The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Freezor and Freezor Xtra Cardiac Cryoablation Catheters

These ablation catheters were approved to treat the growing prevalence of pediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT).

AVNRT is the most common form of supraventricular tachycardia (SVT), and is a life-threatening abnormal heart rhythm, with 89,000 cases each year and growing. Nearly 35% of AVNRT cases occur in pediatrics, or, children under the age of 18. 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.

Catheter ablation is a first-line therapy for treatment of AVNRT. The Freezor and Freezor Xtra Catheters are flexible, single-use devices used to freeze cardiac tissue and block unnecessary electrical signals within the heart. The Freezor family enables focal cryoablation therapy and has treated more than 140,000 patients across 67 countries. 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.

“There are very few devices approved to treat medically complex pediatric cardiology patients today,” says Bryan C. Cannon, MD, professor of pediatrics and past president of the Pediatric & Congenital Electrophysiology Society (PACES). “With an FDA indication expansion, the Freezor and Freezor Xtra cardiac cryoablation catheters allow even the youngest of cardiology patients access to a safe, life-enhancing technology that will help advance cardiac care for AVNRT.”

The indication expansion approval is supported by results from ICY-AVNRT and multiple pediatric randomized, multi-center studies that demonstrated the safety and effectiveness of the treatment of AVNRT using the Freezor and Freezor Xtra cardiac cryoablation catheters. ICY-AVNRT data reported acute procedural success of 95% with no reports of permanent pacemaker due to complete AV block. The larger body of evidence, including a total of sixteen studies, also observed high efficacy rates and low adverse events.

The Freezor cardiac cryoablation catheter was first commercially available in the U.S. for adult use of AVNRT in 2003, followed by the Freezor Xtra cardiac cryoablation catheter in 2016. 

“We’re proud of our work with PACES and FDA in this first-of-its-kind, multi-stakeholder initiative to address a critical patient population,” says Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “The shared commitment to collaborate and grow this therapy’s unique position to treat AVNRT patients demonstrates our confidence in the proven safety and efficacy of our cryoablation technology.”