IRELAND – Medtronic has announced that its Freezor and Freezor Xtra cardiac cryoablation catheters have received expanded FDA approval for pediatric atrioventricular nodal reentrant tachycardia (AVRNT).
AVNRT is the most common type of supraventricular tachycardia and is characterized by a potentially fatal abnormal heart rhythm.
According to Medtronic, more than a third of AVRNT cases are in pediatrics, or children under the age of 18.
If left untreated, the heart disorder can cause a very rapid heart rhythm and impair the heart’s ability to pump normally.
The Freezor and Freezor Xtra catheters were created by Medtronic as flexible, single-use devices that freeze cardiac tissue and block unnecessary electrical signals in the heart.
According to Medtronic, these are the first ablation catheters to gain approval for treating pediatric AVNRT.
The expanded approval, which includes children aged 2 and up, is based on findings from Medtronic’s ICY-AVNRT trial as well as multiple pediatric randomized, multi-center studies that demonstrated the safety and efficacy of treating AVNRT with the Freezor and Freezor Xtra cryoablation catheters.
The focal cryoablation therapy has treated over 140,000 patients in 67 countries.
According to one study, the acute procedural success rate was 95%, with no reports of permanent pacemaker placement due to complete atrioventricular block.
Sixteen additional studies, as well as a larger body of evidence, demonstrated high efficacy rates and low adverse events, the company said in a press release.
Bryan Cannon, professor of pediatrics and past president of the Pediatric & Congenital Electrophysiology Society (PACES), said: “There are very few devices approved to treat medically complex pediatric cardiology patients today.”
“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 became commercially available in the U.S. in 2003 for use in adults with AVNRT. The Freezor Xtra cardiac cryoablation catheter followed in 2016.
In other related news, Abbott last month also received FDA approval for its new cardiac mapping solution, which provides users with 3D representations of the entire heart of the patient.
The EnSite X EP System with EnSite Omnipolar Technology was created with cardiac arrhythmias like atrial fibrillation (AFib) in mind.
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