>100K

Shield™ devices implanted worldwide2

>58K

Patients studied for flow diversion worldwide3

>1K

Studies published in journals worldwide3

Pioneers of flow diversion

Medtronic have been the pioneers for over 15 years & more than 100K Shield™ devices have been implanted.2 We are setting the benchmark for flow diversion excellence worldwide with high rates of complete occlusion, optimal wall apposition, backed by our legacy of innovation as the pioneer of the world’s first surface modified flow diverter with 10 year follow up data4. See how Pipeline™ and Shield™ devices have evolved over the years from the perspective of a healthcare professional and an engineer:

Healthcare professional

Watch Prof. Hal Rice talk through his journey of Pipeline™ through the generations.

Engineer

Watch Medtronic Engineering Director Evan Epstein walk through the evolution of the Pipeline™ and Shield™ devices 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

PUF 5yr follow up 

Long term efficacy & safety 95.2% occlusion, no major strokes1

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 standardised methodology7

2025

Bold decision

Vantage™ 027 recall & commitment to investigate & resolve Braid deformation

Excellence driven by data

With more than 900 studies worldwide3, the Pipeline™ Embolization family is driving the forefront of clinical evidence. We have a wide range of quality clinical studies demonstrating consistently high complete occlusion & good safety profile featuring the Medtronic Pipeline™ and Shield™ products. 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
Combined

Mortality
Combined

SHIELD Study  |  Real world performance9

Study Design

Setting:
Prospective, post market, multi-centre study
Hospitals
21
Patients
205
Aneurysms
Intracranial Aneurysms

Complete Occlusion
At 18 months

Morbidity
Combined

Mortality
Combined

PREMIER Study  |  Real world performance10

Study Design

Setting:
Prospective, single-arm trial
Patients
141
Aneurysms
Unruptured wide-necked 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
  3. Data on file; TR-NV11820 Rev T
  4. PMA #s P100018, P100018-S026, and P100018-S034
  5. PUFs Becske, T., Brinjikji, W., Potts, M. B., Kallmes, D. F., Shapiro, M., Moran, C. J., Levy, E. I., McDougall, C. G., Szikora, I., Lanzino, G.,Woo, H. H., Lopes, D. K., Siddiqui, A. H., Albuquerque, F. C., Fiorella, D. J., Saatci, I., Cekirge, S. H., Berez, A. L., Cher, D. J., Berentei, Z.,… Nelson, P. K. (2017). 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, 80(1), 40–48. https://doi.org/10.1093/neuros/nyw014.
  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 et al. J Neurointerv Surg. 2024 Jun 2:jnis-2023-021404. doi: 10.1136/jnis-2023-021404.
  8. SCOPE-AUS, Ghim Song Chia, Laetitia de Villiers, Vinicius Carraro do Nascimento, Cheryl Lee Rapier, Maame Amma Owusu, Fiona S. Lau, Alexander McQuinn, Cameron Williams, Justin Whitley, Andrew Cheung, Nathan W. Manning and Hal Rice. Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort (SCOPE-AUS), June 2022 STROKE: Vascular and Interventional Neurology2(5) DOI: 10.1161/SVIN.121.000292
  9. SHIELD Hal Rice, Mario Martínez Galdámez, Markus Holtmannspötter, Laurent Spelle, Konstantinos Lagios, Maria Ruggiero, Pedro Vega, Hemant Sonwalkar, René Chapot, Saleh Lamin, Hal Rice, Mario Martínez Galdámez, Markus Holtmannspötter, Laurent Spelle, Konstantinos Lagios, Maria Ruggiero, Pedro Vega, Hemant Sonwalkar, René Chapot, Saleh Lamin, June 2020 Journal of Neurointerventional Surgery12(11):neurintsurg-2020-015943 DOI: 10.1136/neurintsurg-2020-015943,
  10. PREMIER, Ricardo A Hanel, Gustavo M Cortez, Demetrius Klee Lopes, Peter Kim Nelson, Adnan H Siddiqui, Pascal Jabbour, Vitor Mendes Pereira, Istvan Szikora István, Osama O Zaidat, Chetan Bettegowda, Geoffrey P Colby, Maxim Mokin, Clemens M Schirmer, Frank R Hellinger, Curtis Given, Timo Krings, Philipp Taussky, Gabor Toth, Justin F Fraser, Michael Chen, Ryan Priest, Peter Kan, David Fiorella, Donald Frei, Beverly Aagaard-Kienitz, Orlando Diaz, Adel M Malek, C Michael Cawley, Ajit S Puri, David F Kallmes. 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, JULY 2019, JOURNAL OF NEUROINTERVENTIONAL SURGERY; 12:62–66. DOI: 10.1136/https://jnis.bmj.com/content/neurintsurg/early/2022/03/14/ neurintsurg-2021-018501.full.pdf
  11. D01295063 Rev. B

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