Cook Medical announced the completion of patient enrollment in its REFORM clinical trial. The REFORM trial is designed to evaluate the safety and effectiveness of the Formula Balloon Expandable Stent for the treatment of renal artery stenosis.
The REFORM trial completed enrollment in record time considering the small number of select investigative sites invited to participate in the trial,” said Robert Bersin, M.D., the trial’s principal investigator and medical director of endovascular services at Seattle Cardiology and Swedish Medical Center. “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.
The REFORM trial enrolled 100 patients at seven investigative sites throughout the US. Initial clinical results are expected to be available in Q2 of 2010. Based on results an FDA regulatory submission is expected to be made.
“Cook has long been a leader in balloon and stent technology in the peripheral arteries, and the enthusiasm seen amongst clinical trial participants using our new Formula stent indicates that we are on the verge of bringing an advanced stenting technology to patients suffering renal artery blockages,” said Rob Lyles, vice president and global business unit leader of Cook Medical’s peripheral intervention division. “We look forward to timely completion of the clinical follow-up on these patients.”
Cook’s Formula Balloon Expandable Stent can be placed accurately across the lesion as it does not shorten upon expansion. It has an extremely low profile that is lower than many cobalt chromium stent platforms.