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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 ≥ 40-50 W) 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 irrigation4

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

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

Manuals & Technical Resources

Manuals & Technical Resources

Order Cardiovascular Products

Cardiovascular Products

Customer Service

Customer Service

* 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.

MAT-2302269 v1.0

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MAT-1900882 v10.0