IsoFlex™ Optim™ Pacing Lead
CARDIOVASCULAR
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IsoFlex™ Optim™

Pacing Lead

PRODUCT HIGHLIGHTS

  • The IsoFlex Optim lead allows patients to undergo a 1.5 T or 3 T MRI scan when used in conjunction with a MRI Ready pacemaker from Abbott*
  • Straight or J-shaped lead is available in multiple lengths to accommodate varying needs and patient anatomies
  • Optim™ lead insulation—a chemical co-polymer that blends the best features of polyurethane and silicone— provides improved handling and increased durability
  • Symmetrical lead body with coaxial multifilar coils for reliability
  • Steroid-eluting tip for reduced inflammation at the lead-tissue interface and low pacing thresholds
  • Small tip surface area for higher impedance levels and optimal device longevity
  • Titanium nitride (TiN) coated tip and ring electrode for low polarization values and compatibility with the AutoCapture™ pacing system algorithm
  • Radiopaque suture sleeve for visibility under fluoroscopy to simplify invasive procedures

ORDERING INFORMATION


Reorder Number Description Insulation Fixation Minimum Introducer (F) Connector Length (cm)
1944/46 IsoFlex™ Optim™ Pacing Lead Optim™ Tines 7 IS-1 bipolar 46
1944/52 IsoFlex™ Optim™ Pacing Lead Optim™ Tines 7 IS-1 bipolar 52
1948/52 IsoFlex Optim Pacing Leads Optim Tines 7 IS-1 bipolar 52
1948/58 IsoFlex Optim Pacing Leads Optim Tines 7 IS-1 bipolar 58

Reorder Number Description Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector

*See MRI conditional parameters.


Rx Only

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 Abbott representative for product availability in your country.

Indications: IsoFlex™ Optim™ Model 1948 leads are 7F, steroid eluting (DSP), 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 7F, steroid eluting (DSP), 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.

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

SJM-IFX-1214-0002(2)

Last Updated: January 02, 2019

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