CARDIOVASCULAR
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Safire™ TX Bi-directional Ablation Catheters
8 mm Tip Universal Temperature Monitoring

Quadripolar
7 F

PRODUCT HIGHLIGHTS

  • Bi-directional tip deflection
  • Automatic steering lock reduces catheter manipulation
  • Dual Thermocouple and Single Thermistor temperature monitoring capability
  • ComfortGrip™ ergonomic handle

ORDERING INFORMATION

Contents: 7 F Quadripolar Catheters (1 unit per box)


Reorder Number Electrode Spacing (mm) Tip Electrode (mm) Band Electrode (mm) Distal Reach Usable Length (cm)
402838 2-5-2 8 1 Sm Curve 110
402839 2-5-2 8 1 Med Curve 110
402840 2-5-2 8 1 Lrg Curve 110
402841 2-5-2 8 1 X-Lrg Curve 110
402842 2-5-2 8 1 Extended Reach Curve 110
402843 2-5-2 8 1 Far Reach Curve 110
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Required Catheter Extension Cables

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Safire™ TX Bi-directional Ablation Catheters 8 mm Tip Universal Temperature Monitoring Quadripolar 7 F

Rx Only

Brief Summary: 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.

INDICATIONS

The Therapy™ Cardiac Ablation System is indicated for mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.

CONTRAINDICATIONS

In patients with active systemic infection. In patients with intracardiac mural thrombus, ventriculotomy or atriotomy within the preceding four weeks.

WARNINGS

Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long term risks of RF ablation lesions have not been established. Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block.

PRECAUTIONS

Appropriate DIP pads should be used to minimize skin burns.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including complete heart block requiring pacemaker. Please refer to the Instructions for Use for a complete list.

 

SJM-CAG-0915-0035t(1)

Last Updated: January 02, 2019

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Reorder Number Compatible Generator
402578 SJM
402579 Stockert
402577 EPT