Study investigators today reported initial data from Cook Medical's REFORM clinical trial that is aimed at assessing the safety and effectiveness of the company's balloon-expandable renal stent for the treatment of renal artery stenosis. The data, presented by Robert Bersin, M.D., at ISET 2011, reveal a nine-month primary patency rate of 89.5 percent and a 97 percent rate of successful delivery and deployment of the stent.
"The data for the REFORM clinical trial reflect the clinical performance and patency of this dedicated renal stent platform," said Dr. Bersin, the study's principal investigator and medical director of endovascular services at Seattle Cardiology and Swedish Medical Center. "These initial data indicate the balloon-expandable stent may offer a new treatment option for patients suffering from renal artery blockages."
One hundred patients were enrolled at seven investigative sites throughout the United States. Initial data were compiled at nine months post-procedure and benchmarked against well-established performance data.
"We are pleased with the clinical data associated with this balloon-expandable renal stent," said Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention division. "Cook will continue to pursue clinical improvements in peripheral stenting as part of our long-term mission to expand peripheral intervention to new classes of 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 accumulate within these arteries. Older treatment options such as balloon angioplasty do not always result in permanent reopening of the narrowed blood vessel, prompting investigators to explore alternatives such as stenting to improve long-term patient outcomes.