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Protego Steroid Eluting ICD Leads
Technical Manual
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the order of,
a physician.
© 2014 BIOTRONIK, Inc., all rights reserved.
Table of Contents
Protego Steroid Eluting ICD Leads Technical Manual
Contents
1. General................................................................................................................................................ 1
1.1 Description..................................................................................................................................... 1
1.2 Indications for Use......................................................................................................................... 1
1.3 Contraindications........................................................................................................................... 1
1.4 Protego Lead Names..................................................................................................................... 2
1.5 Warnings........................................................................................................................................ 2
1.6 Precautions.................................................................................................................................... 3
1.6.1 Sterilization, Storage, and Handling����������������������������������������������������������������������������������������� 3
1.6.2 Implantation and Evaluation����������������������������������������������������������������������������������������������������� 3
1.6.3 Pulse Generator Explant and Disposal������������������������������������������������������������������������������������� 4
1.6.4 Hospital and Medical Hazards�������������������������������������������������������������������������������������������������� 5
1.7 Adverse Events.............................................................................................................................. 6
1.7.1 Potential Adverse Events���������������������������������������������������������������������������������������������������������� 6
1.7.2 Observed Adverse Events�������������������������������������������������������������������������������������������������������� 6
1.8 Clinical Studies............................................................................................................................... 7
1.8.1 Protego ICD Leads.................................................................................................................... 7
1.8.2 Kentrox SL‑S Steroid and Kentrox RV‑S Steroid���������������������������������������������������������������������� 7
2. Sterilization and Storage..................................................................................................................11
3. Implant Procedure............................................................................................................................ 13
3.1 Implant Preparation...................................................................................................................... 13
3.2 Product Inspection....................................................................................................................... 13
3.3 Opening the Sterile Container����������������������������������������������������������������������������������������������������� 14
3.4 Protego T and Protego TD Lead Insertion���������������������������������������������������������������������������������� 14
3.5 Active Fixation Lead Insertion����������������������������������������������������������������������������������������������������� 15
3.5.1 Checking the Function of the Fixation Helix before Implantation
16
3.5.2 Accessing the Vein and Inserting the Lead����������������������������������������������������������������������������� 16
3.6 Intraoperative Measurements����������������������������������������������������������������������������������������������������� 19
3.7 PA10 DF4 Adapter....................................................................................................................... 20
3.7.1 Technical description............................................................................................................... 20
3.8 Anchoring the Lead...................................................................................................................... 21
3.9 Connecting the Lead to the Device��������������������������������������������������������������������������������������������� 22
3.10 Final Implant Steps and Defibrillation Testing��������������������������������������������������������������������������� 24
3.11 Testing the Complete Device System���������������������������������������������������������������������������������������� 24
4. Follow-Up Procedures...................................................................................................................... 27
4.1 ICD Patient Follow-Up.................................................................................................................. 27
4.2 Explantation................................................................................................................................. 27
5. Package Contents............................................................................................................................ 29
6. Technical Data (Protego Passive Fixation Leads)������������������������������������������������������������������������ 31
7. Technical Data (Protego Active Fixation Leads)��������������������������������������������������������������������������� 35
8. Disclaimer......................................................................................................................................... 38
PAGE i
Table of Contents
Protego Steroid Eluting ICD Leads Technical Manual
PAGE ii
Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
1. General
1.1 Description
The Protego ICD lead is a steroid-eluting lead for use with any ICD with a DF4 connector port according
to ISO 27186.
The Protego S and Protego T Leads have two pace/sense electrodes (distal tip and ventricular ring
electrode) and one defibrillation electrode (ventricular shock coil). The Protego SD and Protego TD
Leads have two pace/sense electrodes (distal tip and ventricular ring electrode) and two defibrillation
electrodes (ventricular and superior vena cava shock coils
These leads, in conjunction with a compatible ICD, perform the following functions:
• sense electrical signals from cardiac tissue and conduct those signals to the ICD;
• conduct bradycardia and antitachycardia pacing pulses emitted from the ICD to cardiac tissue;
• conduct cardioversion/defibrillation shocks of both high and low energies from the ICD to cardiac
tissue.
The Protego Leads are intended for placement in the right ventricle. The tip and ring electrodes form
the most distal portion of the lead and provide dedicated bipolar sensing and pacing.
All Protego Leads have one shock electrode that is positioned in the right ventricle (RV). The Protego
SD and Protego TD dual-coil ICD leads have an additional shock electrode for placement in the
superior vena cava (SVC). All Protego leads feature Silglide® surface treatment, designed to reduce
the force required to maneuver the lead during the implant procedure.
The Protego S and Protego SD leads feature an electrically active extendable/ retractable fixation
helix for use in lead placement. The helix is extended and retracted by rotating the connector pin with
a fixation tool. Both the fixation helix and ring electrode are comprised of a platinum/iridium alloy base
with fractal iridium. The Protego T and Protego TD leads feature a passive fixation tip coated with
fractal iridium.
The fractal surface structure on the electrode provides a larger effective tissue interface that is a major
factor in determining a lead’s sensing characteristics.
All Protego ICD leads include a steroid eluting collar at the distal end (tip electrode), which elutes
dexamethasone acetate (DXA) to the surrounding tissue after implantation. Release of the steroid
is intended to decrease the inflammatory response at the contact site between the lead tip and the
endocardium, thereby decreasing the elevated pacing thresholds of the endocardial lead that often
occur after lead implantation.
Each Protego lead has a quadripolar DF4 connector according to ISO 27186:2010-03, which connects
to the shock coils as well as to the tip and ring electrodes for bipolar sensing and pacing.
1.2 Indications for Use
The Protego 8F steroid-eluting, bipolar, IS-1 transvenous lead system is intended for use in the right
ventricle of patients for whom implantable cardioverter defibrillators are indicated.
1.3 Contraindications
Do not use the Protego Lead System in patients with severe tricuspid valve disease or patients who
have a mechanical tricuspid valve implanted.
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Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
Active Fixation
The Protego steroid-eluting leads with active fixation are additionally contraindicated for patients who
cannot tolerate a single systemic dose of up to 1.3 mg of dexamethasone acetate (DXA).
Passive Fixation
The Protego steroid-eluting leads with passive fixation are additionally contraindicated for patients who
cannot tolerate a single systemic dose of up to 1.0 mg of dexamethasone acetate (DXA).
1.4 Protego Lead Names
The Protego lead names include both the lead type and the overall length of the lead in centimeters.
The letter "T" designates passive fixation (tined) and "S" designates active fixation (helix). The suffix
"D" denotes leads with dual shock coils. The number following the letter designation indicates the
overall length of the lead in centimeters (60, 65 or 75 cm). For dual coil leads, the number after the
slash denotes the distance in centimeters between the SVC shock coil and the lead tip. Thus, the name
"Protego TD 65/16" refers to a Protego passive fixation, dual coil lead, with a total length of 65 cm and
a distance of 16 cm between the SVC shock coil and the lead tip.
1.5 Warnings
Adapter Inspection—Always visually check the adapter prior to usage. Do not use wet or damaged
adapters. Wet or damaged adapters may result in malfunction of the adapter and pose a risk to
the patient.
Advancing the Lead—Use of excessive force with a preformed stylet can result in a significant level of
pressure being placed on the ventricular myocardium via the lead tip.
Defibrillation Threshold—Be aware that changes in the patient’s condition, drug regimen, and other
factors may affect the defibrillation threshold (DFT) which may result in nonconversion of the arrhythmia
post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during
arrhythmia conversion testing is no assurance that conversion will occur post‑operatively.
Electric Shock—Do not touch the adapter during defibrillation. Touching the adapter during
defibrillation may endanger people involved in the procedure.
Fixation Tool Rotation—Only rotate the fixation tool as many times as necessary for complete helix
extension. Always verify the position of the fixation helix using fluoroscopy. The myocardium can be
damaged if the fixation helix is over-rotated.
Helix Extension—Do not operate the helix mechanism if it has become sticky due to coagulated blood
or bodily fluid or if it has been substantially overwound during retraction or extension. The lead may be
too damaged for use.
Leakage Currents—Only connect implanted leads to battery-operated measurement and pacing
devices or to devices that are classified as type CF (Cardiac Floating) applied parts complying with IEC
60601. Always follow the instructions in the respective technical manuals. All other line-powered devices
connected to the patient must be properly grounded. Leakage currents can trigger ventricular fibrillation.
MRI (Magnetic Resonance Imaging)—Do not expose a patient to MRI device scanning. Strong
magnetic fields may damage the device and cause injury to the patient.
Resuscitation Availability—Do not perform induction testing unless an alternate source of patient
defibrillation such as an external defibrillator is readily available.
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Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
1.6 Precautions
Always observe the technical manuals and accompanying documents for devices combined with this
lead (ICD, additional leads) and for devices and implant accessories used during implantation.
1.6.1 Sterilization, Storage, and Handling
Lead Packaging—Do not use the lead if the lead’s packaging is wet, punctured, opened or damaged
because the integrity of the sterile packaging may be compromised. Return the lead to BIOTRONIK.
Resterilization—These leads are intended for single use. Do not resterilize and re-implant explanted
leads.
Storage (temperature)—Storage at temperatures up to 25° C (77° F); excursions permitted from
5° to 55° C (41° to 131° F). Exposure to temperatures outside this range may result in lead malfunction.
Use Before Date—Do not implant the lead after the USE BEFORE DATE.
1.6.2 Implantation and Evaluation
Adapter Modification­—Never modify the adapter. Modifications to the adapter may result in loss of
function and thereby pose a risk to the patient.
Allergic Reaction—Prevent the adapter from contacting the skin or wounds, since in extremely rare
cases the adapter material may trigger allergic reactions.
Anchor Site—Consider the following when determining where to anchor the lead at the entry site:
• Contraction of the heart and other movement of the patient should not put tension on the fixated lead.
• The tricuspid valve's function must not be hindered by the lead.
Anchoring Sleeve—Always use an anchoring sleeve (lead fixation sleeve) when implanting a
lead. Use of the anchoring sleeve, which is provided with the lead, will lessen the possibility of lead
dislodgment and protect the lead body from damage by a securing ligature.
Blind Plugs—Always close unused ports with blind plugs. Open IS-1 or DF-1 ports can cause
undesired current flows to the body. Bodily fluid can penetrate into the device and damage it.
Blood Ingress—Coagulated blood can affect the maneuverability of the stylet in the lead and inhibit or
block the screw mechanism.
• Ensure that no blood reaches the interior of the lead on, or with, the stylet
• As far as possible, prevent blood from entering the lead from other pathways
Capping Leads—If a lead is abandoned rather than removed, it must be capped to ensure that it is not
a pathway for currents to or from the heart.
Cross-Threading—To prevent cross-threading the set screw, do not back the set screw completely out
of the threaded hole. Leave the screwdriver in the slot of the set screw while the lead is inserted.
DFT Testing—For leads with a DF4 connector, the intraoperative DFT test cannot be performed using
patient cables. For this purpose, the lead needs to be connected directly to an ICD (see "Testing the
complete device system").
Gripping Leads—Do not grip the lead with surgical instruments or use excessive force or surgical
instruments to insert a stylet into a lead.
Helix Mechanical Function Test—Do not implant the lead if this function test is not successful. In this
case, test a replacement lead in the same way, and if the test is successful, implant the replacement lead.
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Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
Lead Accessories—Please take the following precautions into account to prevent damage to the lead:
• Only use the lead with a stylet inserted, even if you only want to check the helix mechanism.
• The stylet must not be kinked or overbent.
• Only use the provided fixation tool, which is clamped to the connector pin, to extend and retract the
fixation helix. Do not use any other tools or accessories.
Lead Handling—Make sure that the lead is neither knotted, twisted, nor bent at a sharp angle. This
could cause damage to the conductors or result in abrasion of the lead’s insulation.
Lead Positioning—If the ICD is implanted underneath the pectoral muscle, ensure that no parts of the
lead lie between the ribs and clavicle or between the housing of the ICD and the ribs/clavicle. Chafing
and pressure on the lead between the housing of the ICD and the ribs/clavicle could damage the lead’s
insulation and thus cause premature failure.
o prevent mechanical overstress from causing the failure of pacing/sensing functions, make sure that
T
the lead does not become pinched between the clavicle and the first rib after implantation.
Liquid Immersion—Do not immerse leads in mineral oil, silicone oil, or any other liquid.
Over-Tightening—Do not over-tighten the set screw(s). Use only a torque wrench which automatically
prevents over-tightening.
PA10 DF4 Adapter—Only connect a DF4 connector with an intraoperative test system using a
BIOTRONIK PA10 DF4 adapter. Do not contact DF4 connectors directly with alligator clips, or the
connector may be damaged.
Pacing Interruption—During intracardiac measurements, pacing will be temporarily interrupted.
Repositioning or Explanting—Before repositioning or explanting the lead, use fluoroscopy to ensure
that the fixation helix has been fully retracted.
Sealing System—Failure to properly insert the torque wrench into the perforation at an angle
perpendicular to the connector receptacle may result in damage to the sealing system and its selfsealing properties.
Set screw(s)—Failure to back off the set screw(s) may result in damage to the lead(s), and/or difficulty
connecting the lead(s).
Shock Impedance—Never implant a device with a lead system that has a measured shock impedance
that is less than what is recommended in the appropriate ICD technical manual. Damage to the device
may result. If the shock impedance is less than the recommended value, reposition the lead system to
allow a greater distance between the electrodes.
Short Circuit—Ensure that none of the lead electrodes are in contact (a short circuit) during delivery of
shock therapy as this may cause current to bypass the heart or cause damage to the ICD system.
Suitable Stylets—Use only the stylet supplied with the respective lead (based on length and diameter).
Never use extremely curved or bent stylets. The use of unsuitable stylets or improper handling of the
stylet can result in damage to the lead.
Tricuspid Valve Bioprosthesis—Use ventricular transvenous leads with caution in patients with a
tricuspid valvular bioprosthesis.
1.6.3 Pulse Generator Explant and Disposal
Device Incineration—Never incinerate an ICD due to the potential for explosion. An ICD must be
explanted prior to cremation.
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Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
Explanted Devices—Return all explanted devices to BIOTRONIK.
Unwanted Shocks—Prior to explanting the ICD, program the detection status of the device to OFF to
prevent unwanted shocks.
1.6.4 Hospital and Medical Hazards
Diathermy—Diathermy therapy is not recommended for ICD patients due to possible heating effects at
the implant site. If diathermy therapy must be used, it should not be applied in the immediate vicinity of
the pulse generator or lead system. Following the procedure, proper ICD function should be checked
and monitored.
Electrocautery—Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may
cause device malfunction or damage. If use of electrocautery is necessary, the current path and ground
plate should be kept as far away from the pulse generator and leads as possible.
Excessive Pressure—Excessive pressure and hyperbaric oxygen therapy should be avoided, as it
may cause damage to the implant.
External Defibrillation—External defibrillation may result in permanent myocardial damage at the
electrode-tissue interface as well as temporarily or permanently elevated pacing thresholds. When
possible, observe the following precautions:
• Position the adhesive electrodes or defibrillation paddles of the external defibrillator
anterior‑posterior or along a line perpendicular to the axis formed by the implanted ICD system and
the heart.
• Set the energy to a level not higher than is required to achieve defibrillation.
• Place the paddles as far as possible away from the implanted device and lead system.
• After delivery of an external defibrillation shock, interrogate the ICD to confirm device status and
proper function.
Lithotripsy—Lithotripsy treatment should be avoided since electrical and/or mechanical interference
with the ICD is possible. If this procedure must be used, the greatest possible distance from the point of
electrical and mechanical strain should be chosen in order to minimize a potential interference with the
implant.
Medical Procedures—For any medical procedures that may affect the device (e.g., therapeutic
ultrasound, external defibrillation, electrophysiological ablation, HF surgery, lithotripsy), perform a
complete follow-up after the procedure.
MRI (Magnetic Resonance Imaging)—Do not expose a patient to MRI device scanning. Strong
magnetic fields may damage the device and cause injury to the patient.
Radio Frequency Ablation—Prior to performing an ablation procedure, deactivate the ICD. Avoid
applying ablation energy near the implanted lead system whenever possible. The ICD system should
be checked for proper operation after the procedure.
Therapeutic Ultrasound—Therapeutic ultrasound is not recommended due to the possible heating
effects of the device at the implant site. If therapeutic ultrasound must be considered, it should not be
applied in the immediate vicinity of the implant.
Transcutaneous Electrical Nerve Stimulation (TENS)—Transcutaneous Electrical Nerve Stimulation
must be avoided, as it may lead to unintended heart stimulation.
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Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
1.7 Adverse Events
1.7.1 Potential Adverse Events
Adverse events (in alphabetical order) associated with ICD systems include, but are not limited to:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Acceleration of arrhythmias
Air embolism
Arrhythmias
Bleeding
Cardiac tamponade
Chronic nerve damage
Device migration
Elevated pacing thresholds
Erosion
Fluid accumulation
Foreign body rejection phenomena
Formation of hematomas, cysts or
fibrotic tissue
Heart valve damage
Inappropriate shocks
Infection
Keloid formation
Lead abrasion and discontinuity
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Lead migration/dislodgment
Lead fracture/insulation damage
Muscle or nerve stimulation
Myocardial damage
Myopotential sensing
Pacemaker mediated tachycardia
Pneumothorax
Potential mortality due to inability to
defibrillate or pace
Shunting current or insulating
myocardium during defibrillation with
internal or external paddles
Thromboembolism
Undersensing of intrinsic signals
Valvular damage
Venous occlusion
Venous or cardiac perforation
Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop
psychological intolerance to an ICD system that may include the following:
• Dependency
• Depression
• Fear of premature battery depletion
• Fear of shocking while awake
• Fear that shocking ability may be lost
• Imagined shocking (phantom shock)
1.7.2 Observed Adverse Events
Since the Protego ICD leads are based on BIOTRONIK’s legally marketed Kentrox SL Steroid ICD lead,
the observed adverse events for this predecessor have been included in this section of the manual.
1.7.2.1 Kentrox
The Kentrox RV‑S Steroid and Kentrox SL‑S Steroid ICD leads clinical evaluation included a total of 64
patients implanted with 43 Kentrox RV‑S Steroid leads and 21 Kentrox SL‑S Steroid leads. All adverse
events are classified into two types: observations and complications. Observations are defined as
clinical events that do not require additional invasive intervention to resolve. Complications are defined
as clinical events that require additional invasive intervention to resolve.
NOTE:
The Kentrox RV‑S Steroid and Kentrox SL‑S Steroid ICD leads are earlier generation of BIOTRONIK
devices. The Protego family is based upon the Kentrox family and other BIOTRONIK ICD Leads
(i.e., Linox and Kainox families of ICD leads).
PAGE 6
Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
Table 1 provides a summary of the observed complications with the steroid version of the Kentrox ICD
leads. Of the 64 patients, 35 were followed for at least 3 months and only 1 (1.6%) patient underwent a
lead revision due to elevated pacing thresholds/loss of ventricular capture in this steroid lead registry.
Table 1: Kentrox RV‑S Steroid and Kentrox SL‑S Steroid Lead Related Complication Rate
Complication
Number of
Patients with
Complications
Percentage of
Patients with
Complications
Number of
Complications
Steroid (Total Number of Patients = 64, Followed for 3 months = 35)
Elevated Ventricular Pacing Threshold
1
1.6%
1
Lead Repositioning
1
1.6%
1
Total Steroid
2
3.2%
2
1.8 Clinical Studies
1.8.1 Protego ICD Leads
Since the Protego ICD leads are based on BIOTRONIK’s legally marketed Linoxsmart, Linox and
Kentrox SL Steroid ICD leads, engineering tests and an animal study were performed in lieu of human
clinical data.
1.8.2 Kentrox SL‑S Steroid and Kentrox RV‑S Steroid
BIOTRONIK conducted a prospective registry outside the United States (OUS) of the Kentrox RV‑S
Steroid and Kentrox SL‑S Steroid ICD leads. Because no reasonable non-steroid control data from
leads with the exact physical specifications was available, no comparison analysis was performed.
However, data from this registry is presented in the following sections simply to support the efficacy of
the Kentrox RV‑S and Kentrox SL‑S Steroid ICD leads including pacing threshold measurements that
are within the normal range for steroid leads.
1.8.2.1 Patients Studied
The Kentrox RV‑S and Kentrox SL‑S Steroid ICD leads clinical evaluation included a total of 64 patients
implanted with 43 Kentrox RV‑S Steroid leads and 21 Kentrox SL‑S Steroid leads. The study population
had a mean age of 65 years (range: 54 to 76 years) and included 59 males (92%) and 5 females (8%).
Patients presented with ventricular fibrillation (52%–VF) and ventricular tachycardia (48%–VT). One
month follow-up data for 49 patients and three month follow-up data for 35 patients was received and
reviewed for this summary.
1.8.2.2 Methods
Investigators were required to use the implanted ICD to obtain ventricular lead measurements including
intrinsic sensing amplitudes, pacing thresholds and lead impedance values at the implant, predischarge, one-month, three-month, and subsequent routine follow-ups.
PAGE 7
Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
1.8.2.3 Results
Table 2, Table 3 and Table 4 provide summaries of measured ventricular pacing thresholds, R-waves,
and ventricular pacing impedance measurements, respectively. Additionally, Table 2 depicts the
ventricular pacing thresholds over time. Both the Kentrox RV‑S Steroid and the Kentrox SL‑S Steroid
ICD leads were pooled for presentation of this data because the leads are identical except for the
second high energy shock coil embedded in the Kentrox SL‑S Steroid ICD lead.
Sixty-one tests with two successful 20 J shocks or less demonstrated the ICD lead system’s ability to
convert VF and provide a minimum 10 J safety margin with BIOTRONIK ICDs.
Table 2: Ventricular Pacing Threshold
Pacing Threshold (Volts @ 0.5ms)
Results
Implant
Number of Tests
64
Mean ± SE
0.5 ± 0.1
Range
0.3 to 1.2
Pre-discharge Follow-up
Number of Tests
59
Mean ± SE
0.8 ± 0.1
Range
0.3 to 4.6
One-Month Follow-up
Number of Tests
49
Mean ± SE
1.1 ± 0.2
Range
0.3 to 5.2
Three-Month Follow-up
Number of Tests
PAGE 8
35
Mean ± SE
0.9 ± 0.2
Range
0.3 to 4.6
Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
Figure 1: Ventricular Pacing Threshold
Table 3: R-Wave Amplitude
R-Wave (mV)
Results
Implant
Number of Tests
63
Mean ± SE
12.0 ± 0.4
Range
5.2 to 17.6
Pre-discharge Follow-up
Number of Tests
58
Mean ± SE
11.5 ± 0.4
Range
4.1 to 17.5
One-Month Follow-up
Number of Tests
49
Mean ± SE
11.7 ± 0.5
Range
6.3 to 17.3
Three-Month Follow-up
Number of Tests
35
Mean ± SE
11.7 ± 0.5
Range
6.1 to 17.1
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Chapter 1 General
Protego Steroid Eluting ICD Leads Technical Manual
Table 4: Ventricular Pacing Impedance
Pacing Impedance (Ohms)
Results
Implant
Number of Tests
Mean ± SE
Range
42
573 ± 19
400 to 1126
Pre-discharge Follow-up
Number of Tests
Mean ± SE
Range
40
468 ± 12
339 to 871
One-Month Follow-up
Number of Tests
Mean ± SE
Range
34
507 ± 13
377 to 829
Three-Month Follow-up
Number of Tests
Mean ± SE
Range
24
525 ± 23
354 to 989
1.8.2.4 Discussion and Conclusion
There were a total of 64 patients implanted with 21 Kentrox SL‑S Steroid leads and 43 Kentrox RV‑S
Steroid leads.
• Two of the 64 patients (3.125%) experienced lead related complications; patient #17 experienced
an increase in pacing threshold and had an additional pace/sense lead added; patient #18
experienced a lead repositioning, an expected risk occurrence when using ICD leads, which was
successfully revised.
• Sixty-one tests with two successful 20 J shocks or less demonstrated the ICD lead system’s ability
to convert VF and provide a minimum 10 J safety margin with BIOTRONIK ICDs.
• All pacing thresholds, R-wave amplitudes and pacing impedances are within clinically-acceptable
normal ranges for single-coil and dual-coil, dedicated bipolar, ICD leads.
The data received and analyzed demonstrate that the Kentrox SL‑S Steroid and Kentrox RV‑S Steroid
ICD leads are safe and effective for the implanted patients.
PAGE 10
Chapter 2 Sterilization and Storage
Protego Steroid Eluting ICD Leads Technical Manual
2. Sterilization and Storage
This lead is shipped in packaging equipped with a quality control seal and product information label.
The label contains the model specifications, technical data, serial number, expiration date, sterilization,
and storage information. The lead and its accessories have been sealed in a container and gas
sterilized with ethylene oxide.
PAGE 11
Chapter 2 Sterilization and Storage
Protego Steroid Eluting ICD Leads Technical Manual
PAGE 12
Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
3. Implant Procedure
Always observe the technical manuals and accompanying documents for devices combined with this
lead (ICD, additional leads) and for devices and implant accessories used during implantation.
3.1 Implant Preparation
Prior to beginning an implant of the Protego Lead System, ensure that all of the necessary equipment
is available. The implant procedure requires the ICD, the lead system, a programmer, other external
testing equipment, and the appropriate cabling and accessories. Additional sterile equipment and
devices should be available in the event of accidental contamination or damage.
CAUTION
Capping Leads—If a lead is abandoned rather than removed, it must be
capped to ensure that it is not a pathway for currents to or from the heart.
Gripping Leads—Do not grip the lead with surgical instruments or use
excessive force or surgical instruments to insert a stylet into a lead.
Liquid Immersion—Do not immerse leads in mineral oil, silicone oil, or any
other liquid.
Short Circuit—Ensure that none of the lead electrodes are in contact (a
short circuit) during delivery of shock therapy as this may cause current to
bypass the heart or cause damage to the ICD system.
Tricuspid Valve Bioprosthesis—Use ventricular transvenous leads with
caution in patients with a tricuspid valvular bioprosthesis.
3.2 Product Inspection
The lead and its accessories are packaged in a double blister and sterilized with ethylene oxide. To
assure sterility, inspect the packaging and check for integrity prior to opening. Do not use products if
the lead or packaging appears damaged. Should a breach of sterility be suspected, return the lead to
BIOTRONIK.
CAUTION
Lead Packaging—Do not use the lead if the lead’s packaging is wet,
punctured, opened or damaged because the integrity of the sterile
packaging may be compromised. Return the lead to BIOTRONIK.
Storage (temperature)—Storage at temperatures up to 25° C (77° F);
excursions permitted from 5° to 55° C (41° to 131° F). Exposure to
temperatures outside this range may result in lead malfunction.
Use Before Date—Do not implant the lead after the USE BEFORE DATE.
Should a replacement lead be required, contact your local BIOTRONIK representative.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
3.3 Opening the Sterile Container
1. In a non-sterile area, open the outer blister by peeling the paper seal in the direction of the arrow.
2. In the sterile area, remove the inner, sterile blister by using the gripping the tab. Open the inner
blister by peeling the paper seal in the direction of the arrow.
3.4 Protego T and Protego TD Lead Insertion
The following procedure is recommended for implanting the Protego T and Protego TD leads.
1. Prior to lead placement, inspect the lead to ensure that the fixation sleeve is positioned close to
the junction near the connector portion of the lead.
2. Venous access may be obtained through a standard cut-down or introducer technique. If the
introducer method is used, select an appropriate introducer for the lead. A vein lifter is supplied
inside the sterile packaging for use, if needed. If using the cephalic cutdown procedure for lead
implant, carefully insert the pointed end of the disposable vein lifter into the lumen after opening
the vein, and then lift the vein to permit easy lead insertion (see the following figure).
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
NOTE:
The recommended introducer size for the Protego T and Protego TD leads is 8 French.
3. The lead should be inserted into the vein and advanced into the ventricle under fluoroscopic
guidance. Four stylets are included in the sterile package. Additional stylets are available in
separate packaging, if required. Do not shape the stylet while it is inserted in the lead body.
When changing stylets, care should be taken to keep the stylet free of blood to help ensure easy
insertion and removal.
4. Advance the lead into the right ventricle. The tip should be placed in the apex of the right
ventricle. Ensure the lead tip is stable within the ventricle and is in contact with the endocardium.
Once adequate lead placement is achieved, the stylet should be carefully withdrawn under
fluoroscopy so as not to dislodge the lead.
3.5 Active Fixation Lead Insertion
CAUTION
Suitable Stylets—Use only the stylet supplied with the respective lead
(based on length and diameter).
Never use extremely curved or bent stylets.
The use of unsuitable stylets or improper handling of the stylet can result in
damage to the lead.
CAUTION
Helix Mechanical Function Test—Do not implant the lead if this function
test is not successful. In this case, test a replacement lead in the same way,
and if the test is successful, implant the replacement lead.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
3.5.1 Checking the Function of the Fixation Helix before Implantation
Use the included fixation tool to extend the fixation helix (turn right, clockwise) and retract it (turn left,
counterclockwise). When fully extended, the fixation helix protrudes a maximum of 1.8 mm from the
lead body. It typically takes 6 to 10 complete rotations to completely extend the fixation helix, however it
can take up to 20 rotations.
Prior to implantation, test the operation of the fixation helix with inserted stylet.
CAUTION
Lead Accessories—Please take the following precautions into account to
prevent damage to the lead:
• Only use the lead with a stylet inserted, even if you only want to check
the helix mechanism.
• The stylet must not be kinked or overbent.
• Only use the provided fixation tool, which is clamped to the connector
pin, to extend and retract the fixation helix. Do not use any other tools
or accessories.
1. Remove the stylet guide from the lead connector. This leaves it on the part of the stylet that is
protruding from the lead. The stylet remains entirely in the lead.
2. Clamp one of the included fixation tools to the connector pin of the lead connector.
3. Turn the fixation tool in clockwise direction until the fixation helix is fully extended.
4. Turn the fixation tool in counterclockwise direction until the fixation helix is fully retracted.
5. Remove the fixation tool from the connector pin and place the stylet guide back on the lead
connector.
6. Do not implant the lead if it fails the function test. Instead, use a replacement lead that has
passed the same test.
3.5.2 Accessing the Vein and Inserting the Lead
1.
2.
3.
4.
Ensure that the fixation helix is completely retracted.
Position the premounted lead fixation sleeve close to the lead connector.
Ensure that a straight stylet is completely inserted into the lead.
If the subclavian stick approach is used to gain venous access, select an appropriate introducer
for the lead.
CAUTION
Suitable Stylets—Use only a suitable stylet for the respective lead (based
on length and diameter).
Never use extremely curved or bent stylets
The use of unsuitable stylets or improper handling of the stylet can result in
damage to the lead
PAGE 16
Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
CAUTION
Helix Mechanical Function Test—Do not implant the lead if this function
test is not successful. In this case, test a replacement lead in the same way,
and if the test is successful, implant the replacement lead.
NOTE:
The recommended introducer size for the Protego S and Protego SD leads is 8 French.
5. If using the cephalic cutdown approach, open the vein, carefully insert the tip of the provided vein
lifter into the lumen of the vein, carefully lift the vein and insert the lead into the opening. See
Figure 2.
Figure 2: Vein Lifter
NOTE:
Suitable spare stylets are included in sterile packaging with the lead. They can also be ordered
individually as accessories.
CAUTION
Lead Positioning—Make sure the lead does not become pinched between
the clavicle and the first rib after implantation.
Securing the Lead Tip
Remove the stylet guide from the lead connector. It is now on the end of the stylet that is protruding
from the lead. The stylet remains entirely in the lead.
Clamp one of the included fixation tools onto the contact pin of the lead connector.
Secure the lead tip in the myocardium by keeping the lead in position while rotating the fixation tool
clockwise until the helix is fully extended.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
6. Advance the lead into the right ventricle under fluoroscopic guidance.
WARNING
Advancing the Lead—Use of excessive force with a preformed stylet
can result in a significant level of pressure being placed on the ventricular
myocardium via the lead tip.
7. Use fluoroscopy to verify the position of the fixation helix. Both the helix and the tip are visible
under fluoroscopy as noted in the X-rays below.
Figure 3: Helix Retracted
Figure 4: Helix Extended
CAUTION
Repositioning or Explanting—Before repositioning or explanting the lead,
use fluoroscopy to ensure that the fixation helix has been fully retracted.
8. If, due to repeated extension and retraction of the fixation helix (from repositioning of the lead
tip), the helix mechanism becomes difficult to handle or if it sticks, the lead should be removed
and replaced with a new one by following these measures:
• No longer use the helix mechanism.
• Rotate the entire lead with inserted stylet counterclockwise in order to unhelix the lead from
the myocardium without using the helix mechanism.
WARNING
Fixation Tool Rotation—Only rotate the fixation tool as many times as
necessary for complete helix extension.
Always verify the position of the fixation helix using fluoroscopy.
The myocardium can be damaged if the fixation helix is over-rotated.
PAGE 18
Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
WARNING
Helix Extension—Do not operate the helix mechanism if it has become
sticky due to coagulated blood or bodily fluid or if it has been substantially
overwound during retraction or extension.The lead may be too damaged
for use.
3.6 Intraoperative Measurements
Standard baseline lead measurements should be performed before connecting the lead to a
BIOTRONIK ICD. Medical judgment should be used in cases where optimal lead signals cannot be
reliably obtained.
If tunneling is required, baseline R-wave and capture threshold measurements are recommended
after the tunneling procedure to confirm lead performance and ensure system integrity. Refer to the
appropriate BIOTRONIK ICD manual for the configuration of the ports prior to connecting the leads.
NOTE:
A suitable patient cable has to be used for temporary connection of the lead to an intraoperative test
system. The stylet must be removed prior to the measurement.
CAUTION
PA10 DF4 Adapter—Only connect a DF4 connector with an intraoperative
test system using a BIOTRONIK PA10 DF4 adapter. Do not contact DF4
connectors directly with alligator clips, or the connector may be damaged.
WARNING
Leakage Currents—Only connect implanted leads to battery-operated
measurement and pacing devices or to devices that are classified as type
CF (Cardiac Floating) applied parts complying with IEC 60601. Always
follow the instructions in the respective technical manuals.
All other line-powered devices connected to the patient must be properly
grounded.
Leakage currents can trigger ventricular fibrillation.
CAUTION
Pacing Interruption—During intracardiac measurements, pacing will be
temporarily interrupted.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
CAUTION
DFT Testing—For leads with a DF4 connector, the intraoperative DFT
test cannot be performed using patient cables. For this purpose, the lead
needs to be connected directly to an ICD (see "Testing the complete
device system").
3.7 PA10 DF4 Adapter
3.7.1 Technical description
1
2
3
1. Drawer for the connector
2. Slide switch
3. Contact surfaces for alligator clips
WARNING
Electric Shock—Do not touch the adapter during defibrillation
Touching the adapter during defibrillation may endanger people involved in
the procedure.
WARNING
Adapter Inspection—Always visually check the adapter prior to usage. Do
not use wet or damaged adapters. Wet or damaged adapters may result in
malfunction of the adapter and pose a risk to the patient.
CAUTION
Allergic Reaction—Prevent the adapter from contacting the skin or
wounds, since in extremely rare cases the adapter material may trigger
allergic reactions.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
CAUTION
Adapter Modification—Never modify the adapter. Modifications to the
adapter may result in loss of function and thereby pose a risk to the patient.
Instructions for Use
1. Hold the adapter between thumb and index finger. Press the slide switch down slightly and push
it forward at the same time. The drawer for the connector will open.
2. Place the DF4 connector of the lead into the drawer for the connector from above. Make sure
that the connector is inserted until it stops.
3. Close the drawer for the connector until it snaps in place with an audible click.
4. Verify that the lead is properly seated by ensuring that the blue tip of the lead is visible.
5. Connect the alligator clips to the contact surfaces:
• Contact surface + (for 1st ring)
• Contact surface - (for connector pin of the DF4 connector)
6. Hold the alligator clips by the protective sleeves, otherwise there is a direct electrical connection
to the myocardium.
7. Perform all required measurements. To reposition a lead with active fixation, you need to remove
the patient adapter but not the alligator clips.
8. Remove the patient adapter by opening the drawer for the connector. Press the slide switch
down slightly and forward at the same time.
9. Pull the DF4 connector upwards to remove it from the drawer for the connector.
3.8 Anchoring the Lead
Fixating the lead at the entry site in the vein or in the muscle minimizes the risk of dislodgment. The
lead comes with a lead fixation sleeve which has ligature grooves and ligature tabs. The lead fixation
sleeve enables secure and smooth fixation of the lead at its entry site and decreases the risk of
damaging the insulation or coil during fixation.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
CAUTION
Anchor Site—Consider the following when determining where to anchor
the lead at the entry site:
• Contraction of the heart and other movement of the patient should not
put tension on the fixated lead.
• The tricuspid valve's function must not be hindered by the lead
CAUTION
Anchoring Sleeve—Always use an anchoring sleeve (lead fixation sleeve)
when implanting a lead. Use of the anchoring sleeve, which is provided with
the lead, will lessen the possibility of lead dislodgment and protect the lead
body from damage by a securing ligature.
3.9 Connecting the Lead to the Device
In BIOTRONIK ICDs with a DF4 connection, the set screw of the DF4 port is accessible from the
labeled side of the housing.
WARNING
Blind Plugs—Always close unused ports with blind plugs. Open IS-1 or
DF-1 ports can cause undesired current flows to the body. Bodily fluid can
penetrate into the device and damage it.
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Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
NOTE:
Shock coil(s) and electrodes for ventricular sensing and pacing are commonly connected via the DF4
connection.
1. Remove the stylet and the stylet guide.
2. Using the screwdriver (provided with the active device), pierce the center of the silicone plug
vertically, and insert the tip of the screwdriver into the respective set screw.
3. Rotate the set screw counterclockwise with the screwdriver until the connector port of the active
device is completely clear.
4. Push the lead connector into the port without bending the conductor or rotating the lead
connector until the blue color mark of the DF4 connector becomes visible behind the set screw
block.
5. If the lead connector cannot be easily pushed into the connector port, sterile water may be used
for lubrication, any other agents are prohibited, however.
6. If the lead connector cannot be inserted completely, the set screw may be protruding into the
connector port of the set screw block. Carefully loosen the set screw without completely
unscrewing it, so that it does not become tilted upon retightening.
7. Turn the set screw clockwise until the torque control starts (you will hear a clicking sound).
• Carefully withdraw the screwdriver without retracting the set screw.
• The other contacts of the DF4 port are designed as spring contacts.
8. When the screwdriver is withdrawn, the silicone plug automatically seals the lead connector port
safely.
.
CAUTION
Set screw(s)—Failure to back off the set screw(s) may result in damage to
the lead(s), and/or difficulty connecting the lead(s).
Cross-Threading—To prevent cross-threading the set screw, do not back
the Set screw completely out of the threaded hole. Leave the screwdriver in
the slot of the set screw while the lead is inserted.
Over-Tightening—Do not over-tighten the set screw(s). Use only a torque
wrench which automatically prevents over-tightening.
Sealing System—Failure to properly insert the torque wrench into the
perforation at an angle perpendicular to the connector receptacle may
result in damage to the sealing system and its self-sealing properties.
PAGE 23
Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
3.10 Final Implant Steps and Defibrillation Testing
The ICD and/or lead system may be placed in the pocket at this time. The following steps will help
ensure appropriate chronic Protego Lead System function:
BIOTRONIK ICD leads are made of highly flexible materials. Depending on where the lead is implanted
and the patient’s anatomy, the lead may be longer than required. If this is the case, we recommend
placing the excess lead length around the ICD in loose loops (see figure below).
CAUTION
Lead Handling—Make sure that the lead is neither knotted, twisted, nor
bent at a sharp angle. This could cause damage to the conductors or result
in abrasion of the lead’s insulation.
Lead Positioning—If the ICD is implanted underneath the pectoral muscle,
ensure that no parts of the lead lie between the housing of the ICD and
the ribs. Chafing and pressure on the lead between the housing of the ICD
and the ribs could damage the lead’s insulation and thus cause premature
failure.
To prevent mechanical overstress from causing the failure of pacing/
sensing functions, make sure that the lead does not become pinched
between the clavicle and the first rib after implantation.
• Place the device into the pocket with the printed side facing anteriorly.
3.11 Testing the Complete Device System
WARNING
Resuscitation Availability—Do not perform induction testing unless an
alternate source of patient defibrillation such as an external defibrillator is
readily available.
A final function test of the device system, including defibrillation, must be performed when the ICD
has been implanted and the lead has been connected. To do so, communication with the test or
programming devices is to be established via the programming head.
An external defibrillator must be readily available at all times because the patient is temporarily in a lifethreatening state during this test.
PAGE 24
Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
CAUTION
Shock Impedance—Never implant a device with a lead system that has a
measured shock impedance that is less than what is recommended in the
appropriate ICD technical manual. Damage to the device may result. If the
shock impedance is less than the recommended value, reposition the lead
system to allow a greater distance between the electrodes.
WARNING
Defibrillation Threshold—Be aware that changes in the patient’s condition,
drug regimen, and other factors may affect the defibrillation threshold (DFT)
which may result in nonconversion of the arrhythmia post-operatively.
Successful conversion of ventricular fibrillation or ventricular tachycardia
during arrhythmia conversion testing is no assurance that conversion will
occur post‑operatively.
• Close the device pocket using standard surgical technique. Ensure the ICD detection status has
been deactivated prior to using electrocautery.
• If a Protego lead is being implanted without an ICD at this time, the lead connector must be capped
with an appropriate lead cap and carefully laid in the subcutaneous pocket. Ensure that the lead
system is carefully coiled and not twisted.
PAGE 25
Chapter 3 Implant Procedure
Protego Steroid Eluting ICD Leads Technical Manual
PAGE 26
Chapter 4 Follow-Up Procedures
Protego Steroid Eluting ICD Leads Technical Manual
4. Follow-Up Procedures
4.1 ICD Patient Follow-Up
Follow the instructions described in the appropriate BIOTRONIK ICD technical manual.
4.2 Explantation
To explant the Protego S or Protego SD lead, the fixation helix must be fully retracted. An explanted
lead may not be reused. Please complete the appropriate explant form and return the form to
BIOTRONIK with the explanted lead system. Explanted devices should be sent to BIOTRONIK for
analysis and/or disposal. Contact BIOTRONIK if you are in need of assistance with returning any
explanted devices. The explanted devices should be cleaned with a sodium hypochlorite solution of at
least 1% chlorine rinsed with water prior to shipping.
CAUTION
Resterilization—These devices are intended for single use. Do not
resterilize and re-implant explanted leads.
PAGE 27
Chapter 4 Follow-Up Procedures
Protego Steroid Eluting ICD Leads Technical Manual
PAGE 28
Chapter 5 Package Contents
Protgeo Steroid Eluting ICD Leads Technical Manual
5. Package Contents
Protego S Lead
The Protego S lead and contents of the inner blister package are sterile. Each Protego S Lead system
package contains:
• 1 Protego S 60, Protego S 65 or Protego S 75 lead with one silicone anchoring sleeve attached
and a pre-inserted stylet (0.36 mm)
• 1 stylet (0.36 mm)
• 2 stylets (0.38 mm)
• 1 stylet guide
• 2 fixation tools
• 1 vein lifter
Protego T Lead
The Protego T lead and contents of the inner blister package are sterile. Each Protego T Lead system
package contains:
• 1 Protego T 65 lead with one silicone anchoring sleeve attached and a pre-inserted stylet
(0.36 mm)
• 1 stylet (0.36 mm)
• 2 stylets (0.40 mm)
• 1 stylet guide
• 1 vein lifter
Protego SD Lead
The Protego SD lead and contents of the inner blister package are sterile. Each Protego SD Lead system
package contains:
• 1 Protego SD 60/xx, Protego SD 65/xx or Protego SD 75/xx lead with one silicone anchoring
sleeve attached and a pre-inserted stylet (0.36 mm)
• 1 stylet (0.36 mm)
• 2 stylets (0.38 mm)
• 1 stylet guide
• 2 fixation tools
• 1 vein lifter
Protego TD Lead
The Protego TD lead and contents of the inner blister package are sterile. Each Protego TD Lead
system package contains:
• 1 Protego TD 65/xx or Protego TD 75/xx lead with one silicone anchoring sleeve attached and a
pre-inserted stylet (0.36 mm)
• 1 stylet (0.36 mm)
• 2 stylets (0.40 mm)
• 1 stylet guide
• 1 vein lifter
PAGE 29
Chapter 5 Package Contents
Protego Steroid Eluting ICD Leads Technical Manual
PAGE 30
Chapter 6 Technical Data (Protego Passive Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
6. Technical Data (Protego Passive Fixation Leads)
DF4-LLHH (RV)
1.8 mm², Ir
24.5 mm², Ir
410 mm²
290 mm²
0.75 mg DXA
9 mm
15 mm
160/180 mm
Table 5: General Specifications
Protego TD
Protego T
65, 75
65
Quadripolar
Tripolar
Connectors
1 x DF4
1 x DF4
Connector Pin Material
MP35N
MP35N
Pt/Ir
Pt/Ir
Passive fixation,
with four silicone tines
Passive fixation,
with four silicone tines
2.6 mm (7.8 F)
2.6 mm (7.8 F)
8F
8F
Leads, Length (cm)
Polarity
Connector Ring Contact Material
Fixation Type
Lead Diameter
Diameter of Recommended Introducer
Table 6: Tip Electrode Specifications - Linoxsmart and Protego Leads
Protego TD
Protego T
Passive fixation with 4
silicone tines
Passive fixation with 4
silicone tines
1.8 mm²
1.8 mm²
90% Pt / 10% Ir
90% Pt / 10% Ir
Iridium, fractal
Iridium, fractal
Coil
Coil
Conductor Material
MP35N
MP35N
Outer Diameter of Inner Conductor Coil
0.70 mm
0.70 mm
4
4
≤ 85 Ω (65 cm length)
≤ 100 Ω (75 cm length)
≤ 85 Ω (65 cm length)
Fixation Design
Electrically Active Surface Area
Base Material
Surface Material, Structure
Conductor Style
Number of Filaments
Conduction Resistance
PAGE 31
Chapter 6 Technical Data (Protego Passive Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
Table 7: Steroid Collar
Active Pharmaceutical Agent (API)
DXA Content
Steroid Carrier
Protego TD
Protego T
DXA
DXA
0.75 mg
0.75 mg
Silastic 7-6860
Silastic® 7-6860
®
Table 8: Ring Electrode
Protego TD
Protego T
Surface Area
24.5 mm
Base Material
80% Pt / 20% Ir
80% Pt / 20% Ir
Iridium, fractal
Iridium, fractal
Tip to Ring Distance
9 mm
9 mm
Conductor Style
Cable
Cable
Conduction Material
MP35N
MP35N
Number of Filaments
7*7 (cable)
7*7 (cable)
≤ 45 Ω (65 cm length)
≤ 50 Ω (75 cm length)
≤ 45 Ω (65 cm length)
Surface Material, Structure
Conduction Resistance
2
24.5 mm2
Table 9: RV Coil
Protego TD
Protego T
2.9 cm2
2.9 cm2
2.6 mm (7.8F)
2.6 mm (7.8F)
5.0 cm
5.0 cm
90% Pt / 10% Ir with
Tantalum core
90% Pt / 10% Ir with
Tantalum core
Distance From Lead Tip
15 mm
15 mm
Conductor Style
Cable
Cable
MP35N/DFT (41% Ag)
MP35N/DFT (41% Ag)
7*7
7*7
≤ 1.6 Ω (65 cm length)
≤ 1.9 Ω (75 cm length)
≤ 1.6 Ω (65 cm length)
Geometric Surface Area
Diameter
Length
Base Material
Conduction Material
Number Of Filaments
Conduction Resistance
* MP35N®, MP and Multiphase are registered trademarks of the Standard Pressed Steel Co.
PAGE 32
Chapter 6 Technical Data (Protego Passive Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
Table 10: SVC Coil
Protego TD
Geometric Surface
Diameter
Length
Base Material
Distance From Lead Tip
Conductor Style
Conduction Material
Number Of Filaments
Conduction Resistance
Protego T
4.1 cm
4.1 cm2
2.6 mm (7.8F)
2.6 mm (7.8F)
7.0 cm
7.0 cm
90% Pt / 10% Ir
with Tantalum core
90% Pt / 10% Ir
with Tantalum core
16, 18 cm
16, 18 cm
Cable
Cable
MP35N/DFT (41% Ag)
MP35N/DFT (41% Ag)
7*7
7*7
≤ 1.2 Ω (65 cm length)
≤ 1.4 Ω (75 cm length)
≤ 1.2 Ω (65 cm length)
≤ 1.4 Ω (75 cm length)
2
PAGE 33
Chapter 6 Technical Data (Protego Passive Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
PAGE 34
Chapter 7 Technical Data (Protego Active Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
7. Technical Data (Protego Active Fixation Leads)
DF4-LLHH (RV)
4.5 mm², Ir
24.5 mm², Ir
290 mm²
410 mm²
1 mg DXA
1.8 mm
11 mm
17 mm
160 /180 mm
Table 11: General Specifications
Protego SD
Protego S
61, 65, 75
61, 65, 75
Quadripolar
Tripolar
Connectors
1 x DF4
1 x DF4
Connector Pin Material
MP35N
MP35N
Pt/Ir
Pt/Ir
Active Fixation Helix
Active Fixation Helix
2.6 mm (7.8F)
2.6 mm (7.8F)
8 F
8 F
Leads, Length (cm)
Polarity
Connector Ring Contact Material
Fixation Type
Lead Diameter
Diameter of Recommended Introducer
Table 12: Steroid Collar Specifications - Linoxsmart and Protego Leads
Parameter
Active Pharmaceutical Agent (API)
DXA content
Steroid Carrier
Protego SD
Protego S
DXA
DXA
1.0 mg
1.0 mg
Silastic 7-6860
Silastic® 7-6860
®
PAGE 35
Chapter 7 Technical Data (Protego Active Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
Table 13: Tip Electrode
Parameter
Protego SD
Protego S
Electrically active,
extendable / retractable
helix
Electrically active,
extendable / retractable
helix
Maximum Number of Turns for Helix
Extension
20
20
Maximum Length of Extended Helix
1.8 mm
1.8 mm
Fixation Helix: Wire Diameter
0.25 mm
0.25 mm
Electrically Active Surface Area
4.5 mm2
4.5 mm2
70% Pt / 30% Ir
70% Pt / 30% Ir
Iridium, fractal
Iridium, fractal
Coil
Coil
Conductor Material
MP35N
MP35N
Outer Diameter of Inner Conductor Coil
0.70 mm
0.70 mm
4
4
≤ 50 Ω (61, 65 cm length)
≤ 60 Ω (75 cm length)
≤ 50 Ω (61, 65 cm length)
≤ 60 Ω (75 cm length)
Fixation Design
Base Material
Surface Material, Structure
Conductor Style
Number Of Filaments
Conduction Resistance
Table 14: Ring Electrode
Parameter
Protego SD
Protego S
Surface Area
24.5 mm²
24.5 mm²
Base Material
80% Pt / 20% Ir
80% Pt / 20% Ir
Iridium, fractal
Iridium, fractal
Tip to Ring Distance
11 mm
11 mm
Conductor Style
Cable
Cable
MP35N
MP35N
7*7(cable)
7*7(cable)
≤ 45 Ω (61, 65 cm length)
≤ 50 Ω (75 cm length)
≤ 45 Ω (61, 65 cm length)
≤ 50 Ω (75 cm length)
Surface Material, Structure
Conductor Material
Number of Filaments
Conduction Resistance
* MP35N®, MP and Multiphase are registered trademarks of the Standard Pressed Steel Co.
PAGE 36
Chapter 7 Technical Data (Protego Active Fixation Leads)
Protego Steroid Eluting ICD Leads Technical Manual
Table 15: RV Coil
Parameter
Protego SD
Protego S
2.9 cm²
2.9 cm²
2.6 mm (7.8 Fr)
2.6 mm (7.8 Fr)
5.0 cm
5.0 cm
90% Pt / 10% Ir
with Tantalum core
90% Pt / 10% Ir
with Tantalum core
Distance From Lead Tip
17 mm
17 mm
Conductor Style
Cable
Cable
MP35N/DFT (41% Ag)
MP35N/DFT (41% Ag)
7*7
7*7
≤ 1.6 Ω (61, 65 cm length)
≤ 1.9 Ω (75 cm length)
≤ 1.6 Ω (61, 65 cm length)
≤ 1.9 Ω (75 cm length)
Geometric Surface Area
Diameter
Length
Base Material
Conductor Material
Number of Filaments
Conduction Resistance
Table 16: SVC Coil Specifications - Linoxsmart and Protego Leads
Parameter
Geometric Surface Area
Diameter
Length
Base Material
Distance From Lead Tip
Conductor Style
Conductor Material
Number of Filaments
Conduction Resistance
Protego SD
Protego S
4.1 cm²
N/A
2.6 mm (7.8 Fr)
N/A
7.0 cm
N/A
90% Pt / 10% Ir
with Tantalum core
N/A
16, 18 cm
N/A
Cable
N/A
MP35N/DFT (41% Ag)
N/A
7*7
N/A
≤ 1.2 Ω (61, 65 cm length)
≤ 1.4 Ω (75 cm length)
N/A
PAGE 37
Chapter 8 Disclaimer
Protego Steroid Eluting ICD Leads Technical Manual
8. Disclaimer
BIOTRONIK leads, lead extensions, adapters and accessories used in connection with these devices
(referred to as: leads and accessories) have been qualified, manufactured and tested in accordance
with well proven and accepted standards and procedures. The physician should be aware, however,
that leads and accessories may be easily damaged by improper handling or use. Except as set forth in
BIOTRONIK’s Lead Limited Warranty, BIOTRONIK makes no express or implied warranties for its leads
and accessories.
PAGE 38
Protego Steroid Eluting ICD Leads
Technical Manual
M4158-A 05/14
©2014 BIOTRONIK, Inc. All rights reserved.
MN025 5/20/14
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394 (24-hour)
(800) 291-0470 (fax)
www.biotronik.com