CARDIOVASCULAR
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IsoFlex® S

Pacing Lead

IsoFlex® S

PRODUCT HIGHLIGHTS

  • Reduced lead body diameter allows for insertion through narrow and tortuous veins.
  • Small surface area (3.5 mm2) tip electrode for higher impedance.
  • Radiopaque suture sleeve is highly visible under fluoroscopy.
  • Silicone insulation with FastPass® coating for increased lead lubriciousness and improved handling.

ORDERING INFORMATION

Contents: Cardiac pacing lead


Reorder Number Shape Insulation Fixation Minimum Introducer (F) Connector Lengths (cm)
1642T/40 J Silicone Tines 7 IS-1 bipolar 40
1642T/46 J Silicone Tines 7 IS-1 bipolar 46
1642T/52 J Silicone Tines 7 IS-1 bipolar 52
1643K/40 J Silicone Tines 7 IS-1 unipolar 40
1643K/46 J Silicone Tines 7 IS-1 unipolar 46
1643K/52 J Silicone Tines 7 IS-1 unipolar 52
1645K/34 Straight Silicone Tines 7 IS-1 unipolar 34
1645K/40 Straight Silicone Tines 7 IS-1 unipolar 40
1645K/46 Straight Silicone Tines 7 IS-1 unipolar 46
1645K/52 Straight Silicone Tines 7 IS-1 unipolar 52
1645K/58 Straight Silicone Tines 7 IS-1 unipolar 58
1645K/85 Straight Silicone Tines 7 IS-1 unipolar 85
1646T/34 Straight Silicone Tines 7 IS-1 bipolar 34
1646T/40 Straight Silicone Tines 7 IS-1 bipolar 40
1646T/46 Straight Silicone Tines 7 IS-1 bipolar 46
1646T/52 Straight Silicone Tines 7 IS-1 bipolar 52
1646T/58 Straight Silicone Tines 7 IS-1 bipolar 58
1646T/85 Straight Silicone Tines 7 IS-1 bipolar 85
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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 IsoFlex® S lead is designed for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1643K and 1642T are j-shaped) or ventricle (Models 1645K or 1646T).

Contraindications: The use of IsoFlex® S leads is contraindicated in patients who are expected to be hypersensitive to a single dose of 1.0 milligram of dexamethasone sodium phosphate.

The use of Models 1645K and 1646T is also contraindicated in the presence of tricuspid atresia and in patients with mechanical tricuspid valves.

Potential Adverse Events: The IsoFlex® S pacing lead clinical trial involved 65 Model 1642T and 93 Model 1646T leads implanted in 95 patients. Cumulative implant duration by lead location is as follows: atrium: 7704 days (mean implant duration 120.4 days, range 1 to 210 days), ventricle: 12144 days (mean implant duration 129.2 days, range 35 to 219 days).

No deaths were reported.

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

Rev.6-012511

Last Updated: January 02, 2019

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