April 21, 2021 – Medtronic plc (Dublin, Ireland) 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.
Celebrating its 10-year anniversary in the U.S. in 2021, Pipeline Flex Embolization Device diverts blood flow away from a brain aneurysm. The first commercially available flow diverter in the market, the device features a braided cylindrical mesh tube that is implanted across the base, or neck, of the aneurysm.
The device interrupts blood flow into the aneurysm, reconstructing the diseased section of the parent vessel. Pre-clinical testing shows how Shield Technology improves Pipeline Flex by reducing the thrombogenicity of the device material, the company says.