Boston Scientific FLEXTEND Assembly instructions

FLEXTEND
®
Lead Implant Tips
Exercise the Helix Before Implant
December 13, 2007 ©2007 Boston Scientific Corporation or its affiliates. All rights reserved. Page 1 of 3
Before implanting the lead, verify the mechanical functioning of the helix by rotating the
terminal pin to visually observe extension and retraction of the helix mechanism.
1. Attach the fixation tool to the terminal pin of the lead. Squeeze the handles together and
place the pin in the preformed groove. Release the tension on the handles to secure the
terminal pin in the fixation tool (Figure 1).
Figure 1. Fixation tool attached to terminal pin
2. Rotate the terminal pin clockwise approximately 6 to 8 turns (1 second per rotation) to
fully extend the helix.
3. Rotate the terminal pin counterclockwise approximately 6 to 8 turns (1 second per
rotation) to fully retract the helix into the lead body.
4. Remove the fixation tool by squeezing the handles of the tool together.
CAUTIONS:
•Do not over-extend or over-retract the helix. Exceeding the number of turns required to
extend or retract the helix can damage the lead.
•Do not use the lead if the helix cannot be extended or retracted or if the helix is
deformed.
Position the Lead
Atrial position Ventricular position
1. Advance the lead into the right atrium
using a straight stylet.
2. With the lead in the low right atrium,
insert the J-shaped or a curved straight
stylet.*
3. Gently pull the lead/stylet combination
at the venous entry site to ensure
contact between the lead tip and the
endocardium.
*Two different J-shape stylets are
provided. One has a longer reach and
may be suitable for most patient
anatomies.
1. Advance the lead into the right atrium using a straight stylet.
2. Advance the lead through the tricuspid valve or place the lead
tip against the lateral atrial wall and back the curved lead
body through the tricuspid valve. A curved stylet may
enhance maneuverability.
3. Use fluoroscopy (lateral position) to ensure that the lead is not
lodged in the coronary sinus and is in the ventricle.
4. Insert a stylet into the lead and gently push the lead/stylet
combination at the venous entry site to ensure contact
between the lead tip and the endocardium.
CAUTION:
•If the patient has a thin apical wall, consider an alternate
fixation site.
•If a conscious patient feels a sharp pain, this may be an indication
of perforation.
5. Minimize the application of lead tip pressure by partially
withdrawing the stylet during lead positioning. This will
minimize tip stiffness.
BACKGROUND INFORMATION
This article provides information to
enhance a user’s implant
experience with Boston Scientific’s
extendable/retractable FLEXTEND
and FLEXTEND 2 leads.
This article does not contain a
complete list of implant
instructions and is not intended
to supersede device-specific
labeling. For complete implant
instructions and potential risks,
please refer to the appropriate
Instructions For Use manual.
Lead fixation using an extendable
helix mechanism is one risk factor
for cardiac perforation. Refer to the
Product Update entitled
“Implantable Pacing Leads and Risk
of Cardiac Perforation” available on
www.bostonscientific.com for further
information.
CRM PRODUCTS REFERENCED*
FLEXTEND Models 4086 / 4087 / 4088;
FLEXTEND 2 Models 4095 / 4096 / 4097
*Products referenced herein may not be approved in all
geographies.
CRM CONTACT INFORMATION
Technical Services – U.S.
1.800.CARDIAC (227.3422)
[email protected]
Technical Services – Europe
[phone]
[email protected]
LATITUDE Clinician Support
1.800.CARDIAC (227.3422)
[email protected]
Patient Services
1.866.484.3268 – U.S. and Canada
001.651.582.4000 – International

The FLEXTEND helix is electrically conductive regardless of helix position. Thus, pacing and sensing thresholds can be
measured without extending the helix into the tissue. Mapping of the atrium or ventricle prior to helix extension and lead
fixation is recommended as it can reduce the potential need for repositioning.
Fixate the Lead Helix
With the lead in the correct position, fixate the lead in the following manner:
1. Attach the fixation tool to the terminal pin (Figure 1).
2. Apply adequate pressure to seat the distal electrode against the fixation site and slowly rotate the fixation tool
clockwise approximately 6 to 8 turns (1 second per rotation) to affix the distal electrode helix into the heart wall.
3. Do not release the fixation tool—hold it stationary.
4. Verify under fluoroscopy that the radiopaque markers are joined and the fixation helix is extended outside the
distal fluoroscopy marker (Figure 2).
Figure 2. Fluoroscopic markers illustrating appropriate retraction/extension
Marker
s
not
j
oined M
a
rk
e
r
s
jo
in
ed
Helix retracted H
e
lix
e
x
te
n
ded
5. If the markers are not joined, 1 to 2 additional turns may be necessary.
CAUTION: Minimize the number of turns. Excessive turns can cause damage to the lead, increased acute
thresholds, lead dislodgement and/or lead perforation.
6. Loosely hold the proximal end of the lead and release the fixation tool.
7. Remove the fixation tool by squeezing the handles of the tool together.
8. Carefully remove the stylet. Minimize manipulation of the lead to prevent dislodgement.
9. Ensure sufficient lead slack is present to prevent dislodgement.
If the helix mechanism fails to function properly during implant, the following caution must be observed to avoid
possible tissue snagging when removing the lead:
CAUTION: Do not use the lead if the helix cannot be retracted during implant. Continuous counterclockwise
rotation of the lead body during lead removal is necessary to avoid inadvertent tissue trauma.
Counterclockwise lead rotation helps to prevent accidental fixation and releases the electrode helix if tissue
snagging has occurred.
Check for Lead Stability
After fixation, partially withdraw the stylet 8 to 10 cm. Check the stability of the lead using fluoroscopy. Do not tug on the lead.
If possible, have the patient cough or take several deep breaths. When electrode position is satisfactory, completely withdraw
the stylet.
CAUTION: Should dislodgement occur, immediate medical care is required to resolve the electrode position
and minimize endocardial trauma.
Reposition the Lead
If lead repositioning is necessary,
•Verify the stylet is fully inserted into the lead
•Reattach the fixation tool and rotate the tool counterclockwise 6 to 8 turns to retract the helix. Do not over-rotate the
helix.
•The use of fluoroscopy may help to verify that the helix is retracted and disengaged completely from the heart wall.
•Reaffix the electrode using the positioning, fixation and checking for lead stability procedures described previously.
December 13, 2007 ©2007 Boston Scientific Corporation or its affiliates. All rights reserved. Page 2 of 3

Evaluate electrical performance of the lead
Verify the electrical performance of the lead before attaching the lead to the pulse generator and after allowing sufficient time
for the effect of local tissue trauma to subside. If the measurements do not conform to the recommended values listed in
Table 1, reposition and reaffix the electrode using the positioning technique discussed previously.
Table 1. Recommended threshold and sensing measurementsa
Atrial data Ventricular data
Voltage threshold b ≤1.5 V ≤1.0 V
Current threshold b ≤1.5 mA ≤1.5 mA
Intrinsic amplitude ≥2.0 mV ≥5.0 mV
Impedance 450-1800 Ω450-1800 Ω
Source: FLEXTEND Instructions For Use (355229).
aValues measured approximat y 10 minutes after fixation.el
b Pulse width setting at 0.5 ms.
NOTES:
•Electrical measurements immediately post-fixation may deviate from recommendations. Values may be
dependant on patient specific factors such as tissue condition, electrolyte balance and drug interactions.
•Over-rotation of terminal pin may increase local tissue trauma and cause temporarily high thresholds.
Secure the lead
After successful lead positioning and fixation, secure the lead to the vein using the suture sleeves provided (Figure 3). Suture
sleeve tie-down techniques can vary with the lead insertion technique used.
Figure 3. Suture sleeve
December 13, 2007 ©2007 Boston Scientific Corporation or its affiliates. All rights reserved. Page 3 of 3