Boston Scientific EASYTRAK 2 IS-1, Physician'S Lead Manual

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DEVICE DESCRIPTION—EASYTRAK 2 IS-1 LEAD
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DEVICE DESCRIPTION
Boston Scientific EASYTRAK™ 2 IS-1 coronary venous pace/sense leads,
Models 4542/4543/4544, provide chronic, dual-electrode pacing and
sensing. The leads have an over-the-wire design with an IS-1
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bipolar
connector (two electrodes) and are steroid-eluting near the distal electrode.
The lead electrodes are IROX™-coated (iridium oxide). Placement is
achieved by inserting the lead through the coronary sinus and placing it into
a branch of the cardiac veins. The EASYTRAK 2 IS-1 lead is used in
conjunction with a compatible Boston Scientific cardiac resynchronization
therapy (CRT) heart failure device.
Indications
The Boston Scientific EASYTRAK 2 IS-1 coronary venous pace/sense
leads, Models 4542/4543/4544, are transvenous leads intended for chronic,
left-ventricular dual-electrode pacing and sensing via the coronary veins
when used in conjunction with a compatible Boston Scientific cardiac
resynchronization therapy (CRT) heart failure device that accepts the IS-1
connector.
Contraindications
Use of the EASYTRAK 2 IS-1 lead is contraindicated in patients with a
hypersensitivity to a nominal single dose of 0.7 mg of dexamethasone
acetate drug.
Warnings
• Read this manual thoroughly before implanting the lead to avoid damage
to the system. Such damage can result in injury to or death of the
patient.
• When using a right ventricular (RV) pace/sense lead in conjunction with
the EASYTRAK 2 IS-1 lead, it is recommended that a
polyurethane-
insulated lead be used. Failure to observe this warning could result in
insulation damage of the RV lead, which can cause a periodic or
continual loss of pacing, or sensing, or both.
• Lead fracture, dislodgment, abrasion, or an incomplete connection can
cause a periodic or continual loss of pacing or sensing or both.
1. IS-1 refers to the international standard ISO 5841.3:2000.
EASYTRAK is a trademark of Boston Scientific Corporation or its affiliates.
IROX is a trademark of Boston Scientific Corporation or its affiliates.
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