A drug-coated stent from Cook Medical met safety and effectiveness goals in the treatment of blocked femoral arteries, according to a staff report by U.S. regulators weighing whether to clear the device for sale. Clinical trials showed closely held Cook’s stent, the Zilver PTX, worked as well as or better than angioplasty and non-medicated stents in unclogging vessels, Food and Drug Administration staff said in a preliminary review released today on the agency’s website. Outside advisers to the FDA will meet Oct. 13 to evaluate the findings.
