Healthcare Professionals

Pipeline Flex Embolization Device

Aneurysm Flow Diversion

Overview

The clinically proven¹ 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.2,3

INDICATIONS

The Pipeline Flex embolization device 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.

PRODUCT DETAILS

Features

The technical features of the Pipeline embolization device support a safe and highly effective procedure.2

  • 48-strand braided mesh design and a soft low profile distal tip4 for flexible conformability
  • 75% cobalt chromium / 25% platinum tungsten for radial force and uniform radiopacity
  • 30-35% surface coverage at nominal diameter⁵
  • Trackable through tortuosity, enabling better vessel deflection and allowing for a controlled distal landing zone4
  • Fully resheathable and can be repositioned and redeployed up to two times6

Aneurysm Flow Diversion with Pipeline Flex Device

View an animation of aneurysm flow diversion with the Pipeline Flex embolization device.

Clinical Outcomes*

The PUFs study was a multi-center, prospective, interventional, single-arm trial to evaluate the safety and effectiveness of the Pipeline implant in the treatment of complex intracranial aneurysms.

PUFs studied 108 patients with a wide-necked, large, or giant intracranial aneurysm in the petrous, cavernous, or paraophthalmic regions of the internal carotid artery.

  • 0% recurrence of aneurysms after complete occlusion¹
  • 0% major ipsilateral stroke or neurological death from 6 months to 5 years (5.6% M&M at 6 months)¹
  • 95% occlusion at 5 years follow-up¹
  • For treatment success, target aneurysm had to be 100%  occluded

Ancillary Devices

See the Neurovascular Product Catalog for information about these related products.

  • Marksman™ Micro Catheter
  • Navien™ intracranial support catheter

MANUALS AND TECHNICAL MANUALS

Pipeline Flex Embolization Device Instructions for Use

This technical manual includes indications, warnings, precautions, device sizes, instructions, MRI information, and clinical study summary. Find in the product labeling supplied with each device or call Medtronic at 800-961-9055.

MODEL SPECIFICATIONS

See the Neurovascular Product Catalog.


*

The PUFS study only included the Pipeline embolization device. The Pipeline Flex embolization device contains the same implant as the Pipeline embolization device.


References

1

Medtronic Internal Report FD3456B, PUFS 5 Year CSR

2

Becske T. et al., Pipeline for Uncoilable or Failed Aneurysms. Results from a Multicenter Clinical Trial. Radiology. Published online Feb 15, 2013

3

Kallmes, DF et al. International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study, AJNR Published online, Oct 29, 2014

4

Medtronic Internal Report TR-NV10931/TR-NV11121

5

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.

6

Medtronic Internal Report TR-NV11534/TR-NV11121.