FDAnews Device Daily Bulletin

Medtronic’s Cryoballoon Comparable to ThermoCool

April 6, 2016

Medtronic’s Artic Front Cryoballoon catheter family met a noninferiority endpoint versus the ThermoCool line of radiofrequency ablation catheters to treat symptomatic paroxysmal atrial fibrillation, the company announced Monday.

In the FIRE AND ICE study, the device reached its noninferiority endpoint in reducing arrhythmia recurrence and need for antiarrhythmic drug therapy and/or re-ablation. Further, the device met its primary safety endpoint.  

The study results were presented at the American College of Cardiology’s 65th Annual Scientific Sessions in Washington, D.C., as well as published in The New England Journal of Medicine. — Anisa Jibrell