February 16, 2017 — Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter for treating patients with atrioventricular nodal re-entrant tachycardia (AVNRT), a life- threatening abnormal heart rhythm.
The Freezor Xtra Catheter is a flexible, single-use device used to freeze cardiac tissue and block unnecessary electrical signals within the heart.
AVNRT is an abnormal heart rhythm, or arrhythmia; approximately 319,000 people live with AVNRT and more than 49,000 people are diagnosed each year.1, 2
“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,” said Peter Wells, M.D., heart rhythm doctor at Baylor Heart and Vascular Hospital, Dallas, and principal investigator of the Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia (ICY-AVNRT) clinical trial.
The expanded indication is supported by data from 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 United States and Canada, the study showed freedom from AVNRT was 92.6 percent at six months post-procedure. All of the safety endpoints were met, with no primary safety events related to the Freezor Xtra Catheter.
For more information: www.medtronic.com