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FDA Class I Recall for Medtronic's Flex Embolization Devices

FDA Class I Recall for Medtronic's Flex Embolization Devices
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Drug Administration , Pipeline Flex , Flex Embolization Device , Shield Technology , Medscape Medical , Medtronic Quality Assurance ,

Medtronic Receives U.S. FDA Approval for Pipeline™ Flex Embolization Device with Shield Technology™

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First Patient Receives New Shield Surface Modification, An Advance in Flow Diversion Therapy, at NYU Langone Health
DUBLIN, April 21, 2021 /PRNewswire/ Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for Pipeline™ Flex Embolization Device with Shield Technology™. Medtronic developed Shield Technology, a proprietary breakthrough in biomaterial science, to advance flow diversion therapy by introducing the first surface-modified implant device which demonstrates reduction in material thrombogenicity, a reduction in the tendency of the surface treatment material to create clots. NYU Langone Health in New York City performed the first patient procedure in the nation with the new device. ....

New York , United States , Davidt Young , Dan Volz , Prnewswire Medtronic , Peter Kim Nelson , Todd Crawford , Ryan Weispfenning , Exchange Commission , Langone Health , Drug Administration , Lisa Foundation , Flow Diversion Therapy , United States Food , Flex Embolization Device , Shield Technology , New York City , Pipeline Flex Embolization Device , Pipeline Flex , Pipeline Flex Shield , Interventional Neuroradiology , Neurointerventional Surgery , Pipeline Embolization Device , Neuroscience Portfolio , புதியது யார்க் , ஒன்றுபட்டது மாநிலங்களில் ,