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PIPELINE INNOVATIONS OVER THE LAST 10 YEARS
PITA
Study Finds intracranial aneurysm treatment with PED can be achieved with a safety profile analogous to that reported for stent-supported coil embolization.4
The American Journal of Neuroradiology releases a retrospective study on the device for cerebral aneurysm treatment.
technical success rate for PED placement4
of patients demonstrated a complete aneurysm occlusion at 180 days follow up4
cases of high-grade or symptomatic stenosis during a 180-day follow-up after implantation4
The study finds
complete aneurysm occlusion rate at 1 year follow up5*
INTREPED
finds aneurysm treatment with PED is associated with the lowest complication rates when used to treat small internal carotid artery (ICA) aneurysms.8
The study finds...
neurological morbidity and mortality rate8
spontaneous rupture rate8
PED declared safe and effective for large and giant aneurysms in certain ICA locations in PUFs 3 year follow-up9
Complete aneurysm occlusion at 3 year follow up9*
No new morbidity events from 6 months to 3 years9
major ipsilateral stroke or neurological death from 6 months to 5 years5
complete anuerysm occlusion rate at 5 year follow-up5*
ecurrence of aneurysms after complete occlusion5*
The only multi-center Flow Diverter study with 5-year occlusion data5
The PUFS 5 year Publication wins congress of Neurological Sciences Paper of the Year Award10
technical success rate for Pipeline™ placement12
complete aneurysm occlusion rate at 1-year post-procedure12
aneurysm recurrences at 1-year post-procedure12
Select and review the existing clinical data on safety and efficacy
Most cited publication within the flow diversion literature20.
Prospective case series
Treatment of large, wide-neck, or otherwise untreatable aneurysms with functional reconstruction of the parent artery may be achieved with relative safety using dedicated flow-modifying devices with or without adjunctive use of intrasaccular coil packing14.
Treatment of large, wide-neck, or otherwise untreatable aneurysms with functional reconstruction of the parent artery may be achieved with relative safety using dedicated flow-modifying devices with or without adjunctive use of intrasaccular coil packing15.
PITA Study Finds intracranial aneurysm treatment with PED can be achieved with a safety profile analogous to that reported for stent-supported coil embolization4
Prospective case registry
The clinical results from using the Pipeline™ embolization device for the treatment of nonruptured internal carotid artery aneurysms appeared encouraging.16
Prospective study
The clinical results from using the Pipeline™ embolization device for the treatment of nonruptured internal carotid artery aneurysms appeared encouraging.17
Retrospective study
Use of the PED is safe, e!cacious, and durable in cerebral aneurysm treatment, with low morbidity-mortality and high occlusion rates as confirmed with mid- to long-term control angiography.18
Prospective IDE study
PED offers a reasonably safe and elective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.3
Retrospective post-market
Aneurysm treatment with the Pipeline™ embolization device is associated with the lowest complication rates when used to treat small ICA aneurysms. Procedure-related morbidity and mortality are higher in the treatment of posterior circulation and giant aneurysms.8
Prospective IDE study
PED Declared Safe and Effective for Large and Giant Aneurysms in certain ICA locations in PUFs 3 year follow-up9
Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality.19
demonstrates that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.5
Prospective study
Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without signi!cant parent vessel stenosis and low rates of permanent neurologic complications.12
Together with our physicians partners, we are always advancing the innovation and
horizon of flow diversion therapy to improve outcomes for Patients worldwide.
“Once in a while an innovation comes along that completely transforms a therapy. This doesn’t happen often but when it does physicians will tell you.”
Brett Wall, Senior Vice President
“The studies that were done with Pipeline™, and flow diversion in general, have contributed hugely to expand indications and reaffirm this technology as a true and breakthrough for aneurysm treatment.”
Vitor Mendes Pereira, Associate Professor of Radiology and Surgery
"The biggest impact of flow diversion on patient care has been our ability to now treat certain aneurysms that were particularly difficult to treat in the past in a single session. This has increased our success rate tremendously."
Dr. Tibor Beckse MD, Neurologist
Kerri
After recovering from a brain surgery, Kerri was diagnosed with a brain aneurysm. Watch as she discusses her experience with flow diversion treatment.
Rene
Rene is an energetic, passionate 7th grade teacher—and he was diagnosed with an unruptured brain aneurysm. Watch his story through diagnosis and treatment.
Tonya
After experiencing a series of debilitating headaches, Tonya was diagnosed with a brain aneurysm. Watch her story as she discusses treatment and recovery.
Treatment with the Pipeline™ Flex Embolization device is only available by prescription. This treatment is not for everyone. Please talk to your doctor to see if it's right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, individual results may vary.
Based on angiographic imaging at each follow-up.
PMA-P100018
SA-00008-XX Rev. H
Becske T, et al. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013;267(3):858-868. doi:10.1148/radiol.13120099
Nelson, P.K., et al., The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial. AJNR Am J Neuroradiology, 2010: p. ajnr.A2421
Becske T. et al., Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial., (JNS) Neurosurgery.
PMA- P100018-S011
TR-NV10931/TR-NV11121 Rev. D
Kallmes DF, et al. International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol 2015;36:108–115.
Becske, Tibor, et al. "Pipeline for uncoilable or failed aneurysms: 3-year follow-up results". Journal of Neurosurgery JNS 127.1 (2017): 81-88. < https://doi.org/10.3171/2015.6.JNS15311>
PMA-P100018-S015
Hanel RA, et al Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results Journal of Neuro-Interventional Surgery 2020;12:62-66.
Lylyk P1, et al. Curative Endovascular Reconstruction of Cerebral Aneurysms with the Pipeline Embolization Device; The Buenos Aires Experience. Neurosurgery. 2009 Apr;64(4):632-42.
Szikora, I., et al. Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the Budapest experience with the pipeline embolization device. AJNR. American journal of neuroradiology, 31(6), 1139–1147. https://doi.org/10.3174/ajnr.A2023.
W. McAuliffe, et al. Immediate and Midterm Results Following Treatment of Unruptured Intracranial Aneurysms with the Pipeline Embolization Device AJNR Am J Neuroradiology, 2012 doi: 10.3174/ajnr.A2727.
Yu, et al. Intra-cranial aneurysms: Midterm outcome of Pipeline Embolization Device – A Prospective Study in 143 Patients with 178 Aneurysms. Radiology 2012.
Saatci, Cekirge, et al., Pipeline Flow-Divertor Embolization Device: A Single-Center Experience with Long-Term Follow-Up Results. Published July 19, 2012 as 10.3174/anjr.A3246
Kallmes DF, et al. Aneurysm Study of Pipeline in an Observational Registry (ASPIRe). Interv Neurol. 2016;5(1-2):89-99. doi:10.1159/000446503.
Elarjani, Turki et al. “Bibliometric Analysis of the Top 100 Most-Cited Articles on Intracranial Flow Diversion.” World neurosurgery vol. 146 (2021): e618-e630. doi:10.1016/j.wneu.2020.10.150
