Alert Indications, Safety and Warnings

PIPELINE™ FLEX EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY™ Flow Diverters

Shield Technology™ builds on the clinically proven treatment of certain wide-necked intracranial aneurysms with the Pipeline Flex™ embolization device, by introducing an innovative implant surface modification, designed to advance flow diversion therapy.1,2

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Alert Indications, Safety and Warnings

Overview

SHIELDED BY SCIENCE.

SHIELD TECHNOLOGY™

Shield Technology™ is designed to improve the hemocompatibility2,3 and deliverability4 of the Pipeline™ implant by integrating synthetic phosphorylcholine (PC) to the surface of the braid.

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PRODUCT DETAILS

Reduces Material Thrombogenicity2,3

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Human Blood Loop Model Results2

Pipeline™ Flex Shield Technology™ addresses one of the common barriers to the flow diversion therapy: material thrombogenicity. Through covalently bonding PC to the surface of the implant, the Shield Technology™ surface modification enhances Pipeline™ Flex to achieve a scientifically proven reduction in implant material thrombogenicity.2,3*

*Data derived from the referenced bench studies and may not be representative of clinical performance.

Improves Performance4

Shield Technology™ also improves the customer experience through improvements in delivery and resheathing force through tortuousity.4

Delivery Force (N): 

Illustrated graph displaying delivery force statistics with and without Flex technology

Resheathing Force (N): 

Illustrated graph displaying resheating force statistics with and without Flex technology

*Data derived from the referenced bench studies and may not be representative of clinical performance.

Close-up image of the Pipeline Flex product from Medtronic
Close-up image of the Pipeline Flex product with Shield Technology

The modified surface of the implant exhibits hydrophilic properties, decreasing delivery and resheathing forces by 20% and 12% respectively.4*

Phenom™ 27 Catheter

The Phenom™ 27 Catheter, specifically designed for flow diversion, incorporates a hybrid coil-braid design to maintain stability and improve procedural performance.5

Learn More

SHIELDED BY SCIENCE.

Illustration of the Pipeline Flex product with Shield Technology

Most Studied Flow Diverter Worldwide

Pipeline™ is the most studied flow diverter worldwide with a proven safety and efficacy profile.6,7

See clinical evidence
Map showing 9 Pipeline Flex clinical study locations around the world, including North America, South America, Europe, Asia, and Australia.

SPECIFICATIONS

INDICATIONS FOR USE

The Pipeline™ Flex Embolization Device with Shield Technology™ is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

CAUTION: Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician. Indications, contraindications, warnings and instructions for use for the Pipeline™ Flex Embolization Device with Shield Technology™ can be viewed at https://www.medtronic.com/manuals.

INSTRUCTIONS FOR USE (IFU)

View full instructions for use.

Pipeline™ Shield IFU
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QUESTIONS FOR OUR TEAM?

Whether you're looking for procedural support, or additional information on our products and solutions — our team is here to help.

CONTACT US
1

Medtronic Internal Report FD3456B, PUFS 5 Year CSR.

2

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.

3

Medtronic Internal Study, D00422708 Rev. A, Competitive Test Report - Material Thrombogenicity Evaluation of Flow Diversion Devices.

4

Medtronic Internal Study, TR-NV11991 Rev. B, Performance Evaluation of the Pipeline Flex Embolization Device with Shield Technology.

5

Medtronic Internal Study, TR-NV15405 Rev. A, Micro-Catheter Compatibility Verification of Pipeline Flex with Shield Technology

6

Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A second-generation, endoluminal, flow-disrupting device for treatment of saccular aneurysms. AJNR AmJ Neuroradiol. 2009;30(6):1153-1158.

7

Scientific Communication Document search (2018) showing clinical summaries. No other studies meet these criteria.