1
INFORMATION FOR USE
Device Description
The Boston Scientific Corporation RELIANCE 4-FRONT defibrillator lead is a
7.3 French (8F introducer), transvenous, steroid-eluting, integrated bipolar, DF-
4 compatible lead intended for permanent sensing, pacing, and defibrillation
when used with a compatible Implantable Cardioverter Defibrillator (ICD) or
Cardiac Resynchronization Therapy Defibrillator (CRT-D). The RELIANCE 4-
FRONT lead family offers active and passive fixation models and single and
dual coil models, with silicone-filled defibrillator coils.
This lead family has the following characteristics:
•
Endocardial cardioversion/defibrillation and pace/sense lead—intended for
chronic delivery of cardioverting/defibrillating shocks, and bipolar pacing
and sensing capabilities; implanted within the superior vena cava, right
atrium, and right ventricle.
•
4-FRONT integrated bipolar connector—intended to be connected to a
device with a DF4-LLHH port, which accepts either a DF4-LLHH or DF4-
LLHO lead. It is configured with in-line contacts and labeled as DF4-LLHH
or DF4-LLHO, described below:
–
DF4: indicates the lead contains high voltage contacts
1
–
L: indicates a connection to a low-voltage pace/sense electrode; first L
(terminal pin)—distal pace/sense electrode; second L (proximal ring
contact)—proximal pace/sense electrode
–
H: indicates a connection to a high-voltage defibrillation electrode; first
H (middle ring contact)—distal coil electrode; second H (distal ring
contact)—proximal coil electrode (dual-coil models)
–
O: indicates an inactive distal ring contact (single-coil models)
NOTE:
RELIANCE 4-FRONT leads with the DF4-LLHH/LLHO label are
equivalent and are compatible with a device containing either a GDT-LLHH
or DF4-LLHH port.
•
MR Conditional—leads can be used as part of the ImageReady MR
Conditional Defibrillation System when connected to Boston Scientific MR
Conditional pulse generators ("MR Conditional System Information" on
page 3).
•
Tip electrode—serves as the cathode for intracardiac right ventricular
pacing/sensing and uses an IROX coated electrode which may improve
pacing performance. Lower and more consistent pacing thresholds may
increase the pacing longevity of the pulse generator.
•
Coil electrodes—the distal coil electrode and the proximal coil electrode
(for dual-coil models) serve as the anode and cathode during
cardioversion/defibrillation shocks. The distal coil also serves as the anode
for pacing and sensing.
1.
DF4 refers to the international standard ISO 27186:2010.
