A Medical Device Daily

CryoCor (San Diego) reported the completion of enrollment of its pivotal clinical study for the treatment of atrial fibrillation.

Helen Barold, MD, chief medical officer of CryoCor, said, “I am very pleased with the progress we have made with this study and look forward to fully analyzing the data. We continue to see an excellent safety profile for our cryoablation device and expect to file a PMA in late 2008. At this point we will begin our non-randomized continued access protocol in which patients will be enrolled into the ablation arm.”

Ed Brennan, PhD, CEO of CryoCor, said, “This is a major milestone for CryoCor, being the first company to complete enrollment in a randomized pivotal study for the use of ablation for the treatment of atrial fibrillation. Completion of enrollment confirms our lead over other companies conducting atrial fibrillation ablation pivotal trials and brings us one step closer to our goal of bringing our product to market for the treatment of atrial fibrillation. With the recent approval of our cryoablation system for the treatment of right atrial flutter, in the fourth quarter, we will begin placing our system at high volume ablation centers across the U.S., familiarizing physicians with our system and establishing our installed base of consoles in anticipation of approval for the treatment of atrial fibrillation in 2009.”

CryoCor has enrolled more than 170 patients in its pivotal clinical study and will complete a 12-month follow up for each patient.

CryoCor focuses on treatment of cardiac arrhythmias.