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# FDA Expands Use of Medtronic Freezor Cryoablation
- URL: https://www.fdaweb.com/fda-expands-use-of-medtronic-freezor-cryoablation/
- Published: 2022-02-18T12:00:00.000Z
- Updated: 2026-09-14T17:33:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151203

FDA has granted Medtronic expanded indications for its Freezor and Freezor Xtra Cardiac Cryoablation Focal Catheters for treating pediatric atrioventricular nodal reentrant tachycardia (AVNRT), the most common form of supraventricular tachycardia (SVT). Almost 35% of AVNRT cases occur in children under the age of 18, the company says. “Due to an abnormal circuit within the heart’s conduction system, AVNRT causes a very rapid heart rhythm, and if left untreated, can affect the heart’s ability to pump normally, leading to palpitations, lightheadedness, and syncope.”

The flexible, single-use devices are used to freeze cardiac tissue and block unnecessary electrical signals within the heart, Medtronic says. “Cryoablation can reduce the risk of permanent AV block, a complication of AVNRT procedures performed with radiofrequency (RF) ablations that results in the partial or complete interruption of the heart's electrical signals, which dangerously disrupts heart rhythm,” it says.

The expanded indication was based on data from ICY-AVNRT and multiple pediatric randomized, multi-center studies. “ICY-AVNRT data reported acute procedural success of 95% with no reports of permanent pacemaker due to complete AV block,” Medtronic says.

FDA approved the Freezor device in 2003 for adult use in treating AVNRT, and the Freezor Xtra was approved in 2016.