Shield Technology™

Shield Technology™
NVTV

What is Shield Technology™?

Enables smoother delivery and resheathing^6,**Data is derived from the referenced studies and may not be representative of clinical performance.
Reduces material thrombogenicity
Due to a proprietary surface modification, Pipeline™ Embolization Device with Shield Technology™ Family* implants demonstrate a reduction in thrombus formation compared to a bare flow diverter in acute benchtop in-vitro testing.^2**
**Data derived from acute benchtop in-vitro testing may not be representative of clinical performance.

What makes Shield Technology™ different?

Unlike traditional flow diverters with surface coatings, Shield Technology™ is a surface modification adhered to the implant by covalently bonding through a chemical reaction.^{1, 8}The thickness of Shield Technology™ is less than ~3 nanometers (0.01% of one braid wire).¹⁷

Shield Technology™ is Backed by Science

Shield Technology™ was assessed in several preclinical models, including:

Thrombogram Analysis
Human Blood Loop Model
Ex Vivo Primate Shunt Model
Rabbit Elastase Aneurysm Model
Neointima Procine Model
Bench Testing

See the data (open in new window)

Shield Technology™

Shield Technology™ creates a thin boundary layer that is hydrophilic, reducing contact friction in the presence of water, saline or blood. Due to Shield Technology that integrates synthetic phosphorylcholine (PC) to the surface of the braid, the implant has reduced delivery forces (20% reduction) and resheathing forces (12% reduction) when compared to unmodified Pipeline Flex implants based on benchtop tests².

** Data is derived from referenced bench testing and may not be representative of clinical performance.

Pipeline™ Flex with
Shield Technology™

The clinically proven¹¹ 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.^12,13 Learn about the engineering behind our Flow Diverters.

Learn More

References:

Medtronic Internal Study, D00422708 Rev. A, Competitive Test Report - Material Thrombogenicity Evaluation of Flow Diversion Devices.
TR-NV11011 Rev. C, Surface treated Pipeline depth profile characterization
Girdhar G, Li J, Kostousov L, Wainwright J, Chandler WL. In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices. J Thromb Thrombolysis. 2015 Nov;40(4):437-43. doi: 10.1007/s11239-015-1228-0. PMID: 25975924.
Matsuda Y, Chung J, Lopes DK. Analysis of neointima development in flow diverters using optical coherence tomography imaging. J Neurointerv Surg. 2018 Feb;10(2):162-167. doi: 10.1136/neurintsurg-2016-012969. Epub 2017 Jun 7. PMID: 28592484; PMCID: PMC5800337.
Caroff J, Tamura T, King RM, Lylyk PN, Langan ET, Brooks OW, Clarençon F, Wainwright JM, Spelle L, Marosfoi M, Gounis MJ, Puri AS. Phosphorylcholine surface modified flow diverter associated with reduced intimal hyperplasia. J Neurointerv Surg. 2018 Nov;10(11):1097-1101. doi: 10.1136/neurintsurg-2018-013776. Epub 2018 Mar 6. PMID: 29511117.
Medtronic Internal Study, TR-NV11991 Rev. B, Performance Evaluation of the Pipeline Flex Embolization Device with Shield Technology
Platelet Activation and Factors for Clot Formation https://youtu.be/R8JMfbYW2p4?si=05Oi7V1F1PVLnzSH
Girdhar G, Li J, Kostousov L, Wainwright J, Chandler WL. In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices. J Thromb Thrombolysis. 2015 Nov;40(4):437-43. doi: 10.1007/s11239-015-1228-0. PMID: 25975924.
Gaurav Girdhar, Samantha Ubl, Reza Jahanbekam, Sinduja Thinamany, Anna Belu, John Wainwright, Michael F. Wolf, Thrombogenicity assessment of Pipeline, Pipeline Shield, Derivo and P64 flow diverters in an in vitro pulsatile flow human blood loop model,eNeurologicalSci,Volume 14,2019,Pages 77-84,ISSN 2405-6502,https://doi.org/10.1016/j.ensci.2019.01.004.
PEDESTRIAN - Lylyk I, Scrivano E, Lundquist J, Ferrario A, Bleise C, Perez N, Lylyk PN, Viso R, Nella-Castro R, Lylyk P. Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms, Single-Center Registry: Long-Term Angiographic and Clinical Outcomes from 1000 Aneurysms. Neurosurgery. 2021 Aug 16;89(3):443-449. doi: 10.1093/neuros/nyab183. PMID: 34098575; PMCID: PMC8374967.
Medtronic Internal Report FD3456 Rev B, PUFS 5 Year CSR
Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15. PMID: 23418004.
Kallmes, DF et al. International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study, AJNR Published online, Oct 29, 2014
Platelet Activation and Factors for Clot Formation https://youtu.be/R8JMfbYW2p4?si=05Oi7V1F1PVLnzSH
Gaurav Girdhar, Samantha Ubl, Reza Jahanbekam, Sinduja Thinamany, Anna Belu, John Wainwright, Michael F. Wolf,Thrombogenicity assessment of Pipeline, Pipeline Shield, Derivo and P64 flow diverters in an in vitro pulsatile flow human blood loop model,eNeurologicalSci,Volume 14,2019,Pages 77-84,ISSN 2405-6502,https://doi.org/10.1016/j.ensci.2019.01.004.
Girdhar G, Li J, Kostousov L, Wainwright J, Chandler WL. In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices. J Thromb Thrombolysis. 2015 Nov;40(4):437-43. doi: 10.1007/s11239-015-1228-0. PMID: 25975924.
Rice H, de Villiers L, Owusu M, et al. Five-year australian experience with pipeline™ flex embolization devices with shield technology™: real world evidence (SCOPE-AUS). Journal of NeuroInterventional Surgery 2019;11:A7.

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 WarningsCaution:
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:

Patients with active bacterial infection.

Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is contraindicated.

Patients who have not received antiplatelet agents prior to the procedure.

Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.

Patients in whom the parent vessel size does not fall within the indicated range.

Warnings:

Pre-deploying the distal end of the device prior to introduction into the micro catheter may cause damage to the distal end of the braid.

Pushing delivery wire without retracting the micro catheter at the same time will cause the open-end of the braid to move distally in the vessel. This may cause damage to the braid or vessel.

Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in difficulty or inability to deploy the Pipeline™ Vantage device and can lead to damage to the Pipeline™ Vantage device and micro catheter. To mitigate potential problems as a result of increased delivery forces, reduce the load in the system by:

Unloading the micro catheter to the inner curves of vessel by pulling back on the system (i.e., the micro catheter and delivery wire together).
Continue unloading the system until advancement of the device (inside of micro catheter) 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 micro catheter. This process should be repeated until the device passes through tortuous area and the delivery force is decreased.

Following distal deployment and device anchoring:

Avoid stretching and/or creating tension in the implant before unsheathing the proximal end.
Avoid deploying the implant if kinking or twisting is observed. Fully deploying the device under the conditions above may lead to poor wall apposition, unanticipated device foreshortening, device migration, thromboembolic risk, and impaired aneurysm occlusion. Device kinking, twisting, or stretching may be resolved with appropriate positioning of the micro catheter or by resheathing the entire implant and repeating distal deployment, adjusting the technique combination of unsheathing the implant and pushing the delivery wire. If it cannot be resolved, consider replacing the device.

Avoid deploying the implant if kinking or twisting is observed.

Incomplete wall apposition can result in unanticipated device foreshortening, device migration, and/ or device deformation which can lead to thromboembolic risks, elevated neointimal hyperplasia formation and/or reduced intracranial aneurysm occlusion.

Resheathing the Pipeline™ Vantage device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.

Resheathing the Pipeline™ Vantage device past the distal marker of the delivery system may cause damage to the distal end of the braid.

Malapposition to the vessel wall at the proximal end of the implant may lead to stenosis, stroke or death.

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.

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.

Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance

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.

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

Delayed rupture may occur with large and giant aneurysms.

Placement of multiple Pipeline™ Vantage Embolization Device with Shield Technology™ may increase the risk of ischemic complications

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 micro catheter. 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 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.

Do not attempt to reposition the device after full deployment.

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.

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.

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.

For additional Materials of Concerns information such as CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship

Precautions:

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.

Physicians should undergo appropriate training prior to using the Pipeline™ Vantage Embolization Device with Shield Technology™ in patients.

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.

Do not use kinked or damaged components.

Do not use product if the sterile package is damaged.

Use the Pipeline™ Vantage Embolization Device with Shield Technology™ system prior to the “Use-by date” printed on the package.

The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.

A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy.

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.

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.

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.

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.

In the INSPIRE-A registry, there was an observation of increased braid deformity in female patients, especially in female patients less than 45 years of age

The safety and effectiveness of the device has not been established for treatment of fusiform IAs.

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, braid deformation; Braid deformation is a potential complication with all flow diverters and may occur during or following the index procedure and has been observed to occur months after implantation;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, hyperplasia, 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-2300015 (v3.0)

What is Shield Technology™?

What makes Shield Technology™ different?

Unlike traditional flow diverters with surface coatings, Shield Technology™ is a surface modification adhered to the implant by covalently bonding through a chemical reaction.^{1, 8}The thickness of Shield Technology™ is less than ~3 nanometers (0.01% of one braid wire).¹⁷

Shield Technology™ is Backed by Science

Pipeline™ Flex with
Shield Technology™

United States

Customer Care Team

Shield Technology™

What is Shield Technology™?

What makes Shield Technology™ different?

Unlike traditional flow diverters with surface coatings, Shield Technology™ is a surface modification adhered to the implant by covalently bonding through a chemical reaction.1, 8 The thickness of Shield Technology™ is less than ~3 nanometers (0.01% of one braid wire).17

Shield Technology™ is Backed by Science

Pipeline™ Flex with Shield Technology™

United States

Customer Care Team

Unlike traditional flow diverters with surface coatings, Shield Technology™ is a surface modification adhered to the implant by covalently bonding through a chemical reaction.^{1, 8}The thickness of Shield Technology™ is less than ~3 nanometers (0.01% of one braid wire).¹⁷

Pipeline™ Flex with
Shield Technology™