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September 23, 2010
Cook Medical Applies for FDA Approval of Its Balloon-Expandable Renal Artery Stent
September 24, 2010—Cook Medical (Bloomington, IN) announced that the company has submitted its premarket approval application to the US Food and Drug Administration for its new balloon-expandable stent for renal artery disease. The device is intended to treat patients with renal artery stenosis. Features of the device include a low-profile design that does not shorten on expansion.
The company stated that the premarket approval submission includes data from the REFORM clinical trial, which enrolled 100 patients at seven sites throughout the United States.
“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,” commented Robert Bersin, MD, the REFORM trial's principal investigator. “Balloon angioplasty has historically been the preferred approach to treating this condition but can require reintervention of the narrowed blood vessel. Stenting typically increases patency compared to balloon angioplasty.”
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