Watch the Stay Cool vodcast
You are invited to join expert EPs on their journey into work to learn more about their background, challenges and expertise in cryoballoon ablation. Stay tuned!
Episode 1: Featuring Dr Melanie Gunawardene – Watch Now
Episode 2: Featuring Dr Andreas Rillig – Watch Now
Episode 3: Featuring Prof. Claudio Tondo – Watch now
Subscribe below to be informed when episodes are released.
Single-shot ablation was pioneered by Medtronic back in 2005 when the first cryoballoon ablation catheter received CE Mark. Soon after in 2006, the first electroporation research for cardiac surgery began1. We have a long-standing commitment to advancements in this field – our dedication to you and your patients.
Arctic Front™ Cardiac
Cryoablation Catheter System
- 23+ years clinical experience2
- 2000+ clinical publications3
- 1.4M+ patients treated worldwide4
PulseSelect™ PFA System
- 15 years of electroporation research in cardiac ablation
- 21 preclinical publications5-25
- 1st and safest PFA IDE trial to date26-27
Cryoballoon ablation established as the gold standard of AF ablation.28
PULSED AF was the first PFA IDE trial completed – including both paroxysmal and persistent patients.
Committed to elevating your single-shot procedures even further, with our recently launched innovations.
Nitron CryoConsole™ Cardiac Cryoablation System
- Sterile field operation and quicker reactivity with remote control
- Visualization of previous freeze in same location
PulseSelect™ PFA System
- 0.7% primary safety event rate26-27
- Unique safety features including R-wave gating and phrenic nerve test pulse
FlexCath Contour™ Steerable Sheath
- Shorter tip length option for easier access to RIPV
- 39% greater support during PV occlusion29
FlexCath Cross™ Transseptal Solution
- Zero exchange workflow
- 16.6% reduction in total procedure time*30
*vs. NRG™ transseptal needle
Short learning curve and procedure duration31
Incomparable safety profile
- 0.004% global incidence of AE fistula37, 39
- 0.06% permanent PNI at 12 months38
Fixed electrode spacing to produce predictable, consistent, and contiguous energy delivery.32
20-degree forward tilt to ensure consistent uniform tissue contact.33
Dedication to a diverse patient population
The only single-shot provider…
1. With approved indication beyond paroxysmal AF
*AF type definition from ESC AF Management Guidelines 2020
3. With a wealth of long-term cryoablation evidence in countless patient groups
- 5-year follow up47,48
- Octogenarian patients49,50
- Young patients51
- Heart Failure patients52,53
- Female patients54,55
- Obese patients56,57
- Diabetic patients58,59
The evidence keeps on growing.
References
1
Medtronic data on file. Howard, B; 10892883DOC Dec 2018
2. Medtronic Data on File [Proven Cryo technology: 22+ years experience with Medtronic Cryo Console].
3. Medtronic Data on file [Rapid growth in worldwide adoption FY24]
4. Medtronic data on file [Katie Neumeyer, FY24 Patients served, CMR Q1].
5. Verma, et al. “Effects of tissue proximity on cardiac lesion formation using PFA.”
6. Escartin, et al. “Investigating pulsed field (PFA) vs radiofrequency ablation (RFA) lesion characteristics in an in vivo healthy porcine left ventricle using 3D LGE and native T1w MRI”
7. Krahn, et al. “Chronic pulsed field ablation in the porcine LV: dose dependence and correlation with late gadolinium enhancement MRI.”
8. Emami, et al. “Association between lesion size and field strength of pulsed field ablation.”
9. Emami, M. et al. “Feasibility and safety of electroporation using pulsed field ablation in pulmonary vein isolation.” Heart Rhythm17:5 (2020)
10. Emami M. et al. “Extent of myocardial injury and collateral damage following electroporation using pulsed field ablation determined via intraprocedural monitoring.” Heart Rhythm17:5 (2020)
11. Emami M. et al. “Effective dose of pulsed field ablation to achieve pulmonary vein isolation.” Heart Rhythm17:5 (2020)
12. Verma, A., et al. “Safety and Efficacy of Pulsed Field Ablation in Comparison to Radiofrequency Ablation in a Swine Model.” Heart Rhythm
13. Onal B., et al. “Non-thermal assessment via temperature measurements at tissue interface during intracardiac pulsed field ablation.” Heart Rhythm 2019 16:5 (377-378)
14. Verma, A., et al. “1207 Pulsed Field Ablation: Acute and Chronic Safety and Lesion Efficacy.”European Heart Journal40.Supplement_1 (2019): ehz748-0037.
15. Verma, A., et al. “P6611 Pulsed field ablation-feasibility, safety and comparison to radiofrequency.”European Heart Journal39.suppl_1 (2018): ehy566-P6611.
16. Howard, Brian T., et al. “Pulsed Field Ablation Reduces Pulmonary Vein Stenosis Risk: An Advanced Model for Assessment of PV Stenosis.”Circulation138.Suppl_1 (2018): A16516-A16516.
17. Mattison, Lars, et al. “Effect of Contact Force on Pulsed Field Ablation Lesions in Porcine Cardiac Tissue.” Journal of Cardiovascular Electrophysiology (2023).
18. Howard, Brian, et al. “Effects of Electrode-Tissue Proximity on Cardiac Lesion Formation Using Pulsed Field Ablation.” Circulation: Arrhythmia and Electrophysiology 15.10 (2022): e011110.
19. Howard, Brian, et al. “Characterization of Phrenic Nerve Response to Pulsed Field Ablation.” Circulation: Arrhythmia and Electrophysiology (2022): CIRCEP-121.
20. Di Biase, Luigi, et al. “Pulsed field catheter ablation in atrial fibrillation.” Trends in cardiovascular medicine (2021).
21. Stewart, Mark T., et al. “Safety and chronic lesion characterization of pulsed field ablation in a Porcine model.” Journal of Cardiovascular Electrophysiology 32.4 (2021): 958-969
22. Howard, Brian, et al. “Reduction in Pulmonary Vein Stenosis and Collateral Damage with Pulsed Field Ablation Compared to Radiofrequency Ablation in a Canine Model.” Circulation: Arrhythmia and Electrophysiology (2020).
23. Haines, David E., and Christopher J. Bradley. “The Promise of Pulsed Field Ablation.” EP Digest
24. Bradley, Christopher J., and David E. Haines. “Pulsed Field Ablation for Pulmonary Vein Isolation in the Treatment of Atrial Fibrillation.” Journal of Cardiovascular Electrophysiology(2020).
25. Stewart, Mark T., et al. “Intracardiac pulsed field ablation: proof of feasibility in a chronic porcine model.”Heart rhythm16.5 (2019): 754-764.
26. Verma A, et al. Circulation. 2023;147:1422-1432.
27. Verma A, et al. Circ Arrhythm Electrophysiol. 2022;15:e010168.
28. Kirchhof P, et al. European Heart Journal (2016) 37,2893-2962. (ESC guidelines for the management of atrial fibrillation).
29. Medtronic data on file. 2023.
30. Yap SC, et al. J Interv Card Electrophysiol. 2022;65:527-534.
31. Velagić V, et al, Learning curve using the second-generation cryoballoon ablation. Italian Federation of Cardiology 2016.
32. Howard B, Verma A, Tzou WS, et al. Effects of Electrode-Tissue Proximity on Cardiac Lesion Formation Using Pulsed Field Ablation. Circ Arrhythm Electrophysiol. 2022;15(10):e011110.
33. Based on internal document PVAC Gold SNO Request_040113.pptx
34. Heeger CH, et al. Heart Rhythm. 2017;14(8):1111-1118.
35. Mugnai et al. Int J Cardiol Heart Vasc. 2022 Apr 27;40:101040.
36. Bordignon et al. Europace. 2021 Jun 7;23(6):868-877.
37. Piccini JP, et al. Heart Rhythm. O2 2020;1:173-179
38. Heeger et al. Circ Arrhythm Electrophysiol. 2022; Jan;15(1) e010516.
39. Tilz, Roland Richard et al. European heart journal vol. 44,27 (2023): 2458-2469. doi:10.1093/eurheartj/ehad250
40. Wazni OM, Dandamudi G, Sood N, et al; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021; 384(4): 316-324.
41. Andrade JG, Wells GA, Deyell MW, et al; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021; 384(4): 305-315.
42. Kuniss M, Pavlovic N, Velagic V, et al; Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021; 23(7): 1033-1041.
43. Andrade et al. Europace. 2023 May 24;25(Suppl 1):euad122.688.
44. Goette et al. European Heart Journal, Volume 44, Issue Supplement_2, November 2023, ehad655.3029
45. Wazni O et al. Heart Rhythm O2. 2023 Jul 27;4(9):528-537.
46. Andrade et al. Can J Cardiol. 2024 Apr;40(4):576-584.
47. Heeger et al. Int J Cardiol. 2020 Aug 1;312:73-80.
48. Kuniss et al. J Cardiovasc Electrophysiol. 2018 Nov;29(11):1500-1507.
49. Cecchini F, Mugnai G, Iacopino S, et al. Safety and long-term efficacy of cryoballoon ablation for atrial fibrillation in octogenarians: a multicenter experience. J Interv Card Electrophysiol. (2022) 65:2(559-571).
50. Akhtar T.; Berger R.; Marine J.E.; Daimee U.A.; Calkins H.; Spragg D. Cryoballoon Ablation of Atrial Fibrillation in Octogenarians. Arrhythmia and Electrophysiology Review (2020) 9:2 (104-108).
51. Bertaglia E, Iacopino S, Verlato R, Arena G, Pieragnoli P, Tondo C, Molon G, Manfrin M, Perego GB, Rovaris G, Rivezzi F, Mantica M, Startari U, Sciarra L. Safety and efficacy of cryoablation for atrial fibrillation in young patients: A multicenter experience in the 1STOP project. Clin Cardiol. (2023) 46:2 (142-150).
52. Zhang J.; Ren Z.; Wang S.; Zhang J.; Yang H.; Zheng Y.; Meng W.; Zhao D.; Xu Y. Efficacy and safety of cryoballoon ablation for Chinese patients over 75 years old: A comparison with a younger cohort. Journal of Cardiovascular Electrophysiology (2019) 30:12 (2734-2742).
53. Chen C, Cheng K, Gao X, Zou T, Pang Y, Ling Y, Xu Y, Xu Y, Chen Q, Zhu W, Ge J. Cryoballoon ablation for atrial brillation in patients with heart failure with mildly reduced and preserved ejection fraction. ESC Heart Fail. (2023) 10:1 (518-531).
54. Yanagisawa S, Suzuki H, Kanzaki Y, et al. Efficacy and feasibility of cryoballoon ablation for atrial brillation in patients with heart failure: A large-scale multicenter study. J Cardiovasc Electrophysiol. (2022) 33:12 (2447-2464).
55. Yao R.J.R.; Macle L.; Deyell M.W.; Tang L.; Hawkins N.M.; Sedlak T.; Nault I.; Verma A.; Khairy P.;Andrade J.G. Impact of Female Sex on Clinical Presentation and Ablation Outcomes in the CIRCA-DOSE Study. JACC: Clinical Electrophysiology (2020) 6:8 (945-954).
56. Wolfes J, Hoppe D, Ellermann C, Willy K, Rath B, Leitz P, Güner F, Köbe J, Lange PS, Eckardt L, Frommeyer G. Pulmonary Vein Isolation in Obese Compared to Non-Obese Patients: Real-Life Experience from a Large Tertiary Center. J Cardiovasc Dev Dis. (2022) 9:8 (275).
57. Malaspina D.; Brasca F.; Iacopino S.; Arena G.; Molon G.; Pieragnoli P.; Tondo C.; Manfrin M.; Rovaris G.; Verlato R.; Dello Russo A.; Startari U.; Sgarito G.; Perego G.B. Cryoablation for pulmonary veins isolation in obese patients with atrial fibrillation compared to nonobese patients. PACE - Pacing and Clinical Electrophysiology (2021) 44:2 (306-317).
58. Guckel D.; Isgandarova K.; Bergau L.; Piran M.; El Hamriti M.; Imnadze G.; Braun M.; Khalaph M.;Fink T.; Sciacca V.; Nölker G.; Lee-Barkey Y.-H.; Tschöpe D.; Sommer P.; Sohns C. The effect of diabetes mellitus on the recurrence of atrial fibrillation after ablation. J Clin Med. (2021)10:21 (4863).
59. Abdin A.; Heeger C.H.; Yalin K.; Santoro F.; Brunetti N.D.; Fink T.; Liosis S.; Brueggemann B.;Keelani A.; Phan H.-L.; Sano M.; Sciacca V.; Lyan E.; An D.; Meyer-Saraei R.; Ouyang F.; Kuck K.-H.; Eitel C.; Vogler J.; Tilz R.R. Safety and efficacy of cryoballoon ablation for the treatment of atrial fibrillation in diabetic patients. J Atr Fibrillation. 2020 Apr 30;12(6):2285.
60. Reddy VY et al; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671.
DISCLAIMER
The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s). Please note that the intended use of a product may vary depending on geographical approvals.
See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI. If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.
Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
Medtronic products placed on European markets bear the CE mark and the UKCA mark (if applicable). For any further information, contact your local Medtronic representative.
© 2024 Medtronic. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic.
™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.