>100K

Patients treated with Shield Technology™2

>58K

Studied in over 58K patients worldwide3

>1K

Studied in more than 1,000 publications worldwide3

Pioneers of flow diversion

Medtronic has been a pioneer in flow diversion for over 15 years with more than 100K patients treated with Shield Technology™. We have set the benchmark in flow diversion excellence worldwide with high rates of complete occlusion, optimal wall apposition and backed with a legacy of innovation as the world's first surface modified flow diverter with 10-year follow up data4. See how the Pipeline™ Embolization Device Family has evolved over the years from the perspective of a healthcare profession and a Medtronic engineer:

Healthcare professional

Hear from Prof. Hal Rice on his journey with the Pipeline™ Family through the generations.

Engineer

Discover more with Medtronic Engineering Director, Evan Epstein, as he talks through the evolution of the Pipeline™ Family from an engineer's lens.

History of Pipeline

2008

Pioneered the World's First Flow Diverter

2016

INSPIRE A

Worlds first post market surveillance registry for new technology

2017

PUFS 5yr follow up 

Long term efficacy & safety 95% occlusion, no major strokes5

INSPIRE A - Clinical Events Committee (CEC)

Ensuring robust & independent assessent


2020

Post Market registry

First society endorsed post market registry  INSPIRE A

The Worlds first Core Lab adjudicated PMCF

INSPIRE A, Ensuring robust & independent assessment

2023

First & only 10yr follow up study

100% Complete occlusion rate6

Braid deformation clinical reporitng standards

Drove the first society endorsed 
standardized methodology7


2025

Bold decision

A committment to Braid Deformation exploration and resolution.


Excellence driven by data

With more than 1,000 studies worldwide3, the Pipeline™ Embolization family is driving the forefront of clinical evidence. We have a wide range of clinical studies demonstrating consistently high complete occlusion and good safety profile featuring the Medtronic Pipeline™ Embolization Device Family. Explore the data below:

World Map

SCOPE AUS Study  |  Real world performance8

Study Design

Setting:
Multi-center, single-arm, retrospective study
Aneurysms treated
278
Patients
238
Aneurysms
Unruptured Intracranial Aneurysms



Overall Occlusion
At 18 months


Morbidity
Unruptured ICA aneurysms


Mortality
of unruptured ICA aneurysms

SHIELD Study  |  Real world performance9

Study Design

Setting:
Prospective, post market, multi-centre study
Hospitals
21
Patients
204
Aneurysms
Intracranial Aneurysms



Complete Occlusion
At 12 months


Morbidity
Combined


Mortality
Combined

PREMIER Study  |  Real world performance10

Study Design

Setting:
Prospective, single-arm trial
Patients
141
Aneurysms
Unruptured wide necked small and medium intracranial aneurysms



Complete Occlusion
At 3 years


Combined safety endpoint
At 3 years


Primary effectiveness endpoint
At 3 years

INSPIRE A Study  |  Real world performance11

Study Design

Setting:
Real-world, observational, prospective, multi-center registry
Hospitals
40
Patients
700
Aneurysms
Intracranial aneurysms



Overall Occlusion
(315/417)
Last follow-up, DSA only


Major Stroke
(13/530)


Mortality
(11/530)

Monteiro et al  |  Real world performance6

Study Design

Setting:
Retrospective review
Aneurysms treated
92
Patients
83
Aneurysms
Intracranial Aneurysms



Complete Occlusion
At 10 years
(15/15)


Retreatment
At 10 years
(1/15)


Treatment related complications
Nonfatal


References:

  1. Elarjani T, Almutairi OT, Bafaquh M, Alturki AY. Bibliometric Analysis of the Top 100 Most-Cited Articles on Intracranial Flow Diversion. World Neurosurg. 2021 Feb;146:e618-e630. doi: 10.1016/j.wneu.2020.10.150. Epub 2020 Nov 2. PMID: 33152498.
  2. Medtronic sales data on file; CL-020424
  3. Data on file; TR-NV11820 Rev W
  4. PMA #s P100018, P100018-S011, P100018-S026 and P100018-S034
  5. 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.
  6. Monteiro A, Lim J, Siddiqi M, Donnelly BM, Khawar W, Baig A, Turner RC, Bouslama M, Raygor KP, Lai PMR, Housley SB, Davies JM, Snyder KV, Siddiqui AH, Levy EI. The first decade of flow diversion for intracranial aneurysms with the Pipeline embolization device. Neurosurg Focus. 2023 May;54(5):E2. doi: 10.3171/2023.2.FOCUS22646. PMID: 37127038.7. Fiehler J, Ortega-Gutierrez S, Anagnostakou V, Cortese J, Cekirge HS, Fiorella D, Hanel R, Kulcsar Z, Lamin S, Liu J, Lylyk P, Marden FA, Pereira VM, Psychogios MN, Rice H, Rouchaud A, Saatci I, Siddiqui AH, Spelle L, Yang P, Grams A, Gounis MJ. Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN. J Neurointerv Surg. 2025 May 22;17(6):632-639. doi: 10.1136/jnis-2023-021404. PMID: 38830670; PMCID: PMC12171491.
  7. Fiehler J, Ortega-Gutierrez S, Anagnostakou V, Cortese J, Cekirge HS, Fiorella D, Hanel R, Kulcsar Z, Lamin S, Liu J, Lylyk P, Marden FA, Pereira VM, Psychogios MN, Rice H, Rouchaud A, Saatci I, Siddiqui AH, Spelle L, Yang P, Grams A, Gounis MJ. Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN. J Neurointerv Surg. 2025 May 22;17(6):632-639. doi: 10.1136/jnis-2023-021404. PMID: 38830670; PMCID: PMC12171491.
  8. Chia GS, de Villiers L, Carraro do Nascimento V, Rapier CL, Owusu MA, Lau FS, McQuinn A, Williams C, Whitley J, Cheung A, Manning NW, Rice H. Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort (SCOPE-AUS). Stroke Vasc Interv Neurol. 2022 Jun 17;2(5):e000292. doi: 10.1161/SVIN.121.000292. PMID: 41584013; PMCID: PMC12778814.
  9. Rice H, Martínez Galdámez M, Holtmannspötter M, Spelle L, Lagios K, Ruggiero M, Vega P, Sonwalkar H, Chapot R, Lamin S. Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study. J Neurointerv Surg. 2020 Nov;12(11):1107-1112. doi: 10.1136/neurintsurg-2020-015943. Epub 2020 Jun 1. PMID: 32482834; PMCID: PMC7569365.
  10. Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, István IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15. PMID: 35292570; PMCID: PMC9985759.
  11. D01295063 Rev C