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Study: No major difference in mortality between patients treated with drug-coated and non-drug-coated devices Peripheral artery disease (PAD), or blockages in the arteries outside of the heart, affects more than 200 million people worldwide and 12.5 million people in the United States. Patients with this circulatory disorder may develop severe leg pain or unhealing wounds that require a minimally invasive revascularization procedure to open the blood vessels to improve blood flow. For nearly a decade, proceduralists and surgeons have depended on devices coated with a drug called paclitaxel which reduces the need for another procedure by up to 50 percent during procedures to open the arteries of the leg. However, in the wake of a 2018 study that found a potential link between these drug-coated peripheral devices and death after two years post procedure, the FDA restricted the use of these devices for the treatment of PAD out of an abundance of caution.

United statesRobert yehEric secemskyEmily hendersonCenters for medicare medicaid servicesSusanf smith centerAmerican college of cardiology scientific sessionsHarvard medical schoolOutcomes researchBeth israel deaconess medical centerSafety assessmentMedicaid servicesAmerican collegeScientific sessions mayVascular interventionAssistant professor