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Cook Medical Files Pre-Market Approval Application for FDA Approval of A Balloon Expandable Stent for Renal Artery Disease


9/24/2010 10:15:15 AM

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.

Read at BioSpace.com


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