Pipeline™ Flow Diverter

NVTV

What is Shield Technology™?

A surface modification, which mimics red blood cell chemistry to:

  1. Reduce thrombogenicity, reduce the risk of clot formation caused by the device, with the aim to prevent stroke1,3
  2. Promote endothelisation to form earlier & more neointima with less hyperplasia without compromising occlusion rates4,5

What makes Shield Technology™ different? 

Unlike other Flow Diverters with surface coatings, Shield Technology™ is just 3mm thick (~0.01% of one braid wire)6, designed not to further disrupt blood flow.9 

Shield Technology™ proven
to reduce thrombogenicity1,3

Shield Technology™ is designed to improve the haemocompatibility and deliverability of the Pipeline™ implant by addressing material thrombogenicity.​

Preclinical models show reductions in:1,3​

  • Thrombin formation  ​
  • Platelet deposition​
  • Clot formation​
  • Intimal hyperplasia without affecting aneurysm occlusion or endothelialisation
See the data (open in new window)

Shield Technology™ reduces the risk of clot formation caused by the device, with the aim to prevent stroke7,8

Coagulation14

Platelet activation15

µg/mL

Peak Thrombin16

nM

Human blood loop model

Actual images show the 94% less platelet activation with Shield Technology™

Shield Technology™ proven to promote endothelization4,5

Our Surface modified Cobalt Chromium flow diverters induce less neointimal hyperplasia without reducing occlusion rates

No Shield Technology™

Placing a Flow Diverter without a surface modification may lead to increase neointimal hyperplasia4,5

Shield Technology™

Has been shown to lead to earlier and more even neointima formation with less hyperplasia4,5

Pipeline™ Flex with
Shield Technology™

The clinically proven11 Pipeline™ Flex device redefines treatment for large or giant wide-necked intracranial aneurysms by diverting flow away from the aneurysm neck, reconstructing the parent artery and restoring its natural course.12,13 

References:

  1. Medtronic Internal Study, D00422708 Rev. A, Competitive Test Report - Material Thrombogenicity Evaluation of Flow Diversion Devices.
  2. TR-NV11011 Rev C
  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. 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.
  5. 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.
  6. TR-NV11011 Rev C
  7. Platelet Activation and Factors for Clot Formation https://youtu.be/R8JMfbYW2p4?si=05Oi7V1F1PVLnzSH
  8. 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.
  9. 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.
  10. 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.
  11. Medtronic Internal Report FD3456B, PUFS 5 Year CSR
  12. Becske T. et al., Pipeline for Uncoilable or Failed Aneurysms. Results from a Multicenter Clinical Trial. Radiology. Published online Feb 15, 2013
  13. Kallmes, DF et al. International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study, AJNR Published online, Oct 29, 2014
  14. Platelet Activation and Factors for Clot Formation https://youtu.be/R8JMfbYW2p4?si=05Oi7V1F1PVLnzSH ​ 
  15. 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.​ 
  16. 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.

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