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CARDIOVASCULAR

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TactiFlex Ablation Catheter, Sensor Enabled

Acute Clinical Success

TactiFlex
Clinical Evidence

Acute Clinical Success

TactiFlex™ Ablation Catheter, Sensor Enabled™ acute IDE study results1,2

High-power (time-averaged power setting 40-50W) versus low-power (time-averaged power setting < 40W)

99.4%

Ablation

Acute Success*

80.5%

Ablation Rate

81.8% High-Power
77.3% Low-Power

First-Pass PVI Success**

2.4%

Ablation

1.3% High-Power
5.2% Low-Power

Rate of Repeat Ablation in Blanking Period

4.3%***

Safety Endpoint

4.1% High-Power
5.2% Low-Power

Subjects with Primary Safety Endpoint Event at 90 Days

Shorter ablation and procedure times, less fluoro and irrigation3,4

All power levels up to 50W

Total Procedure Time****
Total Procedure Time
Total PV Ablation Time****
Total PV Ablation Time
Total Fluoroscopy Time
Total Fluoroscopy Time
Irrigation Fluid Volume
Irrigation Fluid Volume

Comparing acute results from high- and low-power groups1

Total Procedure Time****
Total Procedure Time
Total RF time for PV Ablation
Total PV Ablation Time
Total Fluoroscopy Time
Total Fluoroscopy Time
Total Irrigation Fluid Volume
Irrigation Fluid Volume
Total Irrigation Fluid Volume

LP = low-power (time-averaged power <40W)
HP = high-power (time-averaged power 40-50W)

Manuals & Technical Resources

Manuals & Technical Resources

Customer Service

Customer Service

This device is commercially available for use in select international markets.

* Isolation of all pulmonary veins, confirmed by entrance block, by the end of the procedure.
** The percentage of treated patients with isolation of all pulmonary veins after a minimum 20-minute waiting period.
*** Endpoint population (main study)
**** Includes 20-minute waiting period.

 

References

  1. CL1017540 TactiFlex PAF IDE PMA Report.
  2. CL1019990 TactiFlex PAF IDE As Treated Repeat Procedure Details.
  3. CL1021674 TactiFlex and TactiSense Additional Analysis
  4. CL1004955 TactiSense PMA Report. TactiSense is the PAF IDE study for TactiCath Ablation Catheter, Sensor Enabled.

MAT-2208527 v3.0

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