A Medical Device Daily
CryoCor (San Diego), a company focused on the treatment of cardiac arrhythmias, reiterated earlier this week that it is scheduled to present on June 27 clinical data related to its premarket approval (PMA), for the treatment of atrial flutter (AFL) at an advisory panel meeting.
The advisory panel meeting was convened to advise the FDA on whether or not the chronic effectiveness data in CryoCor's pivotal trial for the treatment of AFL provides a reasonable assurance of effectiveness.
The company said its communications with the FDA have been routine, and it indicated that it is not aware of any other developments or information related to the upcoming panel meeting.
The company received a "not approvable" letter from the FDA in February 2006 (Medical Device Daily, Feb. 6, 2006) for its AFL PMA, because, according to the agency, the data presented did not meet "chronic efficacy" criteria, the criteria the company used in its trial supporting the application.
At the time of the "not approvable" letter, CEO Greg Ayers, indicated that the primary reason for the agency's decision was based on the "subjective" method required for interpreting chronic efficacy.
That turn of events caused the company to amend its PMA filing for the device which is already approved in Europe for the treatment of atrial fibrillation and AFL, which are the two most common forms of heart arrhythmias.
The company also said that enrollment in its atrial fibrillation pivotal trial has continued at the expected pace, the company said and it expects to complete enrollment shortly and needs to enroll only three and eight additional patients to complete enrollment.