M Martínez-Galdámez1, A Gil2, J L Caniego3, E Gonzalez2, E Bárcena3, S Perez1, P Garcia-Bermejo1, S Ortega-Gutierrez4. 1. Interventional Neuroradiology/Endovascular Neurosurgery Division, Department of Radiology, Hospital Clínico Universitario, Valladolid, Spain. 2. Interventional Neuroradiology, Radiology Department, Hospital de Cruces, Bilbao, Spain. 3. Interventional Neuroradiology, Radiology Department, Hospital La Princesa, Madrid, Spain. 4. Interventional Neuroradiology/Endovascular Neurosurgery Division, Department of Neurology and Anesthesia, University of Iowa, Iowa City, Iowa, USA.
Abstract
BACKGROUND: Clinical experience with the Pipeline Embolization Device (PED) has been widely described in the literature since it obtained its European CE and FDA approvals in 2008 and 2011, respectively. The new generation of PED, the Pipeline Flex Embolization Device, received the CE mark of approval in March 2014. While the implant composition has not changed, its new delivery system has some differences. One of the main changes from the previous generation is a new delivery system that makes the device resheathable until deployed over 90% of its length. We present our preliminary experience using this device. METHODS: Between May and June 2014, six patients with six aneurysms were treated with the Pipeline Flex device. RESULTS: All devices were placed properly, without technical difficulties. We successfully resheathed and repositioned the device in two cases. Minor and major intraprocedural or periprocedural events were noted. CONCLUSIONS: The Pipeline Flex device allows more precise and controlled deployment than the current PED device. Although this preliminary experience seems positive, multicenter larger series will be needed to confirm the safety and durability of this new device. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
BACKGROUND: Clinical experience with the Pipeline Embolization Device (PED) has been widely described in the literature since it obtained its European CE and FDA approvals in 2008 and 2011, respectively. The new generation of PED, the Pipeline Flex Embolization Device, received the CE mark of approval in March 2014. While the implant composition has not changed, its new delivery system has some differences. One of the main changes from the previous generation is a new delivery system that makes the device resheathable until deployed over 90% of its length. We present our preliminary experience using this device. METHODS: Between May and June 2014, six patients with six aneurysms were treated with the Pipeline Flex device. RESULTS: All devices were placed properly, without technical difficulties. We successfully resheathed and repositioned the device in two cases. Minor and major intraprocedural or periprocedural events were noted. CONCLUSIONS: The Pipeline Flex device allows more precise and controlled deployment than the current PED device. Although this preliminary experience seems positive, multicenter larger series will be needed to confirm the safety and durability of this new device. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Mario Martínez-Galdámez; Saleh M Lamin; Konstantinos G Lagios; Thomas Liebig; Elisa F Ciceri; Rene Chapot; Luc Stockx; Swarupsinh Chavda; Christoph Kabbasch; Giuseppe Farago; Hannes Nordmeyer; Thierry Boulanger; Mariangela Piano; Edoardo P Boccardi Journal: J Neurointerv Surg Date: 2017-02-20 Impact factor: 5.836
Authors: Hans Henkes; Pervinder Bhogal; Marta Aguilar Pérez; Tim Lenz-Habijan; Catrin Bannewitz; Marcus Peters; Christina Sengstock; Oliver Ganslandt; Pedro Lylyk; Hermann Monstadt Journal: Interv Neuroradiol Date: 2019-06-27 Impact factor: 1.610