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ensoETM® System
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ensoETM® System
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Esophageal protection through proactive cooling during RF cardiac ablation*
Ordering Information
The following results are from studies comparing ensoETM® system to luminal esophageal temperature (LET) monitoring:1,2,7
- 83.4% relative reduction of thermal injury with the ensoETM® system7
- 100% reduction of severe esophageal lesions with the ensoETM® system (per-protocol)1
In a retrospective review of 25,186 RF ablations across 30 hospitals, 14,224 ensoETM system patients were compared to 10,962 LET monitoring patients:2
- Statistically significant reduction in atrioesophageal fistula (AEF) rate from 0.146% with LET to 0% after adoption of the ensoETM® system
- 0 AEFs identified in the 14,224 patients treated with the ensoETM® system
Note: These results may not be fully representative. Limitations include but are not limited to: (1) assumed, not controlled device usage (2) no follow-up was performed, and (3) no linkage to specific patients. See article for additional limitations and details.
Just Cool It
- Freedom from temperature alarms and stoppages associated with LET monitoring4
- 14% absolute increase in freedom from atrial arrhythmia at one year3
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ensoETM® system eliminates the temperature alarms and stoppages associated with LET probes4
Because the ensoETM® system removes the need for LET probes, it eliminates the need to pause for alarms or reposition a temperature sensor, resulting in:
- A reduction in mean procedure time by 36–60 minutes5,6
- A 43% relative mean increase in lab throughput in a study of 2,498 PVIs comparing ensoETM (n=1,472) to LET with added esophageal deviation when deemed necessary (n=1,026)8
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Proactive Esophageal Cooling
• Circulates water to cool the esophagus
• Closed-loop system
• Placed by anesthesia
• Central lumen provides gastric suction if needed
Resource Centre
Find the information you need as you browse through helpful, on-demand information to aid in your understanding of our vascular closure solutions.
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Instructions for Use (ECD01)
The ensoETM® thermal regulating device is intended to connect to a Gaymar Medi-Therm® III or Stryker Altrix™ to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
Instructions for Use (ECD02)
The ensoETM® thermal regulating device is intended to connect to a Gentherm Blanketrol® II/III to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
Instructions for Use (ECD02)
The ensoETM® thermal regulating device is intended to connect to a Gentherm Blanketrol® II/III to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
Product Animation Video
Learn more about how the ensoETM® system provides esophageal protection through proactive cooling during radiofrequency (RF) cardiac ablation.*
* For ensoETM models ECD01-A and ECD02-A. Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, adverse events and instructions for use.
† Results are from studies comparing the ensoETM system to luminal esophageal temperature (LET) monitoring.
1. Leung, L. W. M., Bajpai, A., Zuberi, Z., Li, A., Norman, M., Kaba, R. A., Akhtar, Z., Evranos, B., Gonna, H., Harding, I., Sohal, M., Al-Subaie, N., Louis-Auguste, J., Hayat, J., Gallagher, M. M. (2021). Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study. EP Europace, 23(2), 205–215. https://doi.org/10.1093/europace/euaa276
2. Sanchez, J, Woods, C, Zagrodzky, J. et al. Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation. J Am Coll Cardiol EP. 2023 Dec, 9 (12)2558–2570. DOI: https://doi.org/10.1016/j.jacep.2023.08.022
3. Joseph, C., Nazari, J., Zagrodzky, J. et al. Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation. J Interv Card Electrophysiol 66, 1621–1629 (2023). https://doi.org/10.1007/s10840-023-01474-3
4. Cooper, J., Joseph, C., Zagrodzky, J., et al. (2022). Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update. Expert Review of Medical Devices, 19(12),949–957. https://doi.org/10.1080/17434440.2022.2150930
5. Joseph C, et al. Impact of active esophageal cooling on catheter ablation procedure times across five healthcare systems. Euro Heart J 2023;44 (Suppl 2).
6. Joseph C, et al. Procedural time reduction associated with active esophageal cooling during pulmonary vein isolation. J Interv Card Electophysiol 2022; (65):617-622. https://doi.org/10.1007/s10840-022-01204-1.7.
7. Leung, L. W. M., Ahkhtar Z, Elbatran A.I., Bajpai A., Li A., Norman M., Kaba R., Sohal, M., Zuberi Z., Gallagher M.M. on behalf of the IMPACT study group. Effect of esophageal cooling on ablation lesion formation in the left atrium; Insights from ablation index data in the IMPACT trial and clinical outcomes. J Cardiovasc Electrophysiol 2022;22:2546-2557. https://DOI:10.1111/jce.15717
8. Zagrodzky W, Cooper J, Joseph C, et al. Association between proactive esophageal cooling and increased lab throughput. J Cardiovasc Electrophysiol. 2024; 1-6. doi: https://doi.org/10.1111/jce.16263
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