The US Food and Drug Administration (FDA) has approved Medtronic’s Freezor and Freezor Xtra cardiac cryoablation focal catheters for the treatment of paediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT).
The cardiac cryoablation catheters are designed to freeze the cardiac tissue and block unnecessary electrical signals in the heart.
Medtronic stated that the two flexible, single-use devices are the first and only ablation catheters approved by the FDA to treat AVNRT.
According to the company, nearly 35% of AVNRT cases are diagnosed in children under the age of 18.
The catheter ablation is considered to be a first-line treatment for AVNRT.
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The regulatory approval for the use of Freezor and Freezor Xtra was based on data obtained from ICY-AVNRT as well as several paediatric multi-centre, randomised trials.
In these trials, the devices showed safety in the treatment of AVNRT.
The cardiac cryoablation catheters demonstrated an acute procedural success rate of 95%, with no reports of permanent pacemaker due to complete atrioventricular block in the ICY-AVNRT trials.
Medtronic cardiac ablation solutions business president Rebecca Seidel said: “We’re proud of our work with the Pediatric and Congenital Electrophysiology Society (PACES) and FDA in this first-of-its-kind, multi-stakeholder initiative to address a critical patient population.
“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.”
The Freezor cardiac cryoablation catheter was commercially available to treat AVNRT in adults in the US for the first time in 2003 while the Freezor Xtra cardiac cryoablation catheter was available in 2016.
Last month, Medtronic’s Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator received FDA approval to treat chronic pain related to diabetic peripheral neuropathy (DPN).