Cook Medical Files Pre-Market Approval Application for FDA Approval of A Balloon Expandable Stent for Renal Artery Disease
Published: Sep 24, 2010
BLOOMINGTON, Ind.--(BUSINESS WIRE)--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.