CARDIOVASCULAR
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OptiSense®

Pacing Lead

OptiSense®

PRODUCT HIGHLIGHTS

  • OptiSense® lead technology with optimal tip-to-ring spacing - For physicians who want the assurance that the atrial lead can sense fine atrial arrhythmias without inappropriately sensing extra-atrial signals, the unique 1.1 mm tip-to-ring spacing offers a more precise measurement of atrial signals when compared with other leads used in the atrium.
  • More accurate atrial sensing - Due to less far-field interference, the lead allows increased atrial sensitivity settings and negates the need to use extended blanking periods.
  • Less far-field interference - With innovative far-field signal reduction technology, the lead:
    • Reduces paced far-field R-waves by 94%.*
    • Eliminates inappropriate mode switching.*
  • Optim® lead insulation blends the best qualities of silicone and polyurethane.
  • Thin 5.8 F lead body diameter enables use of a 7 F introducer.

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

* 120 patient multi-center FSR clinical study in Europe - completed 2008: Tendril® FSR Model 1699T Lead Study Final Report (IDE#G050207).


CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The OptiSense® Model 1999 lead is designed for permanent sensing and pacing in the right atrium in combination with a compatible pulse generator. Active-fixation leads such as the Model 1999 lead 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 may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

Contraindications: The OptiSense® Model 1999 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.

Potential Adverse Events: Potential complications associated with the use of the lead are the same as with the use of any lead.

Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Rev.6-012511

Last Updated: January 02, 2019

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