FDA Allows CryoCath to Begin IDE Study for AF Treatment
CryoCath Technologies has received clearance from the FDA to initiate an investigational device exemption (IDE) study for the treatment of atrial fibrillation (AF).
The study will see the use of two CryoCath catheters: Arctic Front to treat AF and Freezor MAX to treat atrial flutter when concomitant to AF. The initial stage of this trial will treat approximately 25 AF patients at three U.S. centers, with enrollment completed by the end of the second quarter of calendar 2005. Initial three-month follow-up data is expected to be available in the fourth quarter of calendar 2005.
The trial's endpoints will be safety (stenosis) and efficacy (AF free with or without drugs). CryoCath intends to use the data from this initial stage of the trial and ongoing European data to apply for U.S. regulatory approval to commence the pivotal stage of this IDE study for the treatment of AF.