June 11, 2009 - Cook Medical announced today the completion of patient enrollment in its REFORM clinical trial, designed to evaluate Cook’s advanced Formula Balloon Expandable Stent for the treatment of renal artery stenosis.
The trial, designed to evaluate the safety and effectiveness of the Formula Balloon Expandable Stent for the treatment of renal artery atherosclerosis against well-established performance data, enrolled 100 patients at seven investigative sites throughout the U.S. Initial clinical results on the trial’s endpoint of revascularization of the target lesion to perfuse the kidney measured at nine months post-procedure are expected to be available in Q2 of 2010, and an FDA regulatory submission is expected to be made based on those data.
The extremely low profile of the Formula Balloon Expandable Stent is lower than many cobalt chromium stent platforms. In addition, the stent does not shorten upon expansion, which can potentially improve accurate placement across the diseased lesion.
The Formula Balloon Expandable Stent is an investigational device and is not currently approved for treatment of renal artery stenosis in the United States.
For more information: www.cookmedical.com