CARDIOVASCULAR
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IsoFlex® Optim®

Pacing Lead

IsoFlex<sup>TM</sup> Optim<sup>TM</sup>

PRODUCT HIGHLIGHTS

  • Combines the reliable lead design of the IsoFlex lead family with the improved control provided by the innovative Optim lead insulation.
  • Optim lead insulation blends the best qualities of silicone and polyurethane for abrasion resistance as well as better lubricity and handling.
  • Includes steroid-eluting tip, which reduces tissue inflammation to provide low stimulation thresholds.
  • Offers titanium nitride tip for improved sensing and compatibility with the St. Jude Medical AutoCapture™ Pacing System feature.
  • Available in ventricular and pre-formed atrial J-shaped models and multiple lead lengths to provide options for varying anatomies.

ORDERING INFORMATION

Contents: Cardiac pacing lead


Reorder Number Shape Insulation Fixation Minimum Introducer (F) Connector Length (cm)
1944/46 J Optim™ Tines 7 IS-1 bipolar 46
1944/52 J Optim™ Tines 7 IS-1 bipolar 52
1948/46 Straight Optim™ Tines 7 IS-1 bipolar 46
1948/52 Straight Optim Tines 7 IS-1 bipolar 52
1948/58 Straight Optim Tines 7 IS-1 bipolar 58
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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: IsoFlex® Optim® Model 1948 leads are 7 F, steroid-eluting (DXA), passive-fixation (tined) straight body leads designed for use with compatible pulse generators to provide permanent pacing and sensing in either the right atrium or right ventricle. IsoFlex Optim Model 1944 leads are 7 F, steroid-eluting (DXA), passive-fixation (tined) J-shaped leads designed for use with compatible pulse generators to provide permanent pacing and sensing in the right atrium.

Contraindications: The use of IsoFlex® Optim® 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 the Model 1948 is also contraindicated in the presence of tricuspid atresia and in patients with mechanical tricuspid valves.

Potential Adverse Events: Potential complications associated with use of the IsoFlex Optim family of leads are the same as with the use of other passive fixation leads and include: cardiac perforation, cardiac tamponade, damage to vessels, embolism, excessive bleeding, induced atrial or ventricular arrhythmias, infection, loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the lead, phrenic nerve stimulation, tissue necrosis, thrombosis, valve damage. Phrenic nerve or direct diaphragmatic stimulation may also be a result of lead position. 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.

Rev.6-012511

Last Updated: January 02, 2019

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