Medtronic plc 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. 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. Published on June 1, 2020, in the Journal of NeuroInterventional Surgery (JNIS), results from the SHIELD Study (Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study) demonstrate that the third-generation Pipeline Flex Embolization Device with Shield Technology continues the strong record of safety and efficacy of flow diversion therapy with the Medtronic family of products. Results show 77.2% complete aneurysm occlusion at 12 months, a 3.2% primary safety endpoint, and 93.1% complete wall apposition post-procedure. An estimated 500,000 people throughout the world die each year due to ruptured brain aneurysms, with half the victims younger than 50 years of age. As the most studied flow diverter worldwide, Pipeline Embolization Device has been used to treat patients in the United States since 2011 and is now available with Shield Technology.