Alert Indications, Safety, and Warnings

Freezor family of cardiac cryoablation catheters for the treatment of AVNRT (Freezor™ and Freezor™ Xtra) and atrial fibrillation (Freezor™ MAX)

These are single-use catheters designed to ablate cardiac tissue by creating focal lesions. Used in conjunction with the CryoConsole™.

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Alert Indications, Safety, and Warnings

Overview

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Freezor and Freezor Xtra catheters

Restoring life’s rhythm. Big and small.

Freezor and Freezor Xtra cardiac cryoablation catheters freeze the target tissue and block the electrical conduction by creating scar tissue. The catheters are designed to create focal lesions to treat atrial ventricular nodal reentrant tachycardia (AVNRT) for both adult and pediatric* patients.

The Freezor Xtra catheter is also intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias.

* Indicated for patients over two years of age.

Freezor catheter details

  1. Tip length: 4 mm
  2. 2.5 mm
  3. 5 mm
  4. 2.5 mm
  5. Shaft: 7 Fr, 108 cm
Illustration of Freezor cardiac cryoablation catheter with lines and numbers indicating the measurements of the catheter

Freezor Xtra catheter details

  1. Tip length: 6 mm
  2. 2.5 mm
  3. 5 mm
  4. 2.5 mm
  5. Shaft: 7 Fr, 108 cm
Illustration of Freezor Xtra cardiac cryoablation catheter with lines and numbers indicating the measurements of the catheter

Clinical evidence

Proven. Predictable. 

The Freezor and Freezor Xtra catheters are the only FDA-approved ablation catheters for the treatment of AVNRT in both pediatric* and adult patients. Patient outcomes include:

  • 0% of reported AVNRT cases resulted in permanent AV block.1-16
  • 89% quality of life improvement after cryoablation.1-16
  • ≥ 95% acute procedural success from AVNRT.1-16

Download clinical evidence

* Indicated for patients over two years of age.

Testimonial

The first of its kind.

Hear from a pediatric EP to learn more about the Freezor and Freezor Xtra cardiac cryoablation catheters, the first and only FDA-approved devices for the treatment of both pediatric* and adult AVNRT.

* Indicated for patients over two years of age.

Freezor MAX catheter

Look no further.

The Freezor MAX cardiac cryoablation catheter is an adjunctive device used in the endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than six months) to complete pulmonary vein isolation (PVI), if needed. It may also be used for:

  • Gap cryoablation to complete electrical isolation of the pulmonary veins
  • Cryoablation of focal trigger sites
  • Creation of ablation line between the inferior vena cava and the tricuspid valve

Freezor MAX catheter details

  1. Tip length: 8 mm
  2. 3.5 mm
  3. 5 mm
  4. 2 mm
  5. Shaft: 9 Fr, 90 cm
Illustration of Freezor MAX cardiac cryoablation catheter with lines and numbers indicating the measurements of the catheter

Product information

pdf Freezor spec sheet (.pdf)

261KB

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pdf Freezor family sell sheet (.pdf)

365KB

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pdf Freezor Xtra spec sheet (.pdf)

288KB

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pdf Freezor MAX spec sheet (.pdf)

274KB

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pdf Freezor and Freezor Xtra sell sheet  (.pdf)

218KB

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Additional Resources

Related pages

Contact technical support

6:00 a.m.–midnight CT,
Monday–Friday

1-877-464-2796

Email us

Educational resources on Medtronic Academy

Access detailed product information, including spec sheets, videos, and presentations.
Visit Medtronic Academy
*

Indicated for patients over two years of age.

References

1

Wells P, Dubuc M, Klein GJ, et al. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. January 2018;29(1):167–176.

2

Avari JN, Jay KS, Rhee EK. Experience and results during transition from radiofrequency ablation to cryoablation for treatment of pediatric atrioventricular nodal reentrant tachycardia. Pacing Clin Electrophysiol. April 2008;31(4):454-460.

3

Beach C, Beerman L, Mazzocco S, Brooks MM, Arora G. Use of three-dimensional mapping in young patients decreases radiation exposure even without a goal of zero fluoroscopy. Cardiol Young. October 2016;26(7):1297-1302.

4

Chanani NK, Chiesa NA, Dubin AM, Avasarala K, Van Hare GF, Collins KK. Cryoablation for atrioventricular nodal reentrant tachycardia in young patients: predictors of recurrence. Pacing Clin Electrophysiol. September 2008;31(9):1152-1159.

5

Cokkinakis C, Avramidis D, Alexopoulos C, Kirvassilis G, Papagiannis J. Cryoablation of atrioventricular nodal reentrant tachycardia in children and adolescents: improved long-term outcomes with increasing experience. Hellenic J Cardiol. May–June 2013;54(3):186-191.

6

Drago F, Placidi S, Righi D, et al. Cryoablation of AVNRT in children and adolescents: early intervention leads to a better outcome. J Cardiovasc Electrophysiol. April 2014;25(4):398-403.

7

Drago F, Russo MS, Silvetti MS, Santis ADE, Iodice F, Onofrio MTN. Cryoablation of typical atrioventricular nodal reentrant tachycardia in children: six years' experience and follow-up in a single center. Pacing Clin Electrophysiol. April 2010;33(4):475-481.

8

Gist K, Tigges C, Smith G, Clark J. Learning curve for zero-fluoroscopy catheter ablation of AVNRT: early versus late experience. Pacing Clin Electrophysiol. March 2011;34(3):264-268.

9

Papagiannis J, Papadopoulou K, Rammos S, Katritsis D. Cryoablation versus radiofrequency ablation for atrioventricular nodal reentrant tachycardia in children: long-term results. Hellenic J Cardiol. March–April 2010;51(2):122-126.

10

Pieragnoli P, Paoletti Perini A, Checchi L, et al. Cryoablation of typical AVNRT: Younger age and administration of bonus ablation favor long-term success. Heart Rhythm. October 2015;12(10):2125–2131.

11

Qureshi MY, Ratnasamy C, Sokoloski M, Young ML. Low recurrence rate in treating atrioventricular nodal reentrant tachycardia with triple freeze-thaw cycles. Pacing Clin Electrophysiol. March 2013;36(3):279-285.

12

Reents T, Springer B, Ammar S, et al. Long-term follow-up after cryoablation for adolescent atrioventricular nodal reentrant tachycardia: recurrence is not predictable. Europace. November 2012;14(11):1629-1633.

13

Russo MS, Drago F, Silvetti MS, et al. Comparison of cryoablation with 3D mapping versus conventional mapping for the treatment of atrioventricular re-entrant tachycardia and right-sided paraseptal accessory pathways. Cardiol Young. June 2016;26(5):931-940.

14

Scaglione M, Ebrille E, Caponi D, et al. Single center experience of fluoroless AVNRT ablation guided by electroanatomic reconstruction in children and adolescents. Pacing Clin Electrophysiol. December 2013;36(12):1460-1467.

15

Young ML, Niu J. Using coronary sinus ostium as the reference for the slow pathway ablation of atrioventricular nodal reentrant tachycardia in children. J Arrhythm. June 2020;36(4):712-719.

16

Schwagten B, Knops P, Janse P, et al. Long-term follow-up after catheter ablation for atrioventricular nodal reentrant tachycardia: a comparison of cryothermal and radiofrequency energy in a large series of patients. J Interv Card Electrophysiol. January 2011;30(1):55-61.