PIPELINE™ THE MOST STUDIED FLOW DIVERTER WORLDWIDE* Flow Diverters
Pipeline™ is the reference in flow diversion, grounded by more than 46,000 patients studied, over 400 publications and up to 10-year follow up data.* These devices changed the treatment of aneurysms. By diverting flow away from the aneurysm neck and reconstructing the parent artery, they allow the flow to restore its natural course.
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Overview
PIPELINE™ VANTAGE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY™
After more than 10 years of development in flow diversion therapies, the 4th generation Pipeline™ VANTAGE Embolization Device with Shield Technology™ continues the legacy by providing meaningful innovation with delivered enhancements in biomaterial science & technology.
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Pipeline™ Flex with Shield Technology™
This 3rd generation Pipeline™ flow diverter offers Shield Technology™.
Shield Technology™ builds on the clinically proven treatment of certain wide-necked intracranial aneurysms with the Pipeline Flex™ embolization device, by introducing an innovative implant surface modification, designed to advance flow diversion therapy.2,3
SHIELD TECHNOLOGY™
Shield Technology™ is designed to improve the hemocompatibility3,4 and deliverability4 of the Pipeline™ implant by integrating synthetic phosphorylcholine (PC) to the surface of the braid.
PRODUCT DETAILS
Human Blood Loop Model Results2
Pipeline™ Flex Shield Technology™ addresses one of the common barriers to the flow diversion therapy: material thrombogenicity. Through covalently bonding PC to the surface of the implant, the Shield Technology™ surface modification enhances Pipeline™ Flex to achieve a scientifically proven reduction in implant material thrombogenicity.3,4*
*Data derived from the referenced bench studies and may not be representative of clinical performance.
PIPELINEtm FLEX
embolization
DEVICE
A clinically proven, cobalt-chromium and platinum-tungsten flow diversion device that’s resheathable and redeployable.
PUFs Study
Results5*
95%
Occlusion at
5 year follow-up
0%
Recurrence at
5 years after
inital occlusion
* Results from PUFs trial derived from use of the Pipeline™ Embolization Device.
NOW SHIELDED
BY SCIENCE
SHIELD Study
Results6
REDUCES MATERIAL THROMBOGENICITY.
3.23%
Primary Safety Endpoint
PROMOTES ENDOTHELIALIZATION.
77.2%
Complete Aneurysm Occlusion at 12 Months
IMPROVES
PERFORMANCE.
93.1%
Complete Wall Apposition Post-Procedure
PFLEX
study results
Initial clinical data shows that Pipeline™ Flex with Shield Technology™ is safe and effective for the treatment of intracranial aneurysms.
PFLEX Study
Results7
0%
Target aneurysm recurrence7
0%
Target aneurysm recurrence7
0%
Major stroke in the territory supplied by the treated artery7
How to deliver flow diverters?
It is recommended to use a 0.027 microcatheter for the delivery of PipelineTM Flex with Shield TechnologyTM Flow Diverters.
LEARN MORE ABOUT PHENOM 027 MICROCATHETERSSPECIFICATIONS
INDICATIONS
The Pipeline™ Flex embolisation device with Shield Technology™ is intended for endovascular embolisation of cerebral aneurysms.
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*
At the time of publication in June 2023. See medtronic.com/vantagedata
1
Number of studies including Pipeline: 48 as of June 2019
2
Girdhar G, Andersen A, Pangerl E, Jahanbekam R, Ubl S, Nguyen K, Wainwright J, Wolf MF. Thrombogenicity assessment of Pipeline Flex, Pipeline Shield, and FRED flow diverters in an in vitro human blood physiological flow loop model. J Biomed Mater Res A. 2018 Dec;106(12):3195-3202. doi: 10.1002/jbm.a.36514. Epub 2018 Sep 22. PMID: 30242950; PMCID: PMC6282594.
3
Girdhar G, Li J, Kostousov L, Wainwright J, Chandler WL. In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices. J Thromb Thrombolysis. 2015 Nov;40(4):437-43. doi: 10.1007/s11239-015-1228-0. PMID: 25975924.
4
Medtronic Internal Study, D00422708 Rev. A, Competitive Test Report - Material Thrombogenicity Evaluation of Flow Diversion Devices.
5
Mario Martínez-Galdámez et al. Treatment of intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™: angiographic and safety outcomes at 1-year follow-up. JNIS 2018
6
Becske T, Brinjikji W, Potts MB, Kallmes DF, Shapiro M, Moran CJ, Levy EI, McDougall CG, Szikora I, Lanzino G, Woo HH, Lopes DK, Siddiqui AH, Albuquerque FC, Fiorella DJ, Saatci I, Cekirge SH, Berez AL, Cher DJ, Berentei Z, Marosfoi M, Nelson PK. 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. Neurosurgery. 2017 Jan 1;80(1):40-48. doi: 10.1093/ neuros/nyw014. PMID: 28362885.
7
Rice H, Martínez Galdámez M, Holtmannspötter M, et al. J NeuroIntervent Surg Epub ahead of print: June 1, 2020. doi:10.1136/neurintsurg-2020-015943
8
Mario Martínez-Galdámez et al. Treatment of intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™: angiographic and safety outcomes at 1-year follow-up. JNIS 2018
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu