* The open-platform feature of the EnSite Precision™ cardiac mapping system allows for use of almost any catheter, thus offering superior flexibility as compared to the CARTO‡ system by Biosense Webster, which limits use to Biosense Webster catheters only.
**In an independent head-to-head bench test comparison with the ThermoCool‡ SmartTouch‡ SF catheter, TactiCath Quartz™ contact force ablation catheter showed higher accuracy in both axial (perpendicular) and parallel (lateral) orientations.13
***FlexAbility™ ablation catheter, Sensor Enabled™, uses the same flexible tip as the FlexAbility™ ablation catheter, which has demonstrated equivalent performance in bench and pre-clinical testing to the tip used in Therapy™ Cool Flex™ ablation catheter.
**** The TactiCath™ contact force ablation catheter, Sensor Enabled™ is an update to the TactiCath™ contact force catheter family using the FlexAbility™ catheter family platform handle and shaft and a tip and force sensor derived from the TactiCath™ Quartz catheter. TactiCath™ and TactiCath™ Quartz contact force ablation catheter clinical data are applicable to the TactiCath™ ablation catheter, Sensor Enabled as mechanical/function testing and preclinical studies have demonstrated equivalent performance and safety profile. See St. Jude Medical, data on file, Report 90195941.
† Effortless is based on comparison of the TactiCath™ contact force ablation catheter, Sensor Enabled™ to the TactiCath™ contact force ablation catheter from physician feedback on catheter handling performance between the two catheters during preclinical and bench testing comparing the two catheters with respect to torque response and actuation force.
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2. Abbott. Report on file. 90262900.
3. Abbott. Report on file. 90355919.
4. Abbott. Report on file. 90280703.
5. Peichl P, Kautzner J. Advances in irrigated tip catheter technology for treatment of cardiac arrhythmias. Recent Patents on Cardiovascular Drug Discovery: 8(1); 10-16. https://dx.doi.org/10.2174/1574890111308010003
6. Abbott. Data on File. Report 90122753. Based on Therapy™ Cool Flex™ ablation catheter tip.
7. Winterfield, J. R., Jensen, J., Gilbert, T., Marchlinski, F., Natale, A., Packer, D., . . . Wilber, D. J. (2016). Lesion size and safety comparison between the Novel flex tip on the FlexAbility ablation catheter and the solid tips on the ThermoCool and ThermoCool SF ablation catheters. Journal of Cardiovascular Electrophysiology, 27(1), 102-109. https://doi.org/10.1111/jce.12835
8. Abbott. Report on file. 891607-R
9. Abbott. Data on file. Report 90058001.
10. Ptaszek LM, Moon B, Rozen G, Mahapatra S, Mansour M. Novel automated point collection software facilitates rapid high-density electroanatomic mapping with multiple catheter types. J Cardiovasc Electrophysiol (2018): 29; 186-195. https://dx.doi.org/10.1111/jce.13368
11. Neuzil P, Reddy VY, Kautzner J, et al. Electrical reconnection after PVI is contingent on contact force during initial treatment results from the EFFICAS I study. Circulation Arrhythmia and Electrophysiology, 2013;2(6);327-333. http://dx.doi.org/10.1161/circep.113.000374
12. Kautzner J, Neuzil P, Lambert H, et al. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace, 2015;17,1229–1235. http://dx.doi:10.1093/europace/euv057
13. Bourier F, Deisenofer I, Hessling G, et al. Contact-force sensing electrophysiological catheters: How accurate is the technology? [Abstract PO03-170]. Presentation at HRS 2016, San Francisco, CA, May 4-7,2016. Heart Rhythm. 2016;13(5 Suppl 1): S318-S319.
14. Bourier F, Gianni C, Dare M, et al. Fiberoptic contact-force sensing electrophysiological catheters: how precise is the technology? J Cardiovasc Electrophysiol, 2017;28(1):109-114. http://dx.doi.org/10.1111/jce.13100
15. Abbott. Report of file. 90237452.
16. Yokoyama K, Nakagawa H, Shah DC, Lambert H, Leo G, Aeby N, ... Jackman WM. Novel contact force sensor incorporated in irrigated radiofrequency ablation catheter predicts lesion size and incidence of steam pop and thrombus. Circulation: Arrhythmia and Electrophysiology. 2008;1:354-362.
17. Abbott. Data on File. Report 90247461.
18. Abbott. Data on File. Report 90211752.
19. Abbott. Data on File. Report 90223883.
20. Abbott. Data on File. Report C278453.
21. Abbott. Data on File. Report 90214738.
22. Abbott. Data on File. Report 90253949