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Overview of Newer Stent Devices for Aneurysm Treatment PDF
Preview Overview of Newer Stent Devices for Aneurysm Treatment
Overview of Newer Stent Devices for Aneurysm Treatment Randall C. Edgell, M.D. Associate Professor Vascular and Interventional Neurology Saint Louis University Disclosure • Outcome adjudication for THERAPY, Penumbra FDA Pathways • Premarket Notification (510[K]): may allow device to go to market if “substantially equivalent” to previously marketed devices • Pre-market Approval (PMA): Efficacy trial required – Investigational Device Exemption (IDE): allows use in clinical trials • Humanitarian Device Exemption (HDE): Only for rare diseases (<4,000 cases per year). Only requires demonstration of safety. Local IRB approval and monitoring required. WARNING • Most devises presented are investigational. • Seeking HDE or PMA approval. • Some slides/images graciously provided by industry Flow Diverting Stents PipelineTM Embolization Device(Covidien) • 30-35% surface coverage at nominal diameter • 48-strand braided mesh • 75% cobalt chromium/25% platinum tungsten • Scaffolding for endothelial repavement • Branch vessels preserved PipelineTM Embolization Device(Covidien) PipelineTM Flex Embolization Device(Covidien) Improved delivery systemt New distal wire Resheathable No protective coil SurpassTM Flow Diverter (Stryker) • High pore density (72- wire & 96-wire braids) • Long lengths (15mm to 50mm) • 3mm, 4mm, 5mm diameters SurpassTM Flow Diverter (Stryker) Pusher Delivery Catheter Surpass Flow Diverter