Boston Scientific ENDOTAK RELIANCE User manual

PHYSICIAN’S LEAD MANUAL
ENDOTAK RELIANCE®
Steroid-Eluting Tined Endocardial
Defibrillation Leads
0147/0148
0128
ENDOTAK RELIANCE®S
RESTRICTED DEVICE:
Federal law (USA) restricts the sale, distri-
bution, or use of this device to, by or on
the lawful order of a physician.

13
2
8
5
4
7
6
ENDOTAK RELIANCE S Leads Model 0128 ENDOTAK RELIANCE Leads Models 0147/0148
1. Distal steroid-eluting pace/sense electrode (cathode) 2. Proximal pace/sense coil electrode (anode), distal defi-
brillating coil electrode
3. Proximal defibrillating coil electrode–
ENDOTAK RELIANCE only
4. Suture Sleeve
5. Yoke 6. Distal defibrillating electrode terminal (cathode) 7. Pace/sense electrode terminal 8. Proximal defibrillating electrode terminal (anode)
12
4
6
5
7

Table of Contents
INFORMATION FOR USE.................................................. 1
Device Description........................................................ 1
Indications .................................................................... 1
Contraindications .......................................................... 1
Warnings ...................................................................... 1
AICD/Lead Compatibility .......................................... 2
MRI Exposure........................................................... 2
Diathermy Exposure................................................. 2
Implanting................................................................. 2
Electrical Performance ............................................. 3
Conversion Testing .................................................. 3
Securing and Tunneling ........................................... 3
Single Use Only........................................................ 3
Precautions................................................................... 3
General..................................................................... 3
Adverse Events ............................................................ 4
Observed Adverse Events........................................ 4
Potential Adverse Events ......................................... 5
Clinical Trial .................................................................. 6
Clinical Investigation................................................. 7
Warranty ..................................................................... 10
DEVICE FEATURES ......................................................... 11
Detailed Device Description........................................ 11
LEAD EVALUATION......................................................... 13
Implant Information..................................................... 13
Included Items ............................................................ 13
Opening Instructions................................................... 14
Sterilization ................................................................. 14
Surgical Preparation ................................................... 14
Accessory Options...................................................... 14
Suture Sleeves ....................................................... 15
Stylets..................................................................... 15
Stylet Guide............................................................ 15
Vein Pick ................................................................ 15
Lead Caps .............................................................. 16
Handling the Lead ...................................................... 16
IMPLANTATION................................................................ 17
Inserting the Stylet ...................................................... 17
Inserting the Lead....................................................... 17
Positioning the Lead ................................................... 20
Minimizing Pacemaker Interaction.............................. 21

Checking for Lead Stability......................................... 22
Evaluating Lead Position............................................ 22
Taking Baseline Measurements............................. 22
Electrical Performance ............................................... 23
Evaluating with the Pulse Generator...................... 24
Evaluating with the PRM ........................................ 24
Conversion Testing .................................................... 24
Securing the Lead ...................................................... 26
Percutaneous Implant Technique ......................... 26
Venous Cut-Down Technique ................................ 26
Tunneling the Lead to the Abdominal Pocket ........ 28
Connection to a Pulse Generator ............................... 29
POST-IMPLANT EVALUATION....................................... 30
Follow-Up Testing ...................................................... 30
Explantation................................................................ 30
REFERENCES .................................................................. 31
SPECIFICATIONS (Nominal) .......................................... 32
SYMBOLS ON PACKAGING........................................... 33

INFORMATION FOR USE 1
INFORMATION FOR USE
Device Description
The ENDOTAK®RELIANCETM lead, Models 0147/0148, and
the ENDOTAK® RELIANCETM S lead, Model 0128, are
steroid-eluting, tined, endocardial cardioversion/defibrillation
and pace/sense leads. The ENDOTAK RELIANCE lead (dual
coil) and the ENDOTAK RELIANCE S lead (single coil) are for
use as an integral part of an AICD automatic implantable
cardioverter defibrillator system with DF-11and IS-12ports.
The lead features a small active surface area of the distal tip
electrode that is designed to increase pacing impedance.
Instructions in this manual should be used in conjunction with
other resource material including the applicable AICD device
system manual and instructions for use on any implant
accessories or tools.
This literature is intended for use by professionals trained or
experienced in device implant and/or follow-up procedures.
Indications
The ENDOTAK RELIANCE lead, Models 0147/0148, and the
ENDOTAK RELIANCE S lead, Model 0128, provide pacing
and rate-sensing and deliver cardioversion and defibrillation
shocks for AICD automatic implantable cardioverter
defibrillator systems.
Contraindications
Use of the ENDOTAK RELIANCE or ENDOTAK RELIANCE S
lead is contraindicated for the following patients:
• Patients who have a unipolar pacemaker
• Patients with a hypersensitivity to a maximum single dose
of 1.1 mg of dexamethasone acetate
• Patients with mechanical tricuspid heart valves
Warnings
In the following list of warnings, page numbers are indicated
for those warnings that are specific to other areas of the
manual. Refer to the indicated pages for information relevant
to the warning.

INFORMATION FOR USE
2
AICD/Lead Compatibility
• Do not attempt to use the ENDOTAK lead system with any
device other than a commercially available implantable
defibrillator system with which it has been tested and dem-
onstrated to be safe and effective. The potential adverse
consequences of using a combination that has not been
tested and demonstrated to be safe and effective may
include, but are not limited to, undersensing cardiac activity
and failure to deliver necessary therapy.
MRI Exposure
• Do not expose a patient to the MRI environment. Strong
electromagnetic fields in the MRI environment may
interfere with the pulse generator and lead system and
cause injury to the patient.
Diathermy Exposure
• Do not expose a patient to diathermy treatment. Shortwave
or microwave diathermy may cause injury to the patient.
Implanting
• Lead fracture, dislodgment, abrasion and/or an incomplete
connection can cause a periodic or continual loss of
rate-sensing, possibly resulting in arrhythmia nondetection;
or over-sensing of rate, possibly resulting in inappropriate
delivery of a pulse generator shock; or inadequate delivery
of conversion energy.
• Although pliable, the lead body is not designed to tolerate
excessive flexing, bending, or tension. This could cause
structural weaknesses, conductor discontinuity, and/or lead
dislodgment. (Page 16)
• Take care to obtain appropriate electrode position. Failure
to do so may result in higher defibrillation thresholds or
may render the lead unable to defibrillate a patient whose
tachyarrhythmia(s) might otherwise be convertible by an
AICD system. (Page 21)
• In order to deliver defibrillation therapy, the single-coil
ENDOTAK RELIANCE S lead must be implanted with a
separate defibrillation electrode. Boston Scientific recom-
mends using the ENDOTAK RELIANCE S lead with a pec-
torally implanted device that uses the metallic housing as a
defibrillation electrode. (Page 21)

INFORMATION FOR USE 3
Electrical Performance
• When connecting the lead to the AICD pulse generator, it is
very important that proper connections are made. Damage
to the heart could result if a high-voltage defibrillating pulse
were to be delivered through the pace/sense porous tip
electrode. (Page 23)
Conversion Testing
• Use of any component of the ENDOTAK lead system to
assist in delivery of external-source rescue shocks could
cause extensive tissue damage. (Page 25)
Securing and Tunneling
• Do not kink, twist, or braid the lead terminals as doing so
could cause lead insulation abrasion damage. (Page 28)
Single Use Only
• For single patient use only. Do not reuse, reprocess, or
resterilize. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/or
lead to device failure which, in turn, may result in patient
injury, illness, or death. Reuse, reprocessing, or
resterilization may also create a risk of contamination of the
device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of
the device may lead to injury, illness, or death of the
patient.
Precautions
General
• It has not been determined whether the warnings, precau-
tions, or complications usually associated with injectable
dexamethasone acetate apply to the use of the low con-
centration, highly localized, controlled-release device. For
a listing of potentially adverse effects, refer to the Physi-
cians’ Desk Reference™.1
• Refer to the Implant Information, Implantation, and
Post-Implant Evaluation sections of this manual for cau-
tions specific to handling, implanting, and testing the
ENDOTAK RELIANCE lead family. Failure to observe
1. Physicians' Desk Reference is a trademark of Thomson Healthcare, Inc.

INFORMATION FOR USE
4
these cautions could result in incorrect lead implantation,
lead damage, and/or harm to the patient.
• This lead contains 0.87 mg dexamethasone acetate. Store
at 25° C (77° F). Excursions permitted between 15°-30°C
(59°-86° F). Transportation spikes permitted up to 50° C
(122° F).
Adverse Events
Given the similar design features, including the porous tip
electrode, steroid performance, and high pacing impedance,
the ENDOTAK ENDURANCE Rx clinical investigation was
used to support the ENDOTAK RELIANCE or ENDOTAK
RELIANCE S lead. The following are the adverse events
reported in that investigational study.
A total of two complications and six observations related to
the implanted device or system components were reported
during the clinical investigation of the ENDOTAK
ENDURANCE Rx lead. One hundred and one patients were
enrolled in the investigation, and ninety-eight were implanted
with 478.6 cumulative implant months.
Observed Adverse Events
Table 1 reports lead or system related complications and
observations for the ENDOTAK ENDURANCE Rx lead.

INFORMATION FOR USE 5
Potential Adverse Events
Based on the literature and lead implant experience, the
possible physical effects from implantation of an ENDOTAK
Table 1. ENDOTAK ENDURANCE Rx lead Study Complications
and Observations
# of
pts
(n = 98)
% of
pts
(95% Cl)
# of
leads
(n = 98)
# of
AEsa
a. AE = Adverse Event is defined as the total (lead related) complica-
tions and observations.
Complications b
(all types)
b. Complications are defined as adverse events requiring invasive mea-
sures to correct (eg, surgical intervention).
22.0%
(0.0–4.8%) 22
Hematoma 11.0%
(0.0–3.0%) 11
Noncapture (connector) 11.0%
(0.0–3.0%) 11
Observationsc
(Type I)
c. Observations are defined as adverse events which are correctable by
non-invasive measures (eg, reprogramming); Type 1 observations
are related to the implanted device or a system component.
66.0%
(1.3–10.7%) 66
Oversensing 22.0%
(0.0–4.8%) 22
Threshold difficulty 22.0%
(0.0–4.8%) 22
Telemetry 11.0%
(0.0–3.0%) 11
Inappropriate therapy 11.0%
(0.0–3.0%) 11

INFORMATION FOR USE
6
RELIANCE or ENDOTAK RELIANCE S lead are listed below
in alphabetical order:
Clinical Trial
Given the similar design features, including the porous tip
electrode, steroid performance, and high pacing impedance,
the ENDOTAK ENDURANCE Rx clinical investigation was
•Airembolism
• Allergic reaction
• Arterial damage with
subsequent stenosis
• Bleeding
• Breakage/failure of the
implant instruments
• Cardiac perforation/
tamponade
• Chronic nerve damage
• Component failures
• Conductor coil fracture
• Death
• Electrolyte imbalance/
dehydration
• Erosion/extrusion
• Excessive fibrotic tissue
growth
• Extracardiac stimulation
(muscle/nerve stimulation)
• Fluid accumulation
• Foreign body rejection
phenomena
• Formation of hematomas or
cysts
• Heart block
• Hemorrhage
• Hemothorax
• Inability to provide therapy
• Inappropriate therapy/shocks
• Incisional pain
• Incomplete connection with
pulse generator
• Infection
• Keloid formation
• Lead abrasion
• Lead displacement/
dislodgment
• Lead fracture, insulation
break
• Lead tip deformation and/or
breakage
• Local tissue reaction
• Low amplitude VF signals
• Malignancy or skin burn due
to fluoroscopic radiation
• Myocardial injury
• Myocardial irritability
• Myopotential sensing
• Oversensing/undersensing
• Pericardial rub, effusion
• Pneumothorax
• Post-shock rhythm
disturbances
• Pulse generator and/or lead
migration
• Shunting of current or
insulation of myocardium
during defibrillation with
internal or external paddles
• Tachyarrhythmias, which
include acceleration of
arrhythmias and early,
recurrent atrial fibrillation
• Threshold elevation
• Thrombosis/thromboemboli
• Valve damage
• Venous occlusion
• Venous perforation/erosion

INFORMATION FOR USE 7
used to support the ENDOTAK RELIANCE or ENDOTAK
RELIANCE S lead. The following is a summary of findings
from the ENDOTAK ENDURANCE Rx Lead Clinical
Investigation.
In clinical application, dexamethasone sodium phosphate is
functionally equivalent to dexamethasone acetate. The
dexamethasone sodium phosphate steroid plug was used in
the clinical study.
Clinical Investigation
The study was a non-randomized historical control study
comparing the performance of the ENDOTAK ENDURANCE
Rx lead to that of the ENDOTAK DSP lead. The objectives of
this investigation were to demonstrate higher pacing
impedance and lower pacing threshold performance of the
ENDOTAK ENDURANCE Rx lead compared to the historical
control lead, the ENDOTAK DSP. Ninety-eight patients were
implanted with the ENDOTAK ENDURANCE Rx lead. The
mean implant duration of the study population was 4.9 months
with a cumulative implant duration of 478.6 months. No
statistical differences were found in the baseline variables
between the study patient group and the historical control
group with respect to demographic profiles except for age,
primary arrhythmia and antiarrhythmic drug therapy. None of
these factors are clinically significant relative to meeting the
study endpoints. Additional demographic information is
presented in Table 2.
Table 2. Description of the Study Population (n = 98)
Characteristic
ENDOTAK
ENDURANCE Rx
Lead Population
ENDOTAK DSP
Lead
Population
Number of Patients 98 78
Gender
Male
Female
78
20
60
18
Age at Implant (years)
Range
Mean + Standard Deviation
29.8–84.7
66 + 11.4
33–75
60.9 + 9.7
Mean LVEF + Standard Deviation (%) 34.3 + 13.4 35.1 + 14.1

INFORMATION FOR USE
8
Lead measurements were recorded at implant, predischarge,
1 month, and 3 month follow-up visits. The results in Table 3
and Table 4 show a statistically significant difference in
impedance and threshold values when comparing the
ENDOTAK ENDURANCE Rx lead and the control lead.
The mean ENDOTAK ENDURANCE Rx lead impedance was
69.1% higher at implant and 31.6% higher at 3 months than
the control lead. Subsequently, the mean ENDOTAK
ENDURANCE Rx lead impedance is 67% above the nominal
industry standard of 500 Ω at 3 months. Figure 1 shows a
graphical comparison of ENDOTAK ENDURANCE Rx lead,
Primary Arrhythmia
MVT
VF
PVT
Other
68
17
8
5
38
27
5
8
Primary Cardiac Disease
Coronary artery disease
Cardiomyopathy
Other
62
25
11
42
26
10
Table 3. Lead Pacing Impedance by Follow-up Period (n = 98)
Follow-
up
ENDOTAK
ENDURANCE Rx ENDOTAK DSP Statistical
Analysis %
Change
Mean
(Ω)SD N Mean SD N t-
test P-Value
Implant 906.0 180.8 96 535.7 111.7 77 15.7 0.0001a
a. Extremely statistically significant (p ≤0.001).
69.1
Predis-
charge 815.5 142.5 95 520.0 86.3 67 15.1 0.0001a56.8
1
month 830.1 118.7 88 604.2 111.5 58 11.5 0.0001a37.4
3
months 836.5 130.7 79 635.5 90.1 26 7.3 0.0001a31.6
Table 2. Description of the Study Population (n = 98)

INFORMATION FOR USE 9
the control lead, and the nominal industry standard in terms of
lead impedance.
Pacing thresholds measured at implant, predischarge, 1 month
and 3 month follow-up visits were compared to the historical
control to demonstrate lower pacing threshold performance.
Study results in Table 4 show that the ENDOTAK
ENDURANCE Rx lead pacing threshold was 37.1% lower at
implant and 42.9% lower at 3 months when compared to the
control lead representing a statistically significant reduction in
pacing thresholds throughout the chronic implant period.
Note: The data in Table 4 was obtained using clinical leads
that contained an average dose of 0.4 mg dexamethasone
sodium phosphate, which is less than the approximate dose
used in the commercially available design.
R-wave amplitudes were also measured at implant and were
compared to the implant R-wave amplitudes for the historical
control to determine equivalency of sensing characteristics.
Results demonstrate that the ENDOTAK ENDURANCE Rx
lead’s R-wave amplitudes are equivalent to those for the
ENDOTAK DSP lead.
ENDOTAK ENDURANCE
Control (ENDOTAK DSP)
Industry Standard
Implant 1 Month 3 Months
Time
Impedance Ω
Figure 1. ENDOTAK ENDURANCE Rx lead impedance by
follow-up period. (n=98)

INFORMATION FOR USE
10
There was no statistical difference in the number of patient
deaths between the ENDOTAK ENDURANCE Rx lead and
the control lead. There were two complications in the
ENDOTAK ENDURANCE Rx lead study with one due to a
header connector issue that was resolved by tightening the
set screws, and the second due to a hematoma. One
complication was documented in the historical control group
during a three month duration that was due to infection. An
actuarial analysis on the complications demonstrates no
significant difference between the ENDOTAK ENDURANCE
Rx lead and the Control lead with the p-value = 0.69.
ENDOTAK ENDURANCE Rx lead’s higher impedance values
and low pacing thresholds may combine to reduce pacing
system energy requirements—potentially improving pacing
system longevity. For specific pacing system longevity values,
refer to the applicable pulse generator physician’s manual.
Warranty
A limited warranty certificate for the lead is available For a
copy, please contact Boston Scientific Corporation using the
information on the back cover.
Refer to the Contraindications, Warnings, Precautions, and
Adverse Events sections of this manual for information
concerning the performance of this device.
Table 4. Mean Pacing Threshold (V) at 5.0 ms by Follow-Up
Period (n=98)
Follow-
up
ENDOTAK
ENDURANCE Rx ENDOTAK DSP Statistical
Analysis %
Change
Mean
(Volts) SD N Mean SD N t-test P-Value
Implant 0.66 0.60 95 1.05 0.81 77 –3.63 0.0004a
a. Extremely statistically significant (p ≤ 0.001).
–37.1
Predis-
charge 0.63 0.29 95 1.27 1.08 67 –5.51 0.0001a–50.4
1
month 0.76 0.48 88 1.52 0.93 58 –6.48 0.0001a–50.0
3
months 0.88 0.74 79 1.54 0.77 25 –3.85 0.0002a–42.9

DEVICE FEATURES 11
DEVICE FEATURES
Detailed Device Description
Features of the ENDOTAK RELIANCE or ENDOTAK
RELIANCE S lead include the following components:
•Porous Tip Electrode: The porous tip electrode serves as
the cathode for intracardiac right ventricular electrogram
rate-sensing and pacing. The lead uses a platinum-iridium
porous tip electrode design that increases the effective
active area for sensing by allowing fibrotic tissue ingrowth
and an increase in chronic lead tip stability while maintain-
ing a small surface area for pacing.
•Steroid: The tip electrode contains dexamethasone ace-
tate contained in a silicone rubber binder. Upon exposure
to body fluids, the steroid elutes from the electrode. Steroid
suppresses the inflammatory response believed to cause
threshold rises typically associated with implanted pacing
electrodes. Lower thresholds are desirable because they
can increase pacing safety margins and reduce pacing
energy requirements.
•High Pacing Impedance: The lead features a small active
surface area of the distal tip electrode that is designed to
increase pacing impedance. The lead’s high impedance
performance and low pacing thresholds may combine to
reduce pacing system energy requirements—potentially
increasing the pacing longevity of the pulse generator.
•Coil Electrodes: The distal coil Electrode is intended to
serve as an anode for rate-sensing and pacing and as a
cathode or anode for cardioversion/defibrillation shocks.
The proximal coil Electrode on the ENDOTAK RELIANCE
lead is intended to serve as an anode or cathode for
cardioversion/defibrillation shocks. The ENDOTAK RELI-
ANCE S lead uses the implanted device’s metallic housing
as a defibrillation electrode.
•Lead Body: The isodiametric lead body contains one con-
ductor for pacing/sensing. The ENDOTAK RELIANCE lead
has two conductors for defibrillation and the ENDOTAK
RELIANCE S lead has one conductor for defibrillation. The
conductors are coated with PTFE and insulated in separate
lumens within the silicone rubber lead body. A second layer
of silicone coats the lead body providing additional insula-
tion and uniform body diameter. Fixation tines, a terminal

DEVICE FEATURES
12
yoke, suture sleeves, and terminal moldings are fabricated
from molded silicone rubber. The entire lead body fits
through a 9 Fr lead introducer when not retaining a guide
wire. A color-coded mark on the terminal end of the lead
allows for a quick visual reference of the lead length. The
lead color matches the same length stylet cap color.
•Lubricious Coating: The ENDOTAK RELIANCE lead fam-
ily is the first to introduce a proprietary coating that makes
the silicone lead surface more lubricious. The coating
reduces both the static and dynamic coefficients of friction,
making the lead surface feel and handle like polyurethane
while providing the time-tested reliability of silicone.
•Terminals: The ENDOTAK RELIANCE lead has three ter-
minals: two DF-1 (shock), and one IS-1 bipolar (pace/
sense). The ENDOTAK RELIANCE S lead has one DF-1
(shock) terminal and one IS-1 terminal (pace/sense).The
pace/sense terminal is tubular and is fitted with a stylet
guide to facilitate the insertion of a stylet.
The lead is intended for chronic implantation within the
superior vena cava, right atrium, and right ventricle. When
connected to the AICD pulse generator, the implanted lead
will perform the following functions:
• Provide rate-sensing and shocking electrode electrograms
• Deliver cardioverting/defibrillating electrical shocks from
the pulse generator to the heart
• Provide pacing capabilities if available in the AICD pulse
generator
Nominal overall lengths of the leads are as follows:
The electrode spacing (measured from the distal tip to distal
end of the proximal coil Electrode) of the ENDOTAK
RELIANCE lead is 18 cm (Figure 2).
ENDOTAK RELIANCE 0147 0148
59 cm 64 cm
ENDOTAK RELIANCE S 0128
64 cm

LEAD EVALUATION 13
LEAD EVALUATION
Implant Information
Proper surgical procedures and techniques are the
responsibility of the medical professional. The described
implant procedures are furnished for informational purposes
only. Each physician must apply the information in these
instructions according to professional medical training and
experience.
A major consideration in choosing the ENDOTAK RELIANCE
lead family is that it does not require a thoracotomy. The
physician should weigh its advantages against the patient’s
ability to withstand additional electrophysiology (EP) testing
(arrhythmia induction and conversion testing), and a possible
thoracotomy should the lead system prove ineffective.
Various factors, such as cardiomegaly or drug therapy, may
necessitate repositioning of the defibrillating leads or
substitution of one lead system for another in order to facilitate
arrhythmia conversion. In some cases, reliable arrhythmia
conversion may not be obtained with any leads at the
available AICD energy levels.
Bipolar pacemakers may be used with the ENDOTAK
RELIANCE lead family and AICD pulse generator as long as
the pacemaker and AICD pulse generator do not interact,
causing AICD pulse generator nondetection or false detection
(see “Minimizing Pacemaker Interaction” on page 21).
The lead is not designed, sold, or intended for use except as
indicated.
Included Items
The following items are packaged with the ENDOTAK
RELIANCE or ENDOTAK RELIANCE S lead:
Figure 2. Electrode spacing for the ENDOTAK RELIANCE lead is
measured from the distal tip to the distal end of the proximal coil
Electrode.
• Lead caps (2) DF-1 and (1) IS-1
18 cm

LEAD EVALUATION
14
Opening Instructions
The outer package and inner sterile
tray may be opened by authorized
personnel under clean conditions. To
ensure sterility, the sealed inner
sterile tray must be opened using
accepted aseptic technique by
scrubbed, masked, sterile-gowned
personnel. The sterile tray is opened
by peeling back the cover.
Sterilization
Boston Scientific sterilizes the lead and accessories with
ethylene oxide gas (EtO) before final packaging. When they
are received, they are sterile and ready for use. If the
container is wet, damaged, punctured, or if the seal is broken,
return the lead to the nearest Boston Scientific representative.
Never attempt to resterilize the lead.
Surgical Preparation
Instrumentation for cardiac monitoring, imaging (fluoroscopy),
defibrillation, and lead signal measurements must be
available during implant. When using electrical
instrumentation, electrically isolate the patient from potentially
hazardous current leakage. Boston Scientific also
recommends availability of sterile duplicates of all implantable
items in case of accidental damage or contamination.
Accessory Options
The following items are packaged with the lead and are also
available from Boston Scientific as accessory items:
• Vein pick
• Stylet guide
• Soft stylets (0.014-in/0.36-mm diameter)
• Firm stylets (0.016-in/0.41-mm diameter)
• Literature packet
• DF-1 port plugs (ENDOTAK RELIANCE S lead
only)

LEAD EVALUATION 15
Suture Sleeves
Suture sleeves are an
adjustable, tubular
reinforcement positioned over
the outer lead insulation (Figure
3). They are designed to secure
and protect the lead at the venous entry site after distal
electrode fixation. Using suture sleeves optimizes lead
longevity and reduces the possibility of structural damage
caused by suturing directly over the lead body.
To move a suture sleeve, gently twist and pull it over the lead
until it is in the desired position.
CAUTION: Do not suture directly over the lead body as this
may cause structural damage. Use the suture sleeves to
secure the lead lateral to the venous entry site.
Stylets
Stylets of varying stiffness are packaged with each lead.
Stylets are also available as accessory items. A stylet inserted
in the lead aids in positioning the lead tip in the heart. The
stylet length is imprinted on the color-coded cap of the knob
(Table 5). Also refer to “Inserting the Stylet” (Page 17) for
more information.
Stylet Guide
A stylet guide is packaged with the lead and is intended to
ease insertion of a stylet into the pace/sense terminal of the
lead (Figure 4).
Vein Pick
The vein pick is a sterile, disposable, nontoxic, nonpyrogenic,
plastic device designed to assist the physician during entry of
the lead’s electrode tip into the vein.
Table 5. Stylets
Stylet Length (cm) Knob Color Cap Color
Straight
59 Green=Soft
or
White=Firm
Yellow
64 Green
90 Orange
Figure 3. The long tapered
end of the suture sleeve
faces toward the vein.
Figure 4. Using the stylet guide.