Cook's REFORM Trial Completes Enrollment
June 15, 2009—Cook Medical (Bloomington, IN) announced the completion of patient enrollment in the REFORM clinical trial of its Formula balloon-expandable stent for treating renal artery stenosis. The trial is designed to evaluate the safety and effectiveness of the Formula device for treating renal artery atherosclerosis against well-established performance data. Investigators enrolled 100 patients at seven sites in the United States. Initial clinical results on the trial's endpoint of revascularization of the target lesion to perfuse the kidney measured at 9 months postprocedure are expected to be available in the second quarter of 2010. US Food and Drug Administration regulatory submissions are expected to be made based on those data, stated the company.
"The REFORM trial completed enrollment in record time considering the small number of select investigative sites invited to participate in the trial," commented REFORM Principal Investigator Robert Bersin, MD. "The speed with which enrollment was completed speaks to the comfort the operators, including myself, have with the performance of this dedicated renal stent platform. The acute outcomes have been nothing but superb. The trial is now in follow-up, and we are confident that long-term patient outcomes will be as good as the acute outcomes we observed."