Cook Medical filed a Pre-Market Approval (PMA) application with the FDA for its new balloon expandable stent for renal artery stenosis (RAS).
RAS is the narrowing of the arteries that supply blood to the kidneys, and a leading cause of high blood pressure. RAS is commonly treated with oral medications, angioplasty and stents. Cook’s new stent is intended to improve blood flow to the kidneys and does not shorten upon expansion, the Bloomington, Ind.-based medical device manufacturer said.
Cook’s PMA submission includes data from the REFORM clinical trial, which enrolled 100 patients at seven investigative sites throughout the U.S.