Boston Scientific FLEXTEND - User Manual

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)
Tech.Services@guidant.com
Technical Services – Europe
+32 2 416 7222
eurtechservice@guidant.com
LATITUDE Clinician Support
1.800.CARDIAC (227.3422)
latitude@guidant.com
Patient Services
1.866.484.3268 – U.S. and Canada
001.651.582.4000 – International

Summary

Exercise the Helix Before Implant

Verify Helix Functionality

Check mechanical function by rotating the terminal pin to extend/retract the helix mechanism.

Helix Extension and Retraction

Rotate terminal pin clockwise to extend and counterclockwise to retract the helix 6-8 turns.

Position the Lead

Atrial Lead Placement

Advance lead into the right atrium using a straight stylet and ensure endocardial contact.

Ventricular Lead Placement

Advance lead through tricuspid valve, ensure correct ventricle position via fluoroscopy.

Fixate the Lead Helix

Attaching and Rotating Fixation Tool

Attach fixation tool, apply pressure, rotate clockwise 6-8 turns to fixate helix into heart wall.

Verifying Fixation

Use fluoroscopy to confirm radiopaque markers are joined and helix is extended.

Check for Lead Stability

Stylet Withdrawal and Stability Check

Partially withdraw stylet, check stability via fluoroscopy, and completely withdraw stylet.

Reposition the Lead

Helix Retraction for Repositioning

Reattach fixation tool, rotate counterclockwise to retract helix, then reapply positioning steps.

Evaluate Electrical Performance

Recommended Threshold Measurements

Verify voltage, current, amplitude, and impedance meet recommended values after fixation.

Secure the Lead

Suture Sleeve Securing

Secure the lead to the vein using provided suture sleeves after successful positioning and fixation.

Boston Scientific FLEXTEND Specifications

General

Compatible Guide Catheter Size	6F
Single Use	Yes
Available Lengths	20 mm
Brand	FLEXTEND
Model	FLEXTEND
Sterility	Sterile