Medtronic has obtained FDA approval for its Pipeline Flex embolization device with Shield technology. The original Flex Pipeline was the first commercially available flow diverter for cerebral aneurysms. Shield Technology, a new surface treatment that now includes the device, helps reduce the tendency of the device itself to produce clots.
A few days ago, the Langone Health Center at New York University in New York City was the first hospital in the United States to use the flexible pipe embolization device with Shield technology. “The Flex-Shield Pipeline we used today at NYU Langone to treat a giant left internal carotid aneurysm represents a key milestone in the evolution of flow diversion therapy, setting a new vanguard for safe and effective management of complex brain aneurysms, ”he said. Peter Kim Nelson, MD, head of Interventional Neuroradiology and professor of Radiology and Neurosurgery at NYU Langone Health, in a Medtronic press release. “Our team has long been waiting for the availability of this device for patients in the United States. Implant surface modification has demonstrated reduced material thrombogenicity, discernibly aiding delivery through a tortuous vascular anatomy with improved delivery and coating forces compared to previous generation flow diverters. ”
Some details of a study evaluating the pipeline with Shield Tecnhology, according to Medtronic:
“… the results of the SHIELD study (one-year periprocedural results on safety and efficacy with the pipe embolization device with Shield technology for intracranial aneurysms: a prospective multicenter post-marketing study) show that embolization of third-generation Pipeline Flex The device with Shield technology continues the strong record of safety and efficacy of flow diversion therapy with the Medtronic product family. The results show 77.2% complete aneurysm occlusion at 12 months, a primary endpoint of 3.2%, and 93.1% complete wall apposition after the procedure.
Underlying device information page: Pipeline Flex
Study related to Journal of NeuroInterventional Surgery: Periprocedural to safety and efficacy results for one year with the pipe embolization device with Shield technology for intracranial aneurysms: a prospective post-marketing and multi-center study
Flashbacks: Covidien Flex Pipeline Cerebral Blood Flow Deviation Device to Treat Brain Aneurysms; Medtronic’s flexible pipe embolization device lands FDA approval; Flexible pipe embolization device approved for small and medium brain aneurysms