Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its new balloon expandable stent for renal artery disease. Intended for patients suffering from renal artery stenosis, a narrowing of the arteries that supply blood to the kidneys, the new device features a low profile design and does not shorten upon expansion. Cook's PMA submission includes data from the REFORM clinical trial, which enrolled 100 patients at seven investigative sites throughout the U.S.
“Filing for pre-market approval with the FDA is a significant step forward for us in bringing our new renal stent to market in the U.S.”
"Renal artery disease decreases the ability of the kidneys to filter and remove waste and fluids from the body, leading to possible renal insufficiency and kidney failure," said Dr. Robert Bersin, the trial's principal investigator and medical director of endovascular services at Seattle Cardiology and Swedish Medical Center. "Balloon angioplasty has historically been the preferred approach to treating this condition, but can require re-intervention of the narrowed blood vessel. Stenting typically increases patency compared to balloon angioplasty."
"Filing for pre-market approval with the FDA is a significant step forward for us in bringing our new renal stent to market in the U.S.," said Rob Lyles, vice president and global business unit leader of Cook Medical's Peripheral Intervention division. "The ongoing clinical trial has afforded us an opportunity to evaluate the impact of the stent on renal artery revascularization and related clinical outcomes, and we are confident this treatment method will diversify the interventional landscape."