OptiSense™ Pacing Lead
CARDIOVASCULAR
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OptiSense

Pacing Lead

OptiSense<sup>®</sup>

PRODUCT HIGHLIGHTS

  • OptiSense lead technology offers optimal tip-to-ring spacing for more precise atrial sensing without inappropriately sensing extra-atrial signals

– Unique 1,1 mm tip-to-ring spacing enables sensing of even the finest atrial arrhythmia signals (standard atrial leads typically have a tip-to-ring spacing of 10 mm or more)

– Accurate atrial sensing enables appropriate atrial diagnostics and therapies

  • Less far-field R-wave interference with innovative far-field signal reduction technology
  • Optim lead insulation—a chemical co-polymer that blends the best features of polyurethane and silicone for improved handling and increased durability
  • Thin lead body diameter of 5,8 F can be inserted using a 7 F introducer
  • Steroid elution and titanium nitride fractal coating on electrodes for low thresholds
  • Includes three different J-shaped stylets providing options for different patient anatomies and handling preferences

ORDERING INFORMATION

Contents: Cardiac pacing lead


Reorder Number Insulation Fixation Minimum Introducer (F) Connector Lengths (cm)
1999/40 Optim Ext/Ret Helix 7 IS-1 bipolar 40
1999/46 Optim Ext/Ret Helix 7 IS-1 bipolar 46
1999/52 Optim Ext/Ret Helix 7 IS-1 bipolar 52


Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Indications: The OptiSense lead is designed for permanent sensing and pacing in the atrium with a compatible pulse generator. An active lead, such as the OptiSense, may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead, such as the OptiSense, may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

Contraindications: The OptiSense lead is contraindicated: In the presence of tricuspid atresia, for patients with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

Adverse Events: Potential complications associated with the use of OptiSense leads are the same as with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation, embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and, rarely, death.

Refer to the User’s manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Item GMCRM910EN

Last Updated: December 18, 2018

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