FDA grants expanded indication to cryoablation catheters for pediatric arrhythmia
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Medtronic announced it received expanded indication for its cardiac cryoablation focal catheters from the FDA for the treatment of pediatric atrioventricular nodal reentrant tachycardia.
The cryoablation catheters (Freezor and Freezor Xtra) are flexible, single-use devices used to freeze cardiac tissue and block unnecessary electrical signals within the heart, according to a press release from the company.
The expanded approval was supported by results from the ICY-AVNRT and multiple pediatric randomized trials. According to the release, the results of ICY-AVNRT demonstrated a procedural success of 95% and no reports of permanent pacemaker due to complete AV block.
"There are very few devices approved to treat medically complex pediatric cardiology patients today," Bryan C. Cannon, MD, pediatric cardiologist at Mayo Clinic and past president of the Pediatric and Congenital Electrophysiology Society, said in the 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."
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