Medtronic bags US FDA approval for Freezor and Freezor Xtra Cardiac Cryoablation catheters

The Freezor and Freezor Xtra Catheters are flexible, single-use devices

Medtronic announced that the Freezor and Freezor Xtra Cardiac Cryoablation Catheters are approved by the US Food and Drug Administration (FDA) and are the only ablation catheters approved to treat the growing prevalence of pediatric Atrioventricular Nodal Reentrant Tachycardia (AVNRT).

AVNRT is the most common form of supraventricular tachycardia (SVT), and is a life-threatening abnormal heart rhythm, with 89,000 cases each year and growing. Nearly 35 per cent of AVNRT cases occur in paediatrics, or, children under the age of 18. Due to an abnormal circuit within the heart’s conduction system, AVNRT causes a very rapid heart rhythm, and if left untreated, can affect the heart’s ability to pump normally, leading to palpitations, lightheadedness, and syncope.

Catheter ablation is first-line therapy for the treatment of AVNRT. The Freezor and Freezor Xtra Catheters are flexible, single-use devices used to freeze cardiac tissue and block unnecessary electrical signals within the heart. The Freezor family enables safe and effective focal cryoablation therapy and has treated more than 140,000 patients across 67 countries. Cryoablation can reduce the risk of permanent AV block, a complication of AVNRT procedures performed with radiofrequency (RF) ablations that results in the partial or complete interruption of the heart’s electrical signals, which dangerously disrupts heart rhythm.

The Freezor cardiac cryoablation catheter was first commercially available in the US for adult use of AVNRT in 2003, followed by the Freezor Xtra cardiac cryoablation catheter in 2016. The Freezor family of cryoablation catheters also includes the Freezor MAX cardiac cryoablation catheter, which is approved for use in conjunction with the Arctic Front Advance cryoballoon for the treatment of atrial fibrillation (AF).

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.