PIPELINETM FLEX WITH SHIELD TECHNOLOGYTM Flow Diverters
Pipeline™ is the reference in flow diversion, grounded by 10 years of experience and the highest number of clinical studies.1 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™ Flex with Shield Technology™
Legacy of the Pipeline™ flow diverters, this third generation of flow diverters offers an alternative solution for the treatment of aneurysms.
This device is made of 48 braids: 36 cobalt-chromium and 12 platinum wires for radiopacity.
PRODUCT DETAILS
SHIELD TECHNOLOGY™
Shield Technology™ is designed to improve the hemocompatibility and deliverability of the Pipeline™ implant by addressing material thrombogenicity.2
It is a surface modification where synthetic phosphorylcholine (PC) polymer is covalently-chemically-bonded to the strands that make up the Pipeline™ device braid.
It provides biomimicry properties the blood cells won’t react to the Pipeline™ implant.3-12
FEWER thrombogenic RISKS
Significant reduction of thrombin peak and time to peak.13
60%
lower peak thrombin with Shield™, compared to Silk.14
60%
Higher time to peak thrombin with Shield™, compared to Silk.14
55%
lower peak thrombin with Shield™, compared to Fred and Pipeline™ Flex.14
45%
Higher time to peak thrombin with Shield™, compared to Fred.14
PFLEX STUDY
Initial clinical data shows that Pipeline™ Flex with Shield Technology™ is safe and effective for the treatment of intracranial aneurysms.
0%
Target aneurysm recurrence15
0%
Target aneurysm recurrence15
0%
Major stroke in the territory supplied by the treated artery15
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
DEVICE MANUAL
The Pipeline™ Flex embolization device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms.
See the device manualANY QUESTIONS?
Do you need support for procedures? Or information on our products and solutions?
Our team is happy to help answer any questions you may have.
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1
Number of studies including Pipeline: 48 as of June 2019
2
Medtronic Study Performance Evaluation of PipelineTM Flex Embolization Device with Shield TechnologyTM. 12 September 2014. TR-NV11991 Rev. B
3
Lewis, A.L. and P.W. Stratford, Phosphorylcholine-coated stents. J Long Term Eff Med Implants, 2002, 12(4): p. 231-50
4
Lewis, A.L. et al., Crosslinkable coatings from phosphorylcholine-based polymers. Biomaterials, 2001. 22(2): p 99-111.
5
Whelan, D.M. et al., Biocompatibility of phosphorylcholine coated stents in normal porcine coronary arteries. Heart, 2000. 83(3): p. 338-45.
6
Kuiper K.K. et al., Phosphorylcholine-coated metallic stents in rabbit iliac and porcine coronary arteries. Scand Cardiovasc J, 1998. 32(5): p. 261-8
7
Chen C. et al., Phosphorylcholine coating of ePTFE grafts reduces neointimal hyperplasia in canine model. Ann Vasc Surg, 1997. 11(1): p. 74-9
8
Zheng H et al., Clinical experience with a new biocompatible phosphorylcholine-coated coronary stent. The Journal of invasive cardiology, 608-614 (1999)
9
Galli M. et al. Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent. The Journal of invasive cardiology 12, 452-458 (2000).
10
Grenadier E et al., Stenting very small coronary narrowings (<2mm) using the biocompatible phosphorylcholine-coated coronary stent. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 55, 303-308 (2002)
11
Boland J.L. et al. Multicenter evaluation of the phosphorylcholine-coated biodivYsio stent in short de novo coronary lesions: The SOPHOS study. International journal of cardiovascular interventions 3, 215-225, doi:10.1080/14628840050515966 (2000)
12
Beaudry Y, Sze S, Fagih B, Constance C & Kwee R, Six-month results of small vessel stenting (2.0-2.8mm) with the Biodivysio SV stent. The journal of invasive cardiology 13, 628-631 (2001).
13
Matsuda Y. et al. Analysis of neointima development in flow diverters using optical coherence tomography. JNIS. 2017
14
Girdhar G. Li J. Kostousov L. et al. J Thromb Thrombolysis 2015;40:437. https://doi.org/10.1007/s11239-015-1228-0
15
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.uk