The U.S. Food and Drug Administration (FDA) granted Medtronic’s Pipeline™ Flex Embolization Device with Shield Technology™ regulatory approval. The Shield Technology is designed to introduce the first surface-modified implant device that reduces the tendency of the surface material to create clots, thus advancing flow diversion therapy for brain aneurysms. The first procedure to take place in the US was performed at NYU Langone Health in New York City. Chief of Interventional Neuroradiology and Professor of Radiology and Neurosurgery at NYU Langone Health, Peter Kim Nelson, M.D., stated, “The Pipeline Flex-Shield that we used today at NYU Langone to treat a giant left internal carotid aneurysm, represents a pivotal milestone in the evolution of flow diversion therapy—establishing a new vanguard for safe and effective management of complex cerebral aneurysms. Our team has long-anticipated the availability of this device for patients in the United States. The surface modification of the implant has demonstrated reduced material thrombogenicity, discernably aiding delivery through tortuous vascular anatomy with improved delivery and resheathing forces compared to earlier generation flow diverters.”
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