FDA Panel Set to Evaluate CryoCor’s Cryoablation System
April 10, 2007 — CryoCor Inc., a medical device company focused on the treatment of cardiac arrhythmias, has announced it was informed by the FDA that the agency will convene an Advisory Panel meeting to review CryoCor's pre-market approval application, or PMA, for the treatment of atrial flutter. The Advisory Panel meeting is expected to be held in June or July 2007, and a decision from the FDA on CryoCor's PMA is expected in August 2007.
CryoCor reported that the chronic effectiveness of its cryoablation system, based upon a strict expert core lab analysis completed by an independent electrophysiologist, was statistically computed to be above 80 percent. An additional analysis performed utilizing a clinical assessment that CryoCor believes is comparable to the analysis from published literature demonstrates a chronic effectiveness above 90 percent.
CryoCor believes the use of an expert core lab to determine the chronic effectiveness is a more rigorous evaluation than has been completed in other clinical trials for the treatment of atrial flutter.
"I am happy to participate in the presentation of clinical data on behalf of CryoCor at the upcoming Advisory Panel meeting,” said Gregory Feld, M.D., principal investigator for CryoCor's atrial flutter pivotal trial. “I believe it is important to make this new medical technology available as an alternative to existing treatments, as there are specific atrial flutter patients that would benefit from cryoablation therapy."
For more information visit www.cryocor.com