* Success defined as freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months post-procedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range ≥85% of time, success was increased by 21% to 88% (≥85%: n = 32; <85%: n = 73).

1. Carlos A Morillo et al. 2017. Atrial fibrillation: the current epidemic. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5460066/. Accessed August 2019.
2. Hugh Calkins, Gerhard Hindricks, Ricardo Cappato, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter ablation and surgical ablation of atrial fibrillation. 2017.
3. Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG et al. (2016) Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. Bmj 354 i4482.
4. Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology. 2014 Aug 19;64(7):647-56.

The THERMOCOOL SMARTTOUCH^® SF Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF) and for drug refractory recurrent symptomatic persistent AF (continuous AF > 7 days but < 1 year), refractory or intolerant to atleast 1 Class I or III AAD, when used with the CARTO^® 3 System.

As with any medical treatment, individual results may vary. Only a cardiologist or electrophysiologist can determine whether ablation is an appropriate course of treatment. There are potential risks including bleeding, swelling or bruising at the catheter insertion site, and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); heart attack, or death. These risks need to be discussed with your doctor and recovery takes time. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

Caution: US law restricts this device to sale by or on the order of a physician.

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