Pipeline™ Flow Diverter

Pipeline™ Flow Diverter

NVTV

>100K

Patients treated with Shield Technology™²

>58K

Studied in over 58K patients worldwide³

>1K

Studied in more than 1,000 publications worldwide³

Pioneers of flow diversion

Medtronic has been a pioneer in flow diversion for over 15 years with more than 100K patients treated with Shield Technology™. We have set the benchmark in flow diversion excellence worldwide with high rates of complete occlusion, optimal wall apposition and backed with a legacy of innovation as the world's first surface modified flow diverter with 10-year follow up data⁴. See how the Pipeline™ Embolization Device Family has evolved over the years from the perspective of a healthcare profession and a Medtronic engineer:

Healthcare professional

Hear from Prof. Hal Rice on his journey with the Pipeline™ Family through the generations.

Engineer

Discover more with Medtronic Engineering Director, Evan Epstein, as he talks through the evolution of the Pipeline™ Family from an engineer's lens.

History of Pipeline

2008

Pioneered the World's First Flow Diverter

2016

INSPIRE A

Worlds first post market surveillance registry for new technology

2017

PUFS 5yr follow up

Long term efficacy & safety 95% occlusion, no major strokes⁵

2020

Post Market registry

First society endorsed post market registry INSPIRE A

The Worlds first Core Lab adjudicated PMCF

INSPIRE A, Ensuring robust & independent assessment

INSPIRE A - Clinical Events Committee (CEC)

Ensuring robust & independent assessent

2023

First & only 10yr follow up study

100% Complete occlusion rate⁶

Braid deformation clinical reporitng standards

Drove the first society endorsed
standardized methodology⁷

2025

Bold decision

A committment to Braid Deformation exploration and resolution.

Excellence driven by data

With more than 1,000 studies worldwide³, the Pipeline™ Embolization family is driving the forefront of clinical evidence. We have a wide range of clinical studies demonstrating consistently high complete occlusion and good safety profile featuring the Medtronic Pipeline™ Embolization Device Family. Explore the data below:

SCOPE AUS Study results
SHIELD Study results
PREMIER Study results
INSPIRE A Study results
Monteiro Study Results

SCOPE AUS Study | Real world performance⁸

Study Design

Setting:
Multi-center, single-arm, retrospective study
Aneurysms treated
278
Patients
238
Aneurysms
Unruptured Intracranial Aneurysms

See the data (open in new window)

Overall Occlusion
At 18 months

Morbidity
Unruptured ICA aneurysms

Mortality
of unruptured ICA aneurysms

SHIELD Study | Real world performance⁹

Study Design

Setting:
Prospective, post market, multi-centre study
Hospitals
21
Patients
204
Aneurysms
Intracranial Aneurysms

See the data (open in new window)

Complete Occlusion
At 12 months

Morbidity
Combined

Mortality
Combined

PREMIER Study | Real world performance¹⁰

Study Design

Setting:
Prospective, single-arm trial
Patients
141
Aneurysms
Unruptured wide necked small and medium intracranial aneurysms

See the data (open in new window)

Complete Occlusion
At 3 years

Combined safety endpoint
At 3 years

Primary effectiveness endpoint
At 3 years

INSPIRE A Study | Real world performance¹¹

Study Design

Setting:
Real-world, observational, prospective, multi-center registry
Hospitals
40
Patients
700
Aneurysms
Intracranial aneurysms

See the data (open in new window)

Overall Occlusion
(315/417)
Last follow-up, DSA only

Major Stroke
(13/530)

Mortality
(11/530)

Monteiro et al | Real world performance⁶

Study Design

Setting:
Retrospective review
Aneurysms treated
92
Patients
83
Aneurysms
Intracranial Aneurysms

See the data (open in new window)

Complete Occlusion
At 10 years
(15/15)

Retreatment
At 10 years
(1/15)

Treatment related complications
Nonfatal

⁺CL-011484

Elarjani T, Almutairi OT, Bafaquh M, Alturki AY. Bibliometric Analysis of the Top 100 Most-Cited Articles on Intracranial Flow Diversion. World Neurosurg. 2021 Feb;146:e618-e630. doi: 10.1016/j.wneu.2020.10.150. Epub 2020 Nov 2. PMID: 33152498.
Medtronic sales data on file; CL-020424
Data on file; TR-NV11820 Rev W
PMA #s P100018, P100018-S011, P100018-S026 and P100018-S034
Becske T, Brinjikji W, Potts MB, Kallmes DF, Shapiro M, Moran CJ, Levy EI, McDougall CG, Szikora I, Lanzino G, Woo HH, Lopes DK, Siddiqui AH, Albuquerque FC, Fiorella DJ, Saatci I, Cekirge SH, Berez AL, Cher DJ, Berentei Z, Marosfoi M, Nelson PK. 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. Neurosurgery. 2017 Jan 1;80(1):40-48. doi: 10.1093/neuros/nyw014. PMID: 28362885.
Monteiro A, Lim J, Siddiqi M, Donnelly BM, Khawar W, Baig A, Turner RC, Bouslama M, Raygor KP, Lai PMR, Housley SB, Davies JM, Snyder KV, Siddiqui AH, Levy EI. The first decade of flow diversion for intracranial aneurysms with the Pipeline embolization device. Neurosurg Focus. 2023 May;54(5):E2. doi: 10.3171/2023.2.FOCUS22646. PMID: 37127038.7. Fiehler J, Ortega-Gutierrez S, Anagnostakou V, Cortese J, Cekirge HS, Fiorella D, Hanel R, Kulcsar Z, Lamin S, Liu J, Lylyk P, Marden FA, Pereira VM, Psychogios MN, Rice H, Rouchaud A, Saatci I, Siddiqui AH, Spelle L, Yang P, Grams A, Gounis MJ. Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN. J Neurointerv Surg. 2025 May 22;17(6):632-639. doi: 10.1136/jnis-2023-021404. PMID: 38830670; PMCID: PMC12171491.
Fiehler J, Ortega-Gutierrez S, Anagnostakou V, Cortese J, Cekirge HS, Fiorella D, Hanel R, Kulcsar Z, Lamin S, Liu J, Lylyk P, Marden FA, Pereira VM, Psychogios MN, Rice H, Rouchaud A, Saatci I, Siddiqui AH, Spelle L, Yang P, Grams A, Gounis MJ. Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN. J Neurointerv Surg. 2025 May 22;17(6):632-639. doi: 10.1136/jnis-2023-021404. PMID: 38830670; PMCID: PMC12171491.
Chia GS, de Villiers L, Carraro do Nascimento V, Rapier CL, Owusu MA, Lau FS, McQuinn A, Williams C, Whitley J, Cheung A, Manning NW, Rice H. Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort (SCOPE-AUS). Stroke Vasc Interv Neurol. 2022 Jun 17;2(5):e000292. doi: 10.1161/SVIN.121.000292. PMID: 41584013; PMCID: PMC12778814.
Rice H, Martínez Galdámez M, Holtmannspötter M, Spelle L, Lagios K, Ruggiero M, Vega P, Sonwalkar H, Chapot R, Lamin S. Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study. J Neurointerv Surg. 2020 Nov;12(11):1107-1112. doi: 10.1136/neurintsurg-2020-015943. Epub 2020 Jun 1. PMID: 32482834; PMCID: PMC7569365.
Hanel RA, Cortez GM, Lopes DK, Nelson PK, Siddiqui AH, Jabbour P, Mendes Pereira V, István IS, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer CM, Hellinger FR, Given C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS, Kallmes DF. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15. PMID: 35292570; PMCID: PMC9985759.
D01295063 Rev C

Pipeline™ Flex Embolization Device with Shield Technology™ (ISW)

Indications, Safety, and WarningsCAUTION: 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.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.Contraindications: 1) Patients with active bacterial infection. 2) Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is contraindicated. 3) Patients who have not received dual antiplatelet agents prior to the procedure. 4) Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. 5) Patients in whom the parent vessel size does not fall within the indicated range.
Warnings: 1) Pushing delivery wire without retracting the micro catheter at the same time will cause the open end braid to move distally in the vessel. This may cause damage to the braid or vessel. 2) Use in tortuous anatomy may result in difficulty or inability to deploy the Pipeline™ Flex Embolization Device with Shield Technology™ and can lead to damage to the Pipeline™ Flex Embolization Device with Shield Technology™ and microcatheter. To mitigate potential problems as a result of increased delivery forces, reduce the load in the system by: Unloading the microcatheter to the inner curves of vessel by pulling back on the system (i.e., the microcatheter and delivery wire together). Continue unloading the system until advancement of the device (inside the microcatheter) is observed, while minimizing the distal tip movement to prevent loss of position. Begin to re-advance the delivery wire while maintaining reduced load in the microcatheter. This process should be repeated until the device passes through tortuous area and the delivery force is decreased. 3) Resheathing of the Pipeline™ Flex Embolization Device with Shield Technology™ more than 2 full cycles may cause damage to the distal or proximal ends of the braid. 4) Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Flex Embolization Device with Shield Technology™ implant. 5) Person with known allergy to tin, silver, stainless steel, or silicone elastomer may suffer an allergic reaction to the Pipeline™ Flex Embolization Device with Shield Technology™ delivery system. 6) Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance. 7) Post-procedural movement (migration and/or foreshortening) of the Pipeline™ Flex Embolization Device with Shield Technology™ implant may occur following implantation and can result in serious adverse events and/or death. 8) Factors which may contribute to post procedural device movement include (but are not limited to) the following: Failure to adequately size the implant (i.e., under sizing), Failure to obtain adequate wall apposition during the implant deployment, Implant stretching, Vasospasm, Severe vessel tapering, Tortuous anatomy 9) Delayed rupture may occur with large and giant aneurysms. 10) Placement of multiple Pipeline™ Flex Embolization Device with Shield Technology™ may increase the risk of ischemic complications. 11) Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in difficulty or inability to deploy the Pipeline™ Flex Embolization Device with Shield Technology™ and can lead to damage to the Pipeline™ Flex Embolization Device with Shield Technology™ and microcatheter. Advancement or retraction of the Pipeline™ Flex Embolization Device with Shield Technology™ against resistance may result in damage, including unintended device or component separation, fracture, or breakage of the delivery system due to inherent flexibility limits of device design. Device damage may result in patient injury or death. Refer to page 4 in the instructions for use for additional information. 12) Do not attempt to reposition the device after full deployment. 13) The benefits may not outweigh the risks of treatment of small and medium asymptomatic extradural intracranial aneurysms, including those located in the cavernous internal carotid artery. The risk of rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not negligible. 14) A decrease in the proportion of patients who achieve complete aneurysm occlusion without significant parent artery stenosis has been observed with the use of the device in the communicating segment (C7) of the internal carotid artery (47.4% (9/19 subjects in the PREMIER study at 1 year)), including those IAs fed by the posterior circulation or have retrograde filling. Ensure appropriate patient selection and weigh the benefits and risks of alternative treatments prior to use of this device for the treatment of intracranial aneurysms located in this region of the ICA. The following anatomical characteristics, associated with retrograde filling, should be carefully considered during procedural planning of C7 intracranial aneurysms: PComm of fetal origin (A PCA of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA); PComm overlapping with the aneurysm neck; and/or PComm branch arising from the dome of the aneurysm. 15) The safety and effectiveness of this device for radial neurovasculature access in direct comparison to a transfemoral approach has not been demonstrated. The risks and benefits for radial access against a transfemoral approach should be carefully weighed and considered for each patient.Precautions: 1) The Pipeline™ Flex Embolization Device with Shield Technology™ should be used only by physicians trained in percutaneous, intravascular techniques, and procedures at medical facilities with the appropriate fluoroscopy equipment. 2) Physicians should undergo appropriate training prior to using the Pipeline™ Flex Embolization Device with Shield Technology™ in patients. 3) The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for single use only. Store in a cool, dry place. Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. Do not use kinked or damaged components. Do not use product if the sterile package is damaged. 4) Use the Pipeline™ Flex Embolization Device with Shield Technology™ system prior to the “Use By” date printed on the package. 5) The appropriate anti-platelet and anti- coagulation therapy should be administered in accordance with standard medical practice. 6) A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy. 7) Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated. 8) The Pipeline™ Flex Embolization Device with Shield Technology™ may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment. 9) Take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible. 10) Carefully weigh the benefits of treatment vs. the risks associated with treatment using the device for each individual patient based on their medical health status and risks factors for intracranial aneurysm rupture during their expected life time such as age, medical comorbidities, history of smoking, intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging, presence of multiple intracranial aneurysms, and presence of concurrent pathology. The benefits of device use may not outweigh the risks associated with the device in certain patients; therefore, judicious patient selection is recommended. 11) The safety and effectiveness of the device has not been established for treatment of fusiform IAs. 12) There may be a decrease in effectiveness and increase in safety events when the device is used in patients ≥ 60 years old. 13) The safety and effectiveness of the device has not been evaluated or demonstrated for ruptured aneurysms. 14) If using radial artery access, perform a screening examination of the radial artery per institutional practices to ensure that radial access is appropriate for the patient.Potential Complications: Potential complications of the device and the endovascular procedure include, but are not limited to, the following: Access site complications like hematoma, inflammation, infection, necrosis, pain and tenderness, granuloma; Adverse reaction to anti-platelet/anticoagulation agents, anesthesia, reactions due to radiation exposure (such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts and delayed neoplasia) or contrast media, including organ failure; Vascular Complications like vasospasm, stenosis, dissection, perforation, rupture, fistula formation, pseudo aneurysm, occlusion, thromboembolic complications including ischemia (to unintended territory); Device complications like fracture, breakage (including unintended device or component separation), misplacement, migration/delayed foreshortening or reaction to device materials may occur; Systemic Complications like: Infection, Pain, fever, allergic reactions, organ failure, nerve damage; Bleeding/hemorrhagic complication including retroperitoneal hemorrhage; Neurological Deficits or dysfunctions including Stroke, Infarction, Loss of vision, Seizures, TIA, Headache, Cranial Nerve Palsies, Confusion, Coma, Hand Dysfunction; Decreased therapeutic response including need for target aneurysm retreatment; Risks associated with visual symptoms include Amaurosis Fugax/transient blindness, Blindness, Diplopia, Reduced visual acuity/field, Retinal artery occlusion, Retinal ischemia, Retinal infarction, Vision impairment including scintillations, blurred vision, eye floaters; Intra-Cranial Hemorrhage (including from Aneurysm Rupture) Brain Edema, Hydrocephalus, Mass Effect; DeathComplete indications, Contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.US-NEU-2400022

Pipeline™ Vantage Embolization Device with Shield Technology™ (ISW)

Indications, Safety, and WarningsIndications for useCaution:
Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.This device should be used only by physicians with a thorough understanding of angiography and/or percutaneous neurointerventional procedures.Indications For Use (US):The Pipeline™ Vantage 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™ Vantage 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.Contraindications:
1) Patients with active bacterial infection. 2) Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is contraindicated. 3) Patients who have not received antiplatelet agents prior to the procedure. 4) Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. 5) Patients in whom the parent vessel size does not fall within the indicated range.Warnings:1) Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Vantage Embolization Device with Shield Technology™ implant. 2) Person with known allergy to platinum alloy (including major elements platinum, tungsten, iridium), tin, silver, stainless steel or silicone elastomer may suffer an allergic reaction to the Pipeline™ Vantage Embolization Device with Shield Technology™ delivery system. 3) Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance. 4) Post-procedural movement (migration and/or foreshortening) of the Pipeline™ Vantage Embolization Device with Shield Technology™ implant may occur following implantation and can result in serious adverse events and/or death. 5) Factors which may contribute to post procedural device movement include (but are not limited to) the following: Failure to adequately size the implant (i.e., under sizing), failure to obtain adequate wall apposition during the implant deployment, implant stretching, vasospasm, severe vessel tapering, tortuous anatomy. 6) Delayed rupture may occur with large and giant aneurysms. 7) Placement of multiple Pipeline™ Vantage Embolization Device with Shield Technology™ may increase the risk of ischemic complications. 8) Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in difficulty or inability to deploy the Pipeline™ Vantage Embolization Device with Shield Technology™ and can lead to damage to the Pipeline™ Vantage Embolization Device with Shield Technology™ and microcatheter. Advancement or retraction of the Pipeline™ Vantage Embolization Device with Shield Technology™ against resistance may result in damage, including unintended device or component, separation, fracture, or breakage of the deliver system due to inherent flexibility limits of device design. Device damage may result in patient injury or death. Refer to page 4 in the instructions for use for additional information. 9) Do not attempt to reposition the device after full deployment. 10) The benefits may not outweigh the risks of treatment of small and medium asymptomatic extradural intracranial aneurysms, including those located in the cavernous internal carotid artery. The risk of rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not negligible. 11) A decrease in the proportion of patients who achieve complete aneurysm occlusion without significant parent artery stenosis has been observed with the use of the device in the communicating segment (C7) of the internal carotid artery (47.4% (9/19 subjects in the PREMIER study at 1 year)), including those IAs fed by the posterior circulation or have retrograde filling. Ensure appropriate patient selection and weigh the benefits and risks of alternative treatments prior to use of this device for the treatment of intracranial aneurysms located in this region of the ICA. The following anatomical characteristics, associated with retrograde filling, should be carefully considered during procedural planning of C7 intracranial aneurysms: 1. PComm of fetal origin (A PCA of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA); 2. PComm overlapping with the aneurysm neck; and/or 3. PComm branch arising from the dome of the aneurysm. 12) Pipeline™ Vantage Embolization Device with Shield Technology™ has not been tested for radial artery access. Radial artery access should only be used when femoral artery access is not feasible. 13)For additional Materials of Concerns information such as CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship.Precautions:1) The Pipeline™ Vantage Embolization Device with Shield Technology™ should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopic equipment. 2) Physicians should undergo appropriate training prior to using the Pipeline™ Vantage Embolization Device with Shield Technology™ in patients. 3) The Pipeline™ Vantage Embolization Device with Shield Technology™ is intended for single use only. Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. 4) Do not use kinked or damaged components. 5) Do not use product if the sterile package is damaged. 6) Use the Pipeline™ Vantage Embolization Device with Shield Technology™ system prior to the “Use-by date” printed on the package. 7) The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. 8) A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy. 9) Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated. 10)The Pipeline™ Vantage Embolization Device with Shield Technology™ may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment. 11) Take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible. 12) Carefully weigh the benefits of treatment vs. the risks associated with treatment using the device for each individual patient based on their medical health status and risks factors for intracranial aneurysm rupture during their expected life time such as age, medical comorbidities, history of smoking, intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging, presence of multiple intracranial aneurysms, and presence of concurrent pathology.The benefits of device use may not outweigh the risks associated with the device in certain patients; therefore, judicious patient selection is recommended. 13) The safety and effectiveness of the device has not been established for treatment of fusiform IAs. 14)There may be a decrease in effectiveness and increase in safety events when the device is used in patients ≥ 60 years old. 15) The safety and effectiveness of the device has not been evaluated or demonstrated for ruptured aneurysms.Potential Complications:Potential complications of the device and the endovascular procedure include or are synonymous with, but may not be limited to the following:Access site complications such as hematoma, pain, retroperitoneal hemorrhage, skin discoloration, nerve damage, abscess, edema; Adverse reactions to antiplatelet/anticoagulation agents, contrast media, or anesthesia such as pain, hemorrhage, organ failure, aspiration, nausea; Cardiac complications such as arrhythmia, myocardial infarction; Compartmental complications such as brain edema, intracranial hypertension, mass effect, hydrocephalus; Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia; Device complications such as kink, stretching, device fracture, device migration, device misplacement, friction, foreign body in patient, premature deployment, inadequate deployment, premature detachment, non-detachment; Hematologic complications such as coagulopathy, thrombosis, hemolysis, intracranial hemorrhage; Neurological deficits or dysfunctions such as headache, seizures, coma, emotional changes, paresis, transient ischemic attack, stroke; Systemic complications such as fever, infection, inflammation, edema, shock, toxicity, hypersensitivity, allergic reaction, organ failure, hypotension, hypertension, pain; Decreased therapeutic response including need for target aneurysm treatment; Vascular complications such as dissection, perforation, rupture, ischemia, vasospasm, stenosis, necrosis, granuloma, fistula, pseudoaneurysm, occlusion, thromboembolism, embolism including to unintended territory; Visual complications such as transient blindness, blindness, diplopia, reduced visual acuity/field, retinal artery occlusion, retinal ischemia, retinal infarction, scintillations, blurred vision, eye floaters; Death.*Consult instructions for use for other therapy devices and medications for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.US-NNP-2400080 (v1.0)

>100K

>58K

>1K

Pioneers of flow diversion

Healthcare professional

Engineer