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Background: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2)., Methods: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used., Results: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms)., Conclusions: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%)., Clinical Trial Registration: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322., Competing Interests: Competing interests: LP reports support for the present manuscript from Microvention; consulting fees from Balt, Microvention, Perflow, Phenox, Vesalio; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Balt, Microvention, Perflow, Phenox, Vesalio; support for attending meetings and/or travel from Balt, Microvention, Phenox. IS reports grants or contracts from National Brain Research Fund (Hungary); consulting fees from Stryker, Microvention, Medtronic, Cerenovus; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medtronic, Stryker, Cerenovus; support for attending meetings and/or travel from Gabriel Vegh Neurointerventional Fondation (Hungary); leadership in European Board of NeuroIntervention (EBNI), Hungarian Sociaty of Neuroradiology, Hungarian Society of Neurosurgery, Hungarian Stroke Society. XB reports consulting fees from Sequent; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Sequent. MH reports consulting fees from Balt, Stryker, Medtronic, Microvention, Phenox; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Cerenovus, Phenox, Stryker, Microvention, Cerus Medical. LSp reports grants or contracts from Philips (institutional); consulting fees from Balt, Medtronic, Phenox, Microvention, Stryker; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Balt, Medtronic, Microvention, Stryker; support for attending meetings and/or travel from Balt, Medtronic, Microvention, Stryker. JK reports consulting fees from Microvention, Phenox. DH reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; support for attending meetings and/or travel from Microvention. VC reports grants or contracts from Medtronic, Cerenovus, Stryker, Balt, Microvention; consulting fees from Medtronic, Stryker, Microvention; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medtronic, Stryker, Microvention; leadership in Sim & Cure. JF reports grants or contracts from Microvention (institutional); consulting fees from Microvention, Sequent; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; leadership role in JNIS (Associate Editor). A-CJ reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; leadership in European Society for Minimally Invasive Neurological Therapy (ESMINT). TL reports consulting fees from Microvention, Cerus Endovascular; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Stryker, Cerus Endovascular; support for attending meetings and/or travel from Stryker, Cerus Endovascular. LSt reports no disclosures. WW reports consulting fees from Microvention. JBe reports consulting fees from Siemens (institutional). JM reports consulting fees from Microvention: other financial interests from Balt. AM reports CEC services to Sequent Medical and Microvention (institutional); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; support for attending meetings and/or travel from Microvention. JBy reports core laboratory services to Sequent Medical and Microvention (institutional); consulting fees from Oxford Endovascular Ltd and Microvention; core laboratory activities for Sequent and Microvention; leadership (Board Member) of Oxford Endovascular Ltd; stock in Oxford Endovascular Ltd., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The use of flow diversion to treat intracranial aneurysms has increased in recent years., Objective: To assess the safety and angiographic efficacy of the p64 flow modulation device., Methods: Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography., Results: A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10)., Conclusions: Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity., Competing Interests: Competing interests: ABo serves as a consultant for Balt, phenox, and Stryker. MAP serves as proctor and consultant for phenox. HH is a co-founder and shareholder of phenox, femtos, and CONTARA; serves as proctor and consultant for phenox; and declares personal financial interest in Johnson & Johnson and Penumbra. PL, CB, GG, SS, AS, AP, CR, A-PN, XB, AC, CWa, MDO, SY, NPN, CWe have no personal, financial, or institutional interest to report. LSt declares personal financial interest for Medtronic and Terumo. FT serves as a consultant for Balt and Medtronic. CL declares proctoring and consultant services for phenox and also serves as consultant for Penumbra and receives travel and meeting expanses from Acandis and Penumbra. ABe serves as consultant for Microvention and as CEC chairman for phenox for the ARTESp trial. LP declares consulting services for Balt, Cerus Endovascular, Microvention, Perflow, phenox, and Vesalio. MM serves as a proctor for Penumbra and declares support for Procardia and Polimed. TG serves as a proctor for phenox. JK serves as a proctor and consultant for Microvention and phenox with payment to his institution. LSp is a consultant for Balt, Medtronic, Microvention, phenox, and Stryker and also declares support for Balt, Medtronic, Microvention, and Stryker outside of this work. FC serves as a consultant for Balt, Medtronic, and Stryker; receives payment for support of Penumbra; and participates as DSMB/advisory board of Microvention. PK serves as proctor and consultant for phenox and received travel and meeting expenses from phenox. SD declares no other competing interests besides that he was the President of the Central and Eastern European Committee of ESMINT until September 2020. TW serves as consultant for phenox. PS serves as consultant for Penumbra, phenox, and Stryker., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: The Woven EndoBridge (WEB) is an intrasaccular flowdisruptor that is increasingly used for the treatment of (wide-necked) aneurysms. We present our experience with the WEB for unruptured aneurysms., Materials and Methods: Between April 2014 and August 2019, 93 patients with 95 unruptured aneurysms were primarily treated with the WEB. There were 69 women and 24 men, mean age 61 years (median 58, range 37-80)., Results: Of 95 aneurysms, 86 had been discovered incidentally, 3 were symptomatic and 6 were additional to another ruptured aneurysm. Location was anterior communicating artery 33, middle cerebral artery 29, basilar tip 19, carotid tip 8, posterior communicating artery 4, posterior inferior cerebellar artery 1, superior cerebellar artery 1. Mean aneurysm size was 6 mm (median 6, range 3-13 mm).In one aneurysm additional coils were used and in another, a stent was placed. There was one procedural rupture without clinical sequelae. There were two thrombo-embolic complications leading to permanent deficit in one patient (mRS 2). Morbidity rate was 1.0% (1 of 93, 95%CI 0.01-6.5%) and mortality was 0% (0 of 93, 95%CI 0.0-4.8%). Angiographic follow-up at six months was available in 85 patients with 87 aneurysms (91%). Of 87 aneurysms, 68 (78%) were completely occluded, 14 (16%) had a neck remnant and 5 were incompletely occluded. Four aneurysms were retreated. Retreatment rate was 4.5% (4 of 87, 95%CI 1.7-13.6%)., Conclusion: WEB treatment of unruptured aneurysms is safe and effective. Additional devices are needed only rarely and retreatment at follow-up is infrequent.

Background: The novel low-profile p48 flow diverter has been designed to treat aneurysms on small vessels of 1.75-3mm. We report our first clinical experiences., Methods: Between March 2018-January 2020, 22 patients with 25 aneurysms were treated with the p48 in 3 centers. One patient had 3 aneurysms covered by one p48 and one patient had 2 aneurysms. There were 5 men, 17 women, with a mean age of 55 years (median 59, range 29-73 years)., Results: In 25 aneurysms, 24 p48 flow diverters were placed. In 1 patient additional coils were placed in the aneurysm. Procedural vessel rupture by the micro guidewire occurred in 2 patients and vessel rupture during p48 balloon dilatation occurred in 1 patient. Overall, the permanent morbidity rate was 13.6% (3 of 22, 95%CI 3.9-34.2%) and mortality was 4.5% (1 of 22, 95%CI <0.01-23.5%). Most complications were procedure-related and not device-specific. Of 22 patients with 25 aneurysms treated with p48, 18 patients with 20 aneurysms had angiographic follow-up after 5-18 months. Of 19 aneurysms, 10 were occluded and 7 showed a remnant. Two aneurysms were open after 6 months. Three aneurysms were still not occluded after 12, 14, and 18 months and these 3 were retreated. Retreatment rate was 16% (3 of 19) and the adequate occlusion rate was 90% (17 of 19)., Conclusions: Treatment of aneurysms in small-caliber vessels with the p48 is feasible and effective but is not without complications. More data is needed to establish indications, safety, and efficacy more accurately.

Background: WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2)., Methods: Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant., Results: The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%., Conclusions: This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322., Competing Interests: Competing interests: LP consults for Balt, MicroVention, Neuravi, and Penumbra. ISI consults for Codman, Medtronic, Sequent, and Stryker. XB consults for MicroVention and Stryker. LS consults for Stryker, MicroVention, Medtronic, and Balt. JF has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, and the EU. VC consults for MicroVention and Balt, and receives educational grants from Medtronic and Stryker. JK consults for MicroVention/Sequent. WW consults for MicroVention, Phenox, and Medtronic. TL consults for Medtronic, Mentice, Microvention, and Route 92. JM consults for Medtronic, MicroVention, Stryker, and Balt. AM consults for MicroVention/Sequent and Cerus Endovascular. JB consults for, and is shareholder of, Oxford Endovascular Ltd; his institution received funding from MicroVention., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Purpose: Flow diverters are increasingly used to treat intracranial aneurysms. We report the safety and efficacy of the p64 flow diverter, a resheathable and detachable device for intracranial aneurysms., Materials and Methods: We retrospectively reviewed 108 patients with 109 aneurysms treated with the p64 between March 2014 and July 2019. There were 87 women and 21 men, mean age 57 years. Of 109 aneurysms, 74 were discovered incidentally, 12 were symptomatic, 18 were previously treated, and five were ruptured dissection aneurysms. A total of 10 aneurysms were located in the posterior circulation. The mean aneurysm or remnant size was 8.1 mm., Results: Hemorrhage by perforation with the distal guidewire occurred in two patients with permanent neurological deficits in one. In one patient, acute in-stent occlusion caused infarction with a permanent deficit. Permanent morbidity was 1.9% (2 of 108, 95%CI 0.1-6.9%); there was no mortality. During follow-up, three in-stent occlusions occurred, all asymptomatic. There were no delayed hemorrhagic complications. At six months, 77 of 96 aneurysms (80.2%) were completely occluded, and at last follow-up, this increased to 93 of 96 aneurysms (96.9%). In-stent stenosis at any degree occurred in 11 patients, progressing to asymptomatic complete occlusion in one. In the other patients, stenosis resolved or improved at further follow-up., Conclusion: The p64 offers an effective and safe treatment option. Aneurysm occlusion rate was 97% at last follow-up, mostly achieved with a single device. There were no delayed hemorrhagic complications. Delayed in-stent stenosis infrequently progresses to occlusion but remains a matter of concern.

Background: Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2)., Objective: To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials., Methods: In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant., Results: The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%., Conclusion: This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%)., (© Congress of Neurological Surgeons 2020.)

Background: The supraorbital keyhole craniotomy is a well-established minimally invasive approach for the treatment of intracranial aneurysms. However, the surgical range of exposure using this technique for treatment of intracranial aneurysms has not been studied., Methods: We retrospectively reviewed the data of all clipped aneurysm cases using the supraorbital approach (SO) between 2006 and 2016 in our center. Most importantly, we determined the location of the treated aneurysms in the axial 2-dimensional plane, with the anterior clinoid process (ACP) as the point of reference: the ACP to aneurysm distance. Finally, we extracted data on patient age, aneurysm size, size of the craniotomy, length of hospital stay, and surgery-related complications., Results: We included 142 patients for this series. A total of 170 aneurysms were clipped by means of the SO, and in 18 cases multiple aneurysms were treated during the same surgery. The mean aneurysm size was 7 mm (3.5-22 mm) and the mean craniotomy size was 28 mm (19-41 mm). The aneurysm location ranged from 14.4 mm medially to 35 mm laterally, measured with the ipsilateral ACP as the zero reference., Conclusions: Although the SO is conventionally used in the treatment of anterior circulation aneurysms, we were able to treat aneurysms over a range of 50 mm over the skull base. With its low complication risk, relatively short hospital stay, and excellent cosmetic results, SO remains a valuable treatment option for both young and aged patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs., Materials and Methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year., Results: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment., Conclusions: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs., Trial Registration Number: NCT02390037., Competing Interests: Competing interests: MM-G serves as a proctor and consultant for Medtronic. SML proctors and consults for Medtronic. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy., Purpose: To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2., Methods: WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant., Results: The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%., Conclusions: This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment., Clinical Trial Registration: French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322)., Competing Interests: Competing interests: LP: consultant for Balt, Microvention, Neuravi, and Penumbra. JM: consultant for Medtronic, Microvention, Stryker, and Balt. XB: consultant for Microvention and Stryker. ISI: consultant for Codman, Medtronic, Sequent, and Stryker. VC: consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker. JF: has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, EU. JK: consultant for Microvention/Sequent. WW: consultant for Microvention, Phenox, and Medtronic. TL: consultant for Medtronic, Mentice, Microvention, and Route92. AM: consultant for Microvention/Sequent and Cerus Endovascular. JB: consultant and shareholder for Oxford Endovascular Ltd; his institution received funding from MicroVention. LS: consultant for Stryker, MicroVention, Medtronic, Balt. J-YG, HD, and SV have no disclosures., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background and Purpose: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer., Materials and Methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes., Results: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period., Conclusions: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods., Clinical Trial Registration: NCT02390037., Competing Interests: Competing interests: MM-G serves as a proctor and consultant for Medtronic. SML receives honoraria from Medtronic in relation to proctoring, speaking, and consulting. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background and Purpose: Flow disruption with the Woven EndoBridge (WEB) device is an innovative technique for the endovascular treatment of wide-neck bifurcation aneurysms. The initial version of the device (WEB Double-Layer) was evaluated in the WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST) study, whereas the French Observatory study evaluated both WEB Double-Layer and Single-Layer versions of the device. WEBCAST 2 was designed to evaluate the WEB Single-Layer with Enhanced Visualization., Materials and Methods: Patients with wide-neck bifurcation aneurysms for which WEB treatment was possible were included. Clinical data including adverse events and clinical status at 1 month and 1 year were collected and analyzed. A core laboratory evaluated anatomic results at 1 year following the procedure., Results: Ten European neurointerventional centers included 55 patients (38 women; 27-77 years of age; mean, 54.4 ± 10.0 years) with 55 aneurysms. Aneurysm locations were the middle cerebral artery in 25 aneurysms (45.5%), the anterior communicating artery in 16 (29.1%), the basilar artery in 9 (16.4%), and the internal carotid artery terminus in 5 (9.1%). Procedural morbidity and mortality at 1 month were, respectively, 1.8% (1/55 patients) and 0.0% (0/55 patients). Morbidity and mortality at 1 year were, respectively, 3.9% (2/51 patients) and 2.0% (1/51 patients). At 1 year, complete occlusion was observed in 27/50 aneurysms (54.0%); neck remnant, in 13/50 (26.0%); and aneurysm remnant, in 10/50 (20.0%) (adequate occlusion in 40/50, 80.0%)., Conclusions: WEBCAST 2 confirms the high safety and efficacy of WEB aneurysm treatment demonstrated in the WEBCAST and French Observatory studies., (© 2017 by American Journal of Neuroradiology.)