Washington, DC (July 13, 2023) – The Society for Cardiovascular Angiography & Interventions (SCAI) President George D. Dangas, MD, PhD, MSCAI, released the following statement in response to the release of updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease by the U. S. Food & Drug Administration (FDA):
“SCAI applauds the FDA for its decision to reverse restrictions on using paclitaxel-coated devices to treat peripheral artery disease, based on continued efforts to collect and analyze data related to the mortality risk for these devices. SCAI, with a broad coalition of physician stakeholders, worked to provide the FDA with additional data used by the agency to update its previous guidance. We encourage SCAI members to continue to follow guidance from the FDA when evaluating appropriate treatment for patients.”
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