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 certain wid-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
The Pipeline Flex embolization device 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.
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 - (02:40)
View an animation of aneurysm flow diversion with the Pipeline Flex embolization device.
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CLINICAL OUTCOMES
PREMIER STUDY
The PREMIER study is the first prospective, multi-center trial to evaluate the use of the Pipeline Flex* device for the treatment of small and medium, unruptured aneurysms of the intracranial carotid and proximal vertebral arteries. The findings from the PREMIER study provide evidence that treatment of wide-necked, small and medium intracranial aneurysms measuring ≤ 12 mm located in the ICA (up to the terminus) and proximal vertebral artery segment up to and including the posterior inferior cerebellar artery treated with the Pipeline™ device results in:7
- 95.9% attempted device success rate
- 76.7% complete occlusion without significant parent artery stenosis or retreatment
- 2.2% major stroke or neurological death
- 2.9% retreatment
- Zero aneurysm recurrences at 1-year post-procedure
PUFS TRIAL
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 for patients with follow-up¹
- For treatment success, target aneurysm had to be 100% occluded
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
*
The PREMIER study included the Pipeline Embolization Device and Pipeline Flex Embolization Device. The Pipeline Flex Embolization Device contains the same implant as the Pipeline Embolization Device.
†
The PUFs study only included the Pipeline embolization device. The Pipeline Flex embolization device contains the same implant as the Pipeline embolization device.
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.
7
PREMIER Clinical Study Report Medtronic FD3563, mITT population, Rev B. 12-SEP-2018
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 can be found in the product labeling supplied with each device.