Alert Indications, Safety and Warnings

Pipeline™ Flex  Embolization Device

The clinically proven¹ Pipeline™ Flex embolization device redefines treatment for certain wide-necked intracranial aneurysms by diverting flow away from the aneurysm neck, reconstructing the parent artery and restoring its natural course.2,3

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Alert Indications, Safety and Warnings

Overview

TIME-TESTED EFFICACY. UNCOMPROMISING CARE.

Pipeline™ Flex
Accept No Substitute

Product details

The technical features of the Pipeline™ Flex embolization device (Pipeline™ Flex) 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 radiopacity17
  • 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 times4 

DEVELOPING THE THERAPY

Since 2011, we’ve been the leader in flow diversion—developing the therapy, advancing the practice and raising the standard care. Consistently committed to innovative technology and comprehensive, collaborative support. 

Our experienced, consultative field team is at the ready with support for your US flow diversion procedures and targeted physician education programs. With our time-tested technology and uncompromising service, we are your partner for treating our aneurysm patients.

INVESTING IN RESEARCH

Pipeline™ Flex is the most studied flow diverter worldwide with a proven safety and efficacy profile8,9

device studies
device studies

ADVANCING 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. PREMIER studied 141 patients and findings 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 at 1-year post-procedure
  • 2.2% major stroke or neurological death at 1-year post-procedure
  • 2.9% retreatment at 1-year post-procedure
  • Zero aneurysm recurrences at 1-year post-procedure
Premier Study Data for Pipeline Flex

PUFS TRIAL*

The PUFs† study was a multi-center, prospective, interventional, single-arm trial to evaluate the safety and effectiveness of the Pipeline™ device 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
PUFs Study Data for Pipeline Flex Device

SIM&CURE

We’ve partnered with Sim&Cure to bring you a pre-operative planning software platform that helps you computationally model and plan your Pipeline™ Flex embolization device procedures.18

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ANY 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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INDICATIONS FOR USE6

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.

CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

*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-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

PMA-P100018-S015

7

PREMIER Clinical Study Report Medtronic FD3563, mITT population, Rev B. 12-SEP-2018

8

PMA- P100018-S011

9

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

10

Pipeline Flex Sales Training Data on File.

11

Kallmes DF, et al., Aneurysm Study of Pipeline in an Observational Registry (ASPIRe), Interv Neurol. (JVIR) June 2016.

12

Lylyk P1, Miranda C, Ceratto R, Ferrario A, Scrivano E, Luna HR, Berez AL, Tran Q, Nelson PK, Fiorella D. Curative Endovascular Reconstruction of Cerebral Aneurysms with the Pipeline Embolization Device; The Buenos Aires Experience. Neurosurgery. 2009 Apr;64(4):632-42

13

Nelson, P.K., et al., The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial. AJNR Am J Neuroradiology, 2010: p. ajnr.A2421

14

Saatci, Cekirge, et al., Pipeline Flow-Divertor Embolization Device: A Single-Center Experience with Long-Term Follow-Up Results. Published July 19, 2012 as 10.3174/anjr.A3246

15

Yu, et al. Intra-cranial aneurysms: Midterm outcome of Pipeline Embolisation Device – A Prospective Study in 143 Patients with 178 Aneurysms. Radiology 2012

16

W. McAuliffe, V. Wycoco, H. Rice, C. Phatouros, T.J. Singh, J. Wenderoth. Immediate and Midterm Results Following Treatment of Unruptured Intracranial Aneurysms with the Pipeline Embolization Device AJNR Am J Neuroradiology, 2012 Published October 6, 2011 as 10.3174/ajnr.A2727

17

SA-00008-XX

18

Sim&Cure FDA 510(k) K190049 clearance on September 17, 2019. Sim&Size is contraindicated for giant aneurysms. Refer to Sim&Size User Manual for complete indications for use, contraindications, warnings and instructions for Use.