A Medical Device Daily

CryoCor (San Diego), a developer of treatments of cardiac arrhythmias, reported that, based upon its July 26 meeting with FDA officials, it plans to file an amendment to its pre-market approval (PMA) application for the treatment of atrial flutter (AFL) in 3Q06.

CryoCor previously reported receiving a letter from the FDA informing it that its Cardiac Cryoablation System was not approvable for the treatment of AFL because the data presented did not meet “chronic efficacy” criteria.

Since then, CryoCor said it retained expert physicians in the field of electrophysiology to review the data for patients treated in its pivotal trial to determine the success of each procedure. It also engaged external consultants to assist in re-evaluating the data and advise it on a potential amendment to its PMA, based on additional information.

CryoCor presented the re-evaluation of the AFL data to the FDA but said there is no assurance that the agency will determine that the data presented in the amendment meets the criteria or that the amended PMA will be approved.

Ed Brennan, president/CEO of CryoCor, said, “We felt that the agency was receptive to our plans to amend the PMA. We discussed both the content and structure of the amendment,” and added that it will be submitted “in the near term.”

CryoCor's Cardiac Cryoablation System is designed to treat cardiac arrhythmias through the use of cryoenergy to destroy targeted cardiac tissue. The system has been approved in Europe for the treatment of both atrial fibrillation (AF) and AFL since 2002. In the U.S., CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the Cryoablation System for the treatment of AF.