India's drug regulator issued a warning against Abbott India's bioresorbable stents used in blood vessels that measure up to 2.5mm in diameter and has also called for Phase IV trials of the company's vascular stent. A spokesperson for the company said Abbott is working with India's Central Drugs Standard Control Organization, has submitted updated instructions for use that would change the vessel diameter for the device and has submitted a plan for clinically monitoring patients with the Absorb dissolving stent.
Warning on Abbott's bioresorbable stents issued by Indian drug regulator
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