Cook Medical has completed patient enrollment in its REFORM clinical trial, officials of Cook Medical reported today. The REFORM trial is designed to evaluate Cook's advanced Formula™ Balloon Expandable Stent for the treatment of renal artery stenosis, a narrowing of the renal artery that can result in hypertension, renal atrophy, and kidney failure if left untreated.
“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, MD, 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 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 through 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 submissions is expected to be made based on those data.
“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 a significant advance in stenting technologies 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 speedy completion of the clinical follow-up on these patients.”
Renal artery disease is a narrowing of the arteries that supply blood to the kidneys. In early stages, plaque comprised of fatty deposits and calcium can collect within these arteries, reducing blood flow to the kidneys and potentially increasing blood pressure. This hypertension, coupled with atherosclerosis, greatly increases stress on the heart and can lead to a stroke. The restriction of blood flow from the renal artery can also decrease the ability of the kidneys to filter and remove the waste and fluids from the body, leading to possible renal insufficiency and kidney failure. Balloon angioplasty has been the treatment method of choice for this condition, but does not always result in permanent reopening of the narrowed blood vessel, prompting investigators to explore whether the use of a mesh-like tube called a stent can result in better long-term patient outcomes.
The Formula Balloon Expandable Stent features an extremely low profile that 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 not currently indicated for renal artery stenosis in the United States.
About Cook Medical:
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com .