Interventional technology firm Cook Medical has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for a balloon-expandable stent for renal artery disease.
Targeted at patients suffering from renal artery stenosis, the stent features a low-profile design and does not shorten upon expansion, according to the Bloomington, IN-based vendor. The PMA submission includes data from the REFORM clinical trial, which studied 100 patients at seven investigative sites in the U.S., Cook said.
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