2
Ring 15.3 mm2
Electrode length
Tip (extended) 2 mm
Electrical resistance
Tip to connector pin 46 cm: 14-24Ω; 52 cm: 16-28Ω; 58 cm: 19-31Ω;
65 cm: 21-35Ω; 100 cm: 35-57Ω
Ring to connector ring 46 cm: 29-49Ω; 52 cm: 33-55Ω; 58 cm: 37-61Ω;
65 cm: 42-68Ω; 100 cm: 63-105Ω

Materials
Conductors multifilar MP35NLT
Connectors stainless steel
Lead body insulation Optim™ 4 insulation with exterior Fast-Pass™ coating
Suture sleeve silicone rubber
Tip and ring electrodes titanium nitride-coated platinum iridium alloy
Soft tip silicone rubber
Steroid-eluting plug silicone rubber with 460 micrograms of dexamethasone sodium phosphate
(DSP)
Stylet stainless steel
Lead cap silicone rubber

Typical number of rotations to

extend helix for initial
placement 5
Straight stylet 6-11 6
J stylet 9-14 7
LBBAP 8-18 8

4
Optim is a silicone-polyurethane copolymer.
5
Lead length, stylet configuration, and differences in anatomy may cause variations in the number of rotations required
to extend the helix.
6
Not to exceed 35 rotations.
7
Not to exceed 35 rotations.
8
Not to exceed 35 rotations.
17
Stylet Color Codes
Table 6. Stylet color codes
Knob Color Description Diameter
Green Soft straight (20 mm taper) 0.014 in./0.35 mm
Light green Extra-soft straight (40 mm taper) 0.014 in./0.35 mm
Yellow Firm straight 0.015 in./0.38 mm
Red Extra firm straight 0.016 in./0.41 mm
Green, white dot Soft (20 mm taper) 0.014 in./0.35 mm

Symbols
The symbols below and harmonized symbols may be found on the product or product label. For
harmonized symbols, refer to the Universal Symbols Glossary at medical.abbott/manuals.
Symbol Description
Accessories

Product literature

Product of USA

Product of Malaysia

Unique Device Identifier

Follow instructions for use on this website

Patient identification card label

Patient identification

Date

Healthcare center or physician

Physician telephone

Lead model/length

Location of implant

18
Symbol Description
Double sterile barrier

Pacing lead

Prescription use only

MR Conditional

Contains hazardous substances

19
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