Pipeline™ Vantage and Flex Flow Diverters
The Pipeline™ embolization device portfolio offers high occlusion rates, optimal wall apposition, and proven long-term outcomes—backed by 10 years of data and a legacy of innovation as the first surface-modified flow diverter.1-4
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Overview
Pioneering
Unrivalled legacy of innovation1, 5, 6, 7
>100k
Shield devices implanted8
Efficacy
Setting the bar for safe & effective treatment2, 8, 9
>50k
Patients studied worldwide8
Versatility
Tailored treatment with a wide range of sizes6
Right size device
Efficacy, safety, & braid change
Connections for Life
Supporting you to advance Neurovascular care
Partnering
Beyond quality products
Pioneering Unrivalled legacy of innovation1,5,6,7
Medtronic have been the pioneers in Flow Diversion for over 15 years with more than 100K Shield devices have been implanted8
Shield Technology™
Our Pipeline™ embolization devices include our world-renowned Shield Technology™ which is surface modification, designed to mimic red blood cells to reduce thrombogenicity & promote endothelisation without disrupting blood flow10-14
Shield Technology™ addresses one of the common barriers to flow diversion therapy: material thrombogenicity. Through covalently bonding Phosphorylcholine to the surface of the Flow diverter. The surface modification has been scientifically proven to reduce the risk of clot formation caused by the device, with the aim to prevent stroke15-17
Efficacy Setting the bar for safe & effective aneurysm treatment
Our Pipeline Embolization Device Family consistently achieves high complete occlusion rates and low adverse events, supported by extensive clinical data from large-scale studies and the legacy of the most studied flow diverter franchise.2
INSPIRE A data
Our world renowned Independent, core lab adjudicated registry demonstrates efficacy & safety performance of our Pipeline portfolio.
>75% complete occlusion & strong safety profile in real world across the portfolio18
Pipeline™ Flex with Shield Technology™
Pipeline™ Vantage with Shield Technology™
Versatility Tailored treatment with a wide range of sizes6
Our Pipeline Embolization Device Family consists of our Pipeline Flex with Shield Technology and our Pipeline Vantage with Shield Technology device range.
Our portfolio provides a comprehensive size range from 2.50mm to 5.00mm diameters in 0.25mm increments and lengths up to 35mm.6 Thus, providing tailored treatment options for diverse patient anatomies.
The importance of “right size device“ is critical when considering efficacy, safety, and braid change.19
Pipeline™ Embolization portfolio overview
| Characteristic | Pipeline™ Vantage 021 |
Pipeline™ Flex with Shield Technology™ |
|---|---|---|
| Intended use | ||
| Size | 2.50mm to 3.50mm diameters in 0.25mm increments and lengths up to 25mm | 2.50mm to 5.00mm diameters in 0.25mm increments and lengths up to 35mm |
| Design⁶ | ||
| Wire design | Integrated wire design, Drawn Filled Tubes (DFT) with Cobalt-Chromium shell + platinum core |
Separate monofilaments 75% Cobalt-Chromium 25% platinum-tungsten |
| Number of wires | 48 | 48 |
| Braid angle | 48º | 47º* |
| Microcatheter compatibility | 021 | 027 |
| Clinical performance¹⁸ | ||
| Complete Occlusion rate | 75.3% (58/77) | 75.5% (315/417) |
| Death | 0.9% (1/110) | 2.1% (11/530) |
| Major stroke | 1.8% (2/110) | 2.5% (13/530) |
| Brain deformation | 3.64% (4/110) | 5.85% (31/530) |
How to deliver the device? Our Flow Diverter access portfolio
Phenom™ 21 & 27 microcatheters
To deliver Pipeline device with minimal friction20-22:
- Rounded distal tip to enhance trackability over-the-wire and support device resheathing
- Provides proximal support and prevent ovalization (kinking) at transitions
- Enables access to tortuous anatomy
Phenom™ Plus catheter
Designed to facilitate access in tortuous anatomies20,23:
- 4.2F Distal OD low profile and highly trackable support system
- Superior pushability
Navien™ 5F & 6F Intracranial support catheter
Medtronic proprietary flat wire technology design to ensure24:
- Large ID among 5/6 Fr catheters
- Optimal trackability
- Resistance to ovalization
Rist™ Radial Access Catheter
The first guide catheter designed for radial pathway25-33
- Atraumatic tip design
- Transition zones for optimal distal trackability gradual proximal stability
*
At the time of publication in June 2023. See medtronic.com/vantagedata
1
A. Rouchaud, C. Ramana, W. Brinjikji, Y.-H. Ding, D. Dai, T. Gunderson, J. Cebral, D.F. Kallmes, R. Kadirvel Wall Apposition Is a Key Factor for Aneurysm Occlusion after Flow Diversion: A Histologic Evaluation in 41 Rabbits. American Journal of Neuroradiology Nov 2016, 37 (11) 2087-2091; DOI: 10.3174/ajnr.A4848
2
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.
3
Data on file; TR-NV11991 Rev B
4
Pipeline™ Vantage device IFU; M069725CDOC2_A. Pipeline™ Flex device IFU; M066940CDOC2_A
5
Data on file; M993575ADOC1 Rev B
6
Medtronic sales data on file
7
Data on file; TR-NV11820 Rev T
8
Medtronic Internal Study, D00422708 Rev. A, Competitive Test Report - Material Thrombogenicity Evaluation of Flow Diversion Devices.
9
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.
10
Matsuda Y, Chung J, Lopes DK. Analysis of neointima development in flow diverters using optical coherence tomography imaging Journal of NeuroInterventional Surgery 2018;10:162-167.
11
Caroff J, Tamura T, King RM, et al Phosphorylcholine surface modified flow diverter associated with reduced intimal hyperplasia Journal of NeuroInterventional Surgery 2018;10:1097-1101.
12
TR-NV11011 Rev C
13
Platelet Activation and Factors for Clot Formation https://youtu.be/R8JMfbYW2p4?si=05Oi7V1F1PVLnzSH
14
Gaurav Girdhar, Samantha Ubl, Reza Jahanbekam, Sinduja Thinamany, Anna Belu, John Wainwright, Michael F. Wolf, Thrombogenicity assessment of Pipeline, Pipeline Shield, Derivo and P64 flow diverters in an in vitro pulsatile flow human blood loop model,eNeurologicalSci,Volume 14,2019,Pages 77-84,ISSN 2405-6502,https://doi.org/10.1016/j.ensci.2019.01.004.
15
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.
16
D01295063 Rev. B
17
PMA #s P100018, P100018-S026, and P100018-S034
18
PEDESTRIAN - Lylyk I, Scrivano E, Lundquist J, Ferrario A, Bleise C, Perez N, Lylyk PN, Viso R, Nella-Castro R, Lylyk P. Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms, Single-Center Registry: Long-Term Angiographic and Clinical Outcomes from 1000 Aneurysms. Neurosurgery. 2021 Aug 16;89(3):443-449. doi: 10.1093/neuros/nyab183. PMID: 34098575; PMCID: PMC8374967.
19
D01295063 Rev. B
20
F. Mut, J.R. Cerebral Effects of Flow-Diverting Device Oversizing on Hemodynamics Alteration in Cerebral Aneurysms American Journal of Neuroradiology Nov 2012, 33 (10) 2010-2016; DOI: 10.3174/ajnr.A3080
21
Data on file. TR-NV12653 Addendum 1 Rev A
22
Data on file. TR-NV13342 Addendum 3 Rev A
23
Data on file. TR-NV15405 Rev A
24
45. Data on file. ML-0001.B
25
DWGS50650 Rev H, DWGS50651 Rev K
26
Based on internal test report TR-14569, 6F Radial Access Guide Catheter Verification Report (t=0). Rev 02.
27
Rist 071 Radial Access Guide Catheter 510K clearance #K211990. July 2021.
28
Rist Radial Access Catheter 510(k) clearance #K200417. May 2020.
29
Based on internal test report TR-14609, 6F Radial Access Guide Catheter Benchtop Validation Report. Rev 02.
30
Rist Radial Access Catheter 510K clearance #K201682. September 2020.
31
Rist Cath Radial Access Long Sheath 510K clearance #K191551. December, 2019.
32
Based on internal test report TR-13523, RIST Radial Access Catheter Benchtop Validation Report. Rev 00.
33
Based on internal test report TR-13494, 5.5F Access Catheter t=0 Verification Report. Rev 01.
34
Based on internal test report TR-12736, Nova Benchtop Validation Report. Rev 00.
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