Medtronic has won FDA approval for its Pipeline Flex Embolization Device with Shield Technology. The original Pipeline Flex was the first commercially available flow diverter for brain aneurysms. Shield Technology, a novel surface treatment that now encompasses the device, helps to reduce the tendency of the device itself to produce clots.
A few days ago New York University’s Langone Health center in New York City was the first hospital in the U.S. to employ the Pipeline Flex Embolization Device with Shield Technology. “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,” said Peter Kim Nelson, M.D., chief of Interventional Neuroradiology and professor of Radiology and Neurosurgery at NYU Langone Health, in a Medtronic press release. “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, discernibly aiding delivery through tortuous vascular anatomy with improved delivery and resheathing forces compared to earlier generation flow diverters.”
Some details from a study evaluating the Pipeline with Shield Tecnhology, according to Medtronic:
“…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.
Underlying device info page: Pipeline Flex
Related study in Journal of NeuroInterventional Surgery: 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
Flashbacks: Covidien’s Pipeline Flex Brain Blood Flow Diversion Device for Treating Brain Aneurysms; Medtronic’s Pipeline Flex Embolization Device Lands FDA Approval; Pipeline Flex Embolization Device Approved for Small and Medium Brain Aneurysms