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

ACCEPT NO SUBSTITUTE.

Pipeline™ Flex

DEVELOPING THE THERAPY

Since 2011, we’ve been the leader in flow diversion — disrupting aneurysm treatment, advancing the practice and raising the standard care. Medtronic is consistently committed to innovative technology and comprehensive, collaborative support.

Our experienced, consultative field team is at the ready with support for your U.S. 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.

Product details

SAFETY IN NUMBERS

The Pipeline™ Flex embolization device (Pipeline™ Flex) provides reliable safety across multiple aneurysm types.1,4,5

Primary safety endpoint results at 1 year:

  • PREMIER Study4 — 2.1% 
  • PUFs Study1,5 — 5.6%

PREMIER: The primary safety endpoint was incidence of major stroke (ischemic or hemorrhagic) in the territory supplied by the treated artery (defined as an increase of 4 points on the National Institute of Health Stroke Scale (NIHSS)) or neurologic death within 1 year after treatment.

PUFs: The primary safety endpoint of the PUFS study was the incidence of major ipsilateral stroke (defined as an increase of ≥4 points on the NIHSS and present after 7 days as adjudicated by the Clinical Events Committee) or neurological death within 180 days of Pipeline™ embolization device placement.

TIME-TESTED EFFICACY

Pipeline™ Flex achieves reliable efficacy across multiple aneurysm types at 1 year5 and out to 5 years.1,6*

Primary effectiveness endpoint results at 1 year:

  • PREMIER Study4 — 76.8% 

Long term complete occlusion rates:

  • PUFs Study1,5 — 95%  at 5 years with 0% recurrence

PREMIER: The primary effectiveness endpoint of the study was complete aneurysm occlusion of the target aneurysm without major stenosis (≤ 50%) of the parent artery or retreatment of the target aneurysm at one year post-procedure, as adjudicated by an independent core laboratory (“Core Lab”), or retreatment of the target intracranial aneurysms (IA) one year post-procedure.

PUFs: The primary effectiveness endpoint of the study was complete occlusion of the aneurysm without major (>50%) stenosis of the parent artery or adjunctive use of complimentary embolic agent as seen on 180-day angiography and judged by the independent core research lab (CRL).

*Data based on follow up images available.

TRUSTED POSITIONING

The design and material properties of Pipeline™ Flex lead to uniform wall apposition.7 When delivered through the Phenom™ 27 catheter, specifically designed for flow diversion,8 system stability is optimized.9

View of the Pipeline Flex braid wall apposition.

Pipeline™ Flex Wall Apposition

Internal Bench Top Study7 PED-300-30 in 3mm vessel.

PIPELINE™ FLEX TECHNICAL FEATURES

The technical features of Pipeline™ Flex support a safe and highly effective procedure.2

  • 48-strand braided mesh design and a soft low profile distal tip10 for flexible conformability
  • 75% cobalt chromium / 25% platinum tungsten for radial force and uniform radiopacity11
  • 30-35% surface coverage at nominal diameter12
  • Trackable through tortuosity, enabling better vessel deflection and allowing for a controlled distal landing zone10
  • Fully resheathable and can be repositioned and redeployed up to two times10

INVESTING IN EVIDENCE-BASED MEDICINE

Pipeline™ Flex is the most studied flow diverter worldwide with a proven safety and efficacy profile.12,13

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

PREMIER4
n=141

INTREPED3
n=793

ASPIRE15
n=191

BEUNOS AIRES EXPERIENCE16
n=53

PUFS1
n=107

PITA17
n=31

ANKARA EXPERIENCE18
n=191

HONG KONG EXPERIENCE19
n=143

AUSTRALIAN REGISTRY20
n=54

*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.

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.21

Learn about sim&cure
Image showing the pipeline flex flow diverter.

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

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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 wide-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.

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, Hanel R, Lopes D, et al. International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol 2015;36:108–115.

4

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

5

Becske T. et al., Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial., (JNS) Neurosurgery Published online Jan 9, 2017.

6

PMA-P100018-S015

7

TR-NV11601 Rev. A

8

71062-001 Rev. A

9

ML-0001 Rev. B

10

TR-NV11121 Rev. D

11

SA-00008-XX Rev. H

12

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.

13

PMA- P100018-S011

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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.