Medtronic today announced that it received FDA expanded approval for its Freezor and Freezor Xtra cardiac cryoablation catheters for pediatric atrioventricular nodal reentrant tachycardia (AVRNT).
AVNRT is the most common form of supraventricular tachycardia and involves a life-threatening abnormal heart rhythm. More than a third of AVRNY cases are in pediatrics or children under the age of 18, Medtronic reports. The heart disorder can cause a very rapid heart rhythm and, if left untreated, can affect the heart’s ability to pump normally.
Medtronic designed the Freezor and Freezor Xtra catheters as flexible, single-use devices that freeze cardiac tissue and block unnecessary electrical signals in the heart. The focal cryoablation therapy has treated more than 140,000 patients across 67 countries, according to the company.
The expanded approval — which covers kids 2 and over — is supported by results from Medtronic’s ICY-AVNRT trial and multiple pediatric randomized, multi-center studies that demonstrated the safety and effectiveness of treating AVNRT using the Freezor and Freezor Xtra cryoablation catheters. One study reported acute procedural success of 95% with no reports of permanent pacemaker due to complete AV block. Sixteen other studies and a larger body of evidence showed high efficacy rates and low adverse events.
“There are very few devices approved to treat medically complex pediatric cardiology patients today,” Bryan Cannon, professor of pediatrics and past president of the Pediatric & Congenital Electrophysiology Society (PACES), said in a news release. “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 Freezor cardiac cryoablation catheter was made commercially available in the U.S. in 2003 for use in adults with AVNRT. The Freezor Xtra cardiac cryoablation catheter followed 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,” Rebecca Seidel, president of the cardiac ablation solutions business at Medtronic, said. “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.”