US FDA approves expanded indication for Medtronic Freezor Xtra cryoablation catheter

Freezor Xtra cryoablation catheter

The US Food and Drug Administration (FDA) has approved Medtronic’s Freezor Xtra cryoablation catheter for treating patients with atrioventricular nodal re-entrant tachycardia (AVNRT). The Freezor Xtra catheter is a flexible, single-use device used to freeze cardiac tissue and block unnecessary electrical signals within the heart.

“The expanded indication for this catheter will allow more patients to benefit from a safe and effective therapy that can prevent heart racing, and allow them to get back to their normal activities,” says Peter Wells heart rhythm doctor at Baylor Heart and Vascular Hospital, Dallas, USA, and principal investigator of the ICY-AVNRT clinical trial.

The expanded indication is supported by data from the Intracardiac Cryoablation for Atrioventricular Nodal Reentrant Tachycardia (ICY-AVNRT) clinical study, which demonstrated safety and effectiveness of the Freezor Xtra catheter for the treatment of patients with AVNRT. With 397 enrolled patients in 34 clinical trial sites across the USA and Canada, the study found freedom from AVNRT at 92.6% at six months post-procedure. All of the safety endpoints were met, with no primary safety events related to the catheter.