The expanded approval for both catheters, which are designed to freeze cardiac tissue and block unnecessary electrical signals within the heart, is based on data from ICY-AVNRT and multiple paediatric randomised and multi-centre studies, which have shown their safety and efficacy in the treatment of AVNRT
The world headquarters of Medtronic in Fridley, Minnesota, US. (Credit: Bobak Ha'Eri)
Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Freezor and Freezor Xtra cardiac cryoablation focal catheters for the treatment of paediatric atrioventricular nodal reentrant tachycardia (AVNRT).
AVNRT, which is the common form of supraventricular tachycardia (SVT), is said to be a life-threatening abnormal heart rhythm with 89,000 cases per annum.
Medtronic stated that catheter ablation is a first-line therapy to treat AVNRT.
The flexible and single-use Freezor and Freezor Xtra devices are designed to freeze cardiac tissue and block unnecessary electrical signals within the heart.
The expanded approval of both catheters was based on data from ICY-AVNRT and multiple paediatric randomised and multi-centre studies, which have shown the safety and efficacy of both catheters in the treatment of AVNRT.
Medtronic cardiovascular portfolio’s cardiac ablation solutions business president Rebecca Seidel said: “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.
“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.”
Designed to provide safe and effective focal cryoablation therapy, the Freezor family devices has already been used to treat over 140,000 patients across 67 countries.
In 2003, the company first launched the Freezor cardiac cryoablation catheter to treat adult patients with AVNRT. In 2016, the firm launched the Freezor Xtra cardiac cryoablation catheter.
The Freezor family of cryoablation catheters also consist of Freezor MAX cardiac cryoablation catheter, which secured approval for use in combination with the Arctic Front advance cryoballoon to treat atrial fibrillation (AF).
In January this year, the company secured approval from the FDA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator to treat chronic pain associated with diabetic peripheral neuropathy (DPN).