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Safire™ BLU™ Ablation Catheter

New, High Performance Shaft For Exceptional Control

The Safire BLU Ablation Catheter features a new, high performance shaft with improved torque response offering exceptional catheter control.The bi-directional deflection provides the maneuverability to reach challenging anatomic locations.
Safire BLU™ Ablation Catheter (US Only)
Overview
  • New shaft design provides exceptional torque response for improved catheter control1 with soft distal section for atraumatic performance2
  • Bi-directional deflection for improved maneuverability to reach challenging anatomic locations
  • Compatibility with the SJM Cardiac Ablation Generator featuring closed loop temperature control mode operation designed for efficient RF power delivery
  • Cool Point™ lrrigation Pump features exclusive in-line bubble and occlusion detection for added performance
  • Up to 56% lower flow rate during RF delivery than competitive irrigated ablation catheters3, which can reduce overall patient fluid loading

References

1 Data on file at St. Jude Medical - Report #90061538.
2 Data on file at St. Jude Medical - Report #90061537.
3 When comparing the SJM IBI-1500T9 irrigated ablation system (flow rate - 13 ml/min) vs. the ThermoCool catheter and Stockert 70 generator with Cool Flow pump operated at 30 W or less (flow rate - 17 ml/min) and greater than 30W (flow rate - 30 ml/min).

Tech Specs

Safire™ BLU™ Bi-directional Ablation Catheter Irrigated 4 mm Tip Thermocouple

Quadripolar
7 F
Ordering Information   View Catalog   

Contents: 7 F 4 mm irrigated ablation catheter (1 unit per box)

Reorder Number Description Electrode Spacing (mm) Tip Electrode (mm) Band Electrode (mm) Distal Reach Usable Length (cm)
A402869 1304-CPS-7-25-MS-BD 2-5-2 4 2 Medium Sweep 110
A402871 1304-CPS-7-25-MC-BD 2-5-2 4 2 Medium Curl 110
A402870 1304-CPS-7-25-LS-BD 2-5-2 4 2 Large Sweep 110
A402872 1304-CPS-7-25-LC-BD 2-5-2 4 2 Large Curl 110

Required Catheter Extension Cables
Reorder Number Compatible Generator
85641 SJM

Evidence

Torque Transmission

Torque transmission allows the physician to effectively torque the catheter tip into tissue. During bench testing, torsion force measurements were taken at the distal tip of each catheter shaft as the catheter was rotated 180° at the proximal end by the test equipment. A higher measurement indicates greater torque responsiveness.Torque 180

Distal Shaft Stiffness

A catheter with too much distal shaft stiffness (column strength) may contribute to procedural complications as well as be less compliant to tissue during cardiac motion. Distal shaft stiffness is a measurement of the force required to cause the distal shaft section to collapse while in a perpindicular orientation. A higher measured force correlates to a higher distal shaft stiffness.

Distal Shaft


References

EZ Steer, ThermoCool, Celsius, Stockert and Cool Flow are registered or unregistered trademarks of Biosense Webster, Inc.

Indications, Safety & Warnings
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Safire™ BLU™ Bi-directional Ablation Catheter Irrigated 4 mm Tip Thermocouple

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 Cool Path Duo and Safire BLU Duo Irrigated Ablation Catheters are intended for use with a compatible irrigation pump and the 1500T9-CP RF Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical Atrial Flutter. The Therapy Cool Path and Safire BLU Irrigated Ablation Catheters are intended for use with a compatible external infusion pump and the 1500T9-CP RF Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical Atrial Flutter.

CONTRAINDICATIONS

In patients with active systemic infection. Via the retrograde transaortic approach in patients with aortic valve replacement. Via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. 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. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped can cause potential injury or fatality.

PRECAUTIONS

Appropriate DIP pads should be used to minimize skin burns. If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery MUST be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablating near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump.

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.

Last Updated: April 26, 2013