Hot and cold intelligent induction ablation catheter for FDA approval for atrial fibrillation ablation

Release date: 2014-03-04


Recently, the FDA approved a radio frequency ablation catheter, the ThermoCool SmartTouch ablation catheter, which can be fed back in real time. The contact pressure measuring catheter can sense its contact with heart tissue and can be used for patients with paroxysmal symptomatic atrial fibrillation who are not responding to arrhythmia drugs. The FDA approved the use of the catheter based on the results of the SMART-AF trial reported last year by the American Heart Rhythm Society.
The SMART-AF trial showed that 69% of 172 patients had no atrial fibrillation, atrial flutter or other tachyarrhythmia at 1 year of ablation. This ratio increases when the operator maintains contact for at least 80% of the time. Dr. Andrea Natale, one of the principal investigators at the Arrhythmia Institute at St. David's Medical Center in Texas, reported that exposure was associated with the quality of lesion ablation.
The safety of the catheter has been confirmed, with a 7-day adverse event rate of 9.9%, which is lower than 16.6% of historical data.
The catheter's real-time feedback features allow clinicians to sense contact forces during surgery, thereby more ablating diseased tissue, achieving better clinical outcomes, and minimizing the risk of tissue damage.


Source: China Medical Technology Network

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