{"id":771,"date":"2022-04-19T09:27:53","date_gmt":"2022-04-19T16:27:53","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=771"},"modified":"2026-01-12T15:07:30","modified_gmt":"2026-01-12T23:07:30","slug":"indicationssafetywarnings","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/indicationssafetywarnings\/","title":{"rendered":"Indications, Safety & Warnings"},"content":{"rendered":"

[vc_row min_height=”550px” content_placement=”middle” custom_bg_type=”image” custom_bg_cover=”cover” custom_bg_repeat=”no-repeat” custom_bg_position=”Center center” nav_skin=”light” consent_include=”include” equal_height=”true” el_design=”{“desktop“:{“padding-top“:“200“,“padding-bottom“:“100“}}” custom_bg_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” custom_bg_image=”676″][vc_column css_animation=””][vc_heading heading_text=”Indications, Safety & Warnings” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” heading_typography=”{“font_family“:“240743169“,“font_size“:“60px“,“line_height“:“1.2em“,“letter_spacing“:“-0.03em“}” responsiveness=”yes” tablet_portrait=”90″ mobile_landscape=”80″ mobile_portrait=”70″ css_animation=””][\/vc_column][\/vc_row][vc_section nav_skin=”light”][vc_row nav_skin=”light” consent_include=”include”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“40“,“padding-left“:“15“}}” css_animation=””][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]<\/p>\n

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INDICATIONS:<\/h2>\n

IMPEDE\u00ae<\/sup> Embolization Plug<\/h4>\n

The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.<\/p>\n

IMPEDE-FX Embolization Plug (US)<\/h4>\n

In the United States, the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.<\/p>\n

IMPEDE-FX Embolization Plug (OUS)<\/h4>\n

INTENDED PURPOSE: In countries recognizing CE marking, the IMPEDE-FX Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.<\/p>\n

IMPEDE-FX RapidFill\u00ae<\/sup> (OUS)<\/h4>\n

INTENDED PURPOSE: In countries recognizing CE marking, the IMPEDE-FX RapidFill is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.<\/p>\n

IMPEDE-FX RapidFill is not available for sale in the U.S.<\/p>\n

TrelliX\u00ae<\/sup> Embolic Coil (OUS)<\/h4>\n

In countries recognizing CE marking, the TrelliX Embolic Coil System is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Indications include: intracranial aneurysms; other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae; arterial and venous embolizations in the peripheral vasculature.<\/p>\n

The TrelliX Embolic Coil is not available for sale in the U.S.<\/p>\n

TrelliX\u00ae<\/sup> Detachment Controller (OUS)<\/h4>\n

In countries recognizing CE marking, the TrelliX Detachment Controller is intended for use with the TrelliX Embolic Coil System which is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Indications include: Intracranial aneurysms; Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae; arterial and venous embolizations in the peripheral vasculature<\/p>\n

The TrelliX Detachment Controller is not available for sale in the U.S.<\/p>\n<\/div>\n<\/div>\n

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WARNINGS:<\/h2>\n

IMPEDE\u00ae<\/sup> Embolization Plug<\/h4>\n

The safety and effectiveness of the IMPEDE Embolization Plug has not been established for cardiac uses (e.g., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closure) or neurologic uses.<\/p>\n

\u2022 Inspect the package and system prior to use. Do not use if the sterile package is open or damaged or if the system is damaged.<\/p>\n

\u2022 Device is intended for single use only. Do not attempt to re-process, re-sterilize, clean, or reuse the device. Improper sterilization and reuse can cause malfunction to the device and injury to the patient.<\/p>\n

\u2022 Do not use a power injection syringe to inject contrast solution through the device.<\/p>\n

\u2022 Do not use after the \u201cUse-by\u201d date specified on the package.<\/p>\n

\u2022 Only physicians who have received appropriate training and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with embolization and interventional procedures should use this device.<\/p>\n

\u2022 Please note care in specific populations: pregnancy – care should be taken to minimize radiation exposure to the mother and fetus, and nursing mothers – there has been no quantitative assessment of the presence of leachables in breast milk.<\/p>\n

IMPEDE-FX Embolization Plug<\/h4>\n

The safety and effectiveness of the IMPEDE-FX Embolization Plug has not been established for cardiac uses (e.g., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closure) or neurologic uses.<\/p>\n

\u2022 Inspect the package and system prior to use. Do not use if the sterile package is open or damaged or if the system is damaged.<\/p>\n

\u2022 Device is intended for single use only. Do not attempt to re-process, re-sterilize, clean, or reuse the device. Improper sterilization and reuse can cause malfunction to the device and injury to the patient.<\/p>\n

\u2022 Do not use a power injection syringe to inject contrast solution through the device.<\/p>\n

\u2022 Do not use after the \u201cUse-by\u201d date specified on the package.<\/p>\n

\u2022 Only physicians who have received appropriate training and who are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with embolization and interventional procedures should use this device.<\/p>\n

\u2022 Please note care in specific populations: pregnancy – care should be taken to minimize radiation exposure to the mother and fetus, and nursing mothers – there has been no quantitative assessment of the presence of leachables in breast milk.<\/p>\n

IMPEDE-FX RapidFill\u00ae<\/sup><\/h4>\n

The safety and effectiveness of the IMPEDE-FX Rapid Fill has not been established for cardiac uses (e.g., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closure) or neurologic uses.<\/p>\n

\u2022 Inspect the package and system prior to use. Do not use if the sterile package is open or damaged or if the system is damaged.<\/p>\n

\u2022 Device is intended for single use only. Do not attempt to re-process, re-sterilize, clean, or reuse the device. Improper sterilization and reuse can cause malfunction to the device and injury to the patient.<\/p>\n

\u2022 Do not use a power injection syringe to inject contrast solution through the device.<\/p>\n

\u2022 Do not use after the \u201cUse-by\u201d date specified on the package.<\/p>\n

\u2022 Only physicians who have received appropriate training and who are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with embolization and interventional procedures should use this device.<\/p>\n

\u2022 Please note care in specific populations: pregnancy – care should be taken to minimize radiation exposure to the mother and fetus, and nursing mothers – there has been no quantitative assessment of the presence of leachables in breast milk.<\/p>\n

TrelliX\u00ae<\/sup> Embolic Coil<\/h4>\n

The TrelliX Embolic Coil System is compatible with the TrelliX Detachment Controller. DO NOT SUBSTITUTE any components or devices with components or devices from other manufacturers. Substitution could result in injury to patient and\/or user.<\/p>\n

\u2022 DO NOT use if the sterile package is open or damaged or if the system is damaged.<\/p>\n

\u2022 DO NOT use after the \u201cUse-by\u201d date specified on the package.<\/p>\n

\u2022 DO NOT attempt to re-sterilize or otherwise re-use.<\/p>\n

\u2022 DO NOT advance the delivery pusher with excessive force.<\/p>\n

\u2022 To reduce the risk of coil migration, the diameter of the first and second coil should never be less than the width of the ostium.<\/p>\n

\u2022 Advancing the delivery pusher beyond the microcatheter tip once the coil has been detached involves risk of aneurysm or vessel perforation.<\/p>\n

\u2022 DO NOT rotate the delivery pusher during or after delivery of the coil. Rotating the delivery pusher may result in a stretched or premature detachment of the coil from the delivery pusher, which could result in coil migration.<\/p>\n

\u2022 Damaged delivery pushers may cause vessel injury or unpredictable distal tip response during coil deployment.<\/p>\n

\u2022 The fluoro-saver marker is designed for use with a rotating hemostatic valve (RHV). If used without an RHV, the distal end of the coil may be beyond the alignment marker when the fluoro-saver marker reaches the microcatheter hub.<\/p>\n

\u2022 DO NOT overtighten the RHV around the introducer sheath. Excessive tightening may cause damage to the device.<\/p>\n

\u2022 The fluoro-saver marker is designed for use with a microcatheter length of 150cm or greater. If used with a microcatheter shorter than 150cm, the distal end of the coil may be beyond the alignment marker when the fluoro-saver marker reaches the microcatheter hub.<\/p>\n

\u2022 Microcatheter tip movement could cause the aneurysm or vessel to rupture.<\/p>\n

\u2022 DO NOT place the TrelliX delivery pusher on a bare metallic surface.<\/p>\n

\u2022 If implant fails to detach, to minimize disturbance to the coil placement and delivery pusher, only press the \u201cDetach Button\u201d again to reinitiate. DO NOT remove or modify delivery pusher position.<\/p>\n

TrelliX\u00ae<\/sup> Detachment Controller<\/strong><\/h4>\n

This device should only be used by physicians trained in interventional neuroradiology or interventional radiology on the use of this device as established by Shape Memory Medical Inc. The TrelliX Detachment Controller can only be used with the TrelliX Embolic Coil System. Use of the TrelliX Detachment Controller with another manufacturer\u2019s device may lead to injury to the patient or user.<\/p>\n

\u2022 DO NOT attempt to use the TrelliX Detachment Controller with another manufacturer\u2019s devices due to potential incompatibility. Safety and performance have NOT been established with another manufacturer\u2019s devices and is not recommended.<\/p>\n

\u2022 Inspect the package and system prior to use. DO NOT use if the sterile package is open or damaged or if the system is damaged.<\/p>\n

\u2022 The TrelliX Detachment Controller is intended for SINGLE PATIENT USE ONLY. DO NOT attempt to re-process, re-sterilize, clean, or re-use the device. Improper sterilization and re-use can cause malfunction of the device and injury to the patient.<\/p>\n

\u2022 DO NOT use after the “Use-by” date specified on the package.<\/p>\n

\u2022 DO NOT use if labeling is incomplete or illegible.<\/p>\n

\u2022 The TrelliX Detachment Controller should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the TrelliX Detachment Controller should be observed to verify normal operation in the configuration in which it will be used.<\/p>\n

\u2022 There are no cables, transducers or other accessories that are likely to affect compliance of this equipment with the appropriate electro-magnetic standards.<\/p>\n

\u2022 When handling the controller during device operation, always use double-gloved hands in order to provide necessary insulation from any malfunctions that may cause heat generation.<\/p>\n

\u2022 Advancing the TrelliX Detachment Controller onto the TrelliX delivery pusher with excessive force may cause a kink in the delivery pusher or displacement of the coil from the target site, which could lead to failed detachment, suboptimal coil position, vessel\/aneurysm perforation, or damage to the TrelliX Detachment Controller.<\/p>\n

\u2022 DO NOT advance the delivery pusher once the coil has been detached as it may increase risk of aneurysm or vessel perforation.<\/p>\n

\u2022 After use, the TrelliX Detachment Controller and its packaging should be handled as biohazardous waste and disposed of properly, in compliance with hospital, local, and governmental laws and policies.<\/p>\n

\u2022 No modification of the device is allowed.<\/p>\n<\/div>\n<\/div>\n

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PRECAUTIONS:<\/h2>\n

IMPEDE\u00ae<\/sup> Embolization Plug<\/h4>\n

The IMPEDE Embolization Plug consists of a nickel-titanium alloy that is generally considered safe. Patients who are allergic to nickel may have an allergic reaction, especially those with a history of metal allergies.<\/p>\n

\u2022 Physicians should exercise clinical judgment in situations that involve use of anticoagulants or antiplatelet drugs before, during, and\/or after use of the device.<\/p>\n

\u2022 Verify IMPEDE Embolization Plug compatibility when using other ancillary devices in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.<\/p>\n

\u2022 It is recommended to deploy the IMPEDE Embolization Plug to the target vessel within one (1) minute of entering the catheter\/sheath (i.e. working time). A working time greater than one (1) minute (i.e. exposure within an aqueous environment) may result in increased delivery friction or the device may not be able to exit the catheter into the target vessel.<\/p>\n

\u2022 Excessive use of contrast solution injections immediately following deployment to target vessel and prior to full expansion of the SMP plug may inhibit full expansion and performance of IMPEDE Embolization Plug.<\/p>\n

\u2022 Verify temperature indicator label on front of pouch has not exceeded 40\u00b0C (105\u00b0F). If temperature indicator label shows temperature has been exceeded (indicator dot color is black), do not use device as SMP Plug may have expanded impacting delivery performance.<\/p>\n

\u2022 It is not recommended to wet the IMPEDE Embolization Plug prior to use. Exposure to an aqueous environment will impact the device working time.<\/p>\n

\u2022 If difficulties occur when deploying the IMPEDE Embolization Plug and the SMP Plug has not exited the catheter\/sheath within the recommended working time, wait a minimum of five (5) minutes to allow the SMP Plug to expand within the catheter\/sheath. Withdraw and remove the guidewire; using a syringe to apply light suction, remove the device and catheter\/sheath simultaneously as one unit.<\/p>\n

\u2022 Physicians should verify catheter\/sheath compatibility with guidewire and IMPEDE prior to use. Refer to Table 1 and Table 2 for device and accessory selection guidance.<\/p>\n

\u2022 Refer to product label for device dimensions to determine vessel diameter compatibility. 2.0cm \u2013 4.5cm of landing zone is recommended and physician discretion should be used during device selection.<\/p>\n

IMPEDE-FX Embolization Plug<\/h4>\n

Physicians should exercise clinical judgement in situations that involve use of anticoagulants or antiplatelet drugs before, during, and\/or after use of the device.<\/p>\n

\u2022 Physicians should exercise clinical judgement when using the IMPEDE-FX Embolization Plug in anatomy that may lead to unintended device placement and\/or movement (i.e. high flow vasculature, large luminal vessel diameter).<\/p>\n

\u2022 The IMPEDE-FX Embolization Plug is intended to self-expand in vivo. Placement in vessels too small to accept the selected device may cause injury.<\/p>\n

\u2022 Verify IMPEDE-FX Embolization Plug compatibility when using other ancillary devices in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.<\/p>\n

\u2022 It is recommended to deploy the IMPEDE-FX Embolization Plug to the target vessel within one (1) minute of entering the catheter\/sheath (working time). A working time greater than one (1) minute (i.e. exposure within an aqueous environment) may result in increased delivery friction or the device may not be able to exit the catheter into the target vessel.<\/p>\n

\u2022 Excessive use of contrast solution injections immediately following deployment to target vessel and prior to full expansion of IMPEDE-FX Embolization Plug may inhibit full expansion and performance of IMPEDE-FX Embolization Plug.<\/p>\n

\u2022 Verify temperature indicator label on front of pouch has not exceeded 40\u00b0C (105\u00b0F). If temperature indicator label shows temperature has been exceeded, do not use device as SMP Plug may have expanded impacting delivery performance.<\/p>\n

\u2022 It is not recommended to wet the IMPEDE-FX Embolization Plug prior to use. Exposure to an aqueous environment will impact the device working time.<\/p>\n

\u2022 If difficulties occur when deploying the IMPEDE-FX Embolization Plug and the SMP Plug has not exited the catheter\/sheath within the recommended working time, wait a minimum of five (5) minutes to allow the SMP Plug to expand within the catheter\/sheath. Withdraw and remove the guidewire; using a syringe to apply light suction, remove the device and catheter\/sheath simultaneously as one unit.<\/p>\n

\u2022 Catheter\/sheath and guidewire selection, by the physician, must be selected to minimize gaps that may allow the guidewire tip to inadvertently wedge between the device and catheter lumen. Refer to Table 1 and Table 2 for device and accessory selection guidance.<\/p>\n

\u2022 Refer to product label for device dimensions to determine vessel diameter compatibility.<\/p>\n

IMPEDE-FX RapidFill\u00ae<\/sup><\/h4>\n

Physicians should exercise clinical judgement in situations that involve use of anticoagulants or antiplatelet drugs before, during, and\/or after use of the device.<\/p>\n

\u2022 Physicians should exercise clinical judgement when using the IMPEDE-FX Rapid Fill in anatomy that may lead to unintended device placement and\/or movement (i.e. high flow vasculature, large luminal vessel diameter).<\/p>\n

\u2022 The IMPEDE-FX Rapid Fill plug is intended to self-expand in-vivo. Placement in vessels too small in diameter and\/or total volume to accept the selected device may cause injury.<\/p>\n

\u2022 Verify IMPEDE-FX Rapid Fill compatibility when using other ancillary devices in intravascular procedures. Physician must be familiar with percutaneous, intravascular techniques and possible complications associated with the procedure.<\/p>\n

\u2022 It is recommended to deploy the IMPEDE-FX Rapid Fill to the target vessel within one (1) minute of entering the catheter\/sheath (working time). A working time greater than one (1) minute (i.e. exposure within an aqueous environment) may result in increased delivery friction or the device may not be able to exit the catheter into the target vessel.<\/p>\n

\u2022 Due to the low delivery resistance of the crimped SMP Plug, it is recommended to use fluoroscopic visualization to verify the presence of the SMP Plug and its platinum markerband prior to exiting the catheter\/sheath to avoid misdeployment and\/or unintended migration.<\/p>\n

\u2022 Excessive use of contrast solution injections immediately following deployment to target vessel and prior to full expansion of the IMPEDE-FX Rapid Fill plug may inhibit full expansion and performance of the IMPEDE-FX Rapid Fill plug.<\/p>\n

\u2022 Verify temperature indicator label on front of pouch has not exceeded 40\u00b0C (105\u00b0F). If temperature indicator label turns black, temperature has been exceeded. Do not use device as SMP Plug may have expanded impacting delivery performance.<\/p>\n

\u2022 It is not recommended to wet the IMPEDE-FX Rapid Fill prior to use. Exposure to an aqueous environment will impact the device working time.<\/p>\n

\u2022 If difficulties occur when deploying the IMPEDE-FX Rapid Fill and the SMP Plug has not exited the catheter\/sheath within the recommended working time, wait a minimum of five (5) minutes to allow the SMP Plug to expand within the catheter\/sheath. Withdraw and remove the guidewire; using a syringe to apply light suction, remove the device and catheter\/sheath simultaneously as one unit.<\/p>\n

\u2022 Catheter\/sheath and guidewire selection, by the physician, must be selected to minimize gaps that may allow the guidewire tip to inadvertently wedge between the device and catheter lumen. Refer to Table 1 and Table 2 for device and accessory selection guidance.<\/p>\n

\u2022 Refer to product label for device dimensions to determine vessel diameter compatibility.<\/p>\n

TrelliX\u00ae<\/sup> Embolic Coil<\/h4>\n

High quality, digital subtraction fluoroscopic road mapping is MANDATORY to achieve safe placement of the TrelliX Embolic Coil System.<\/p>\n

\u2022 Take all necessary precautions to limit fluoroscopic radiation doses to patients and clinical operators by using sufficient shielding, reducing fluoroscopy times, and modifying x-ray technical factors whenever possible.<\/p>\n

\u2022 It is recommended to deploy the TrelliX Embolic Coil System to the target site within ten (10) minutes of entering the microcatheter (working time). A working time greater than ten (10) minutes (i.e. exposure within an aqueous environment) may result in increased delivery friction or the device may not be able to retract into the microcatheter without risk to damage to the device.<\/p>\n

\u2022 The TrelliX 18 embolic coil includes an outer layer of shape memory polymer (SMP). The primary coil diameter will slowly increase to a maximum 0.030\u201d (0.76mm) upon exposure to an aqueous environment and body temperature. This may increase the delivery friction to deliver the implant to the target site.<\/p>\n

\u2022 In order to achieve optimal performance of the TrelliX Embolic Coil System and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between:<\/p>\n

\u2022 The femoral sheath and the guiding catheter<\/p>\n

\u2022 The microcatheter and the guiding catheter<\/p>\n

\u2022 The microcatheter and the TrelliX delivery pusher<\/p>\n

Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the TrelliX delivery pusher.<\/p>\n

\u2022 Advance and retract the TrelliX embolic coil slowly and smoothly, especially in tortuous anatomy. Remove the entire device if excessive friction is noted. If friction is noted in a second device, carefully examine both coil and the microcatheter for possible damage such a microcatheter shaft buckling or kinking.<\/p>\n

\u2022 Due to the delicate nature of the TrelliX embolic coils, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential coil breakage and migration.<\/p>\n

\u2022 If repositioning of the TrelliX embolic coil is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the delivery pusher. If the coil does not move in a one-to-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly migrate or break. Gently remove both the coil and microcatheter and replace with new devices.<\/p>\n

\u2022 Avoid placing the microcatheter within the aneurysm sac where the aneurysm wall may support the microcatheter positioning. This may increase the resistance required to deploy the implant into the aneurysm as the implant exits the catheter. Repositioning the distal tip of the microcatheter or placing the distal tip at the ostium of the aneurysm may be required.<\/p>\n

\u2022 If resistance is encountered while withdrawing a coil that is at an acute angle relative to the microcatheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at, or slightly inside, the ostium of the aneurysm. By doing so, the aneurysm and artery act to funnel the coil back into the microcatheter.<\/p>\n

\u2022 Multiple embolization procedures may be required to achieve the desired occlusion of some aneurysms or vessels.<\/p>\n

\u2022 Probability of occurrence of fluoroscopic complications may increase as procedure time and number of procedures increase.<\/p>\n

\u2022 Increased detachment times may occur when:<\/p>\n

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    Other embolic agents are present<\/p>\n<\/li>\n

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    Delivery pusher and microcatheter markers are not properly aligned<\/p>\n<\/li>\n

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    Thrombus is present on the coil detachment zone<\/p>\n<\/li>\n<\/ul>\n

    TrelliX\u00ae<\/sup> Detachment Controller<\/strong><\/h4>\n<\/div>\n<\/div>\n
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    Federal Law (USA) restricts this device to sale by or on the order of a physician.<\/p>\n

    \u2022 Prior to beginning a procedure, confirm that there are enough TrelliX Detachment Controllers available to complete the anticipated number of coil detachments. In addition, one (1) extra TrelliX Detachment Controller is required as backup for all procedures.<\/p>\n

    \u2022 Verify that the TrelliX Detachment Controller to be used is within its labeled shelf life.<\/p>\n

    \u2022 Batteries are preloaded into the TrelliX Detachment Controller. Do not attempt to disassemble the unit and replace the batteries.<\/p>\n

    \u2022 Increased detachment times may occur when:<\/p>\n

    \u2022 Other embolic agents are present<\/p>\n

    \u2022 Detachment zone is not properly positioned for detachment<\/p>\n

    \u2022 TrelliX delivery pusher and microcatheter markers are not properly aligned<\/p>\n

    \u2022 Thrombus is present on the detachment zone<\/p>\n

    \u2022 The TrelliX Detachment Controller\u2019s return electrode (grounding) cable is not attached firmly to the hypodermic needle, or the hypodermic needle is not placed properly within the tissue.<\/p>\n

    \u2022 Never insert a TrelliX delivery pusher into the TrelliX Detachment Controller\u2019s funnel unless it is free from fluids and debris, as this may permanently render the TrelliX Detachment Controller unusable for future detachments or impact the system to make proper electrical contact during detachment.<\/p>\n

    \u2022 Hypodermic (grounding) needle must be uncoated.<\/p>\n

    \u2022 If the TrelliX Detachment Controller is set on the table during a detachment cycle, take care to gently place it in a stable position so that it does not slide off of the delivery pusher during detachment. If the TrelliX Detachment Controller is held, take care to gently hold it in a stable position so that it does not slide off of the delivery pusher during detachment.<\/p>\n

    \u2022 Because coils are not always detached following completion of a cycle, ALWAYS verify for detachment under fluoroscopy prior to removing the TrelliX delivery pusher. Always confirm that the coil has detached by gently and slowly pulling back on the TrelliX delivery pusher while monitoring the fluoro image that there is no coil movement. In the unlikely event the coil moves (indicating attachment to the delivery pusher), check and adjust the flush system, flush the system to clear any contrast that may exist around the detachment zone, verify the system is properly grounded, realign the delivery pusher with the microcatheter, tighten the RHV, and repeat the detachment procedure.<\/p>\n

    \u2022 If detachment times are increasing and\/or the patient is experiencing pain at the needle insertion site, replace the needle with a new needle at a new insertion site.<\/p>\n

    \u2022 Portable and mobile RF communications equipment may affect the performance of the TrelliX Detachment Controller.<\/p>\n

    \u2022 If implant fails to detach, to minimize disturbance to the coil placement and delivery pusher, only press the \u201cDetach Button\u201d again to reinitiate. DO NOT remove or modify delivery pusher position.<\/p>\n<\/div>\n<\/div>\n

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    POTENTIAL ADVERSE EVENTS:<\/h2>\n

    IMPEDE\u00ae<\/sup> Embolization Plug, IMPEDE-FX Embolization Plug, & IMPEDE-FX RapidFill\u00ae<\/sup><\/h4>\n

    Potential adverse events that may occur during or after a procedure include, but are not limited to: Air embolus, Allergic reaction\/toxic effects, Bleeding, Death, Device migration, Fever, Foreign material embolic event, Hematoma, Hemolysis, Infection, Occlusion of unintended vessel, Peripheral embolism, Pulmonary embolism, Recanalization, Residual flow, Stroke\/TIA, Surgical intervention, Unintended thrombosis, Vascular access site complication, Vessel trauma\/perforation<\/p>\n

    TrelliX\u00ae<\/sup> Embolic Coil<\/h4>\n

    Potential adverse events that may occur during or after a procedure include, but are not limited to: Allergic reaction, Aneurysm perforation\/rupture, Arrhythmia, Coil migration or misplacement, Death, Dissection, Edema, Embolus, Headache, Hemorrhage, Hypertension, Hypotension, Incomplete aneurysm filling, Infection, Ischemia, Neurological\/intracranial sequelae, Parent artery occlusion, Post-embolization syndrome (fever, increase blood cell count, discomfort), Premature or difficult coil detachment, Revascularization, Stroke\/TIA, Trauma or damage, Vasospasm, Vessel perforation\/rupture, Vessel thrombosis, Other procedural complications including but not limited to: Access site complications, Access site hematoma, Anesthetic and contrast media risks, Risks associated with excessive fluoroscopic radiation such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.<\/p>\n

    TrelliX\u00ae<\/sup> Detachment Controller<\/strong><\/h4>\n

    Refer to the Instructions for Use for the TrelliX Embolic Coil System for potential adverse events associated with the coiling procedure. Although no adverse events are expected with the TrelliX Detachment Controller, failure to detach a coil may result in a longer procedure time, or additional interventional procedures. Please notify Shape Memory Medical Inc. immediately if the TrelliX Detachment Controller malfunctions or if patient injury is suspected as a result of using this system.<\/p>\n<\/div>\n<\/div>\n

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    \n

    CONTRAINDICATIONS:<\/h2>\n

    IMPEDE\u00ae<\/sup> Embolization Pug, IMPEDE-FX Embolization Plug, IMPEDE-FX RapidFill\u00ae<\/sup>, TrelliX\u00ae<\/sup> Embolic Coil, & TrelliX\u00ae<\/sup> Detachment Controller<\/h4>\n

    None known.<\/p>\n<\/div>\n<\/div>\n

    [\/vc_text_element][\/vc_column][\/vc_row][\/vc_section]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

    [vc_row min_height=”550px” content_placement=”middle” custom_bg_type=”image” custom_bg_cover=”cover” custom_bg_repeat=”no-repeat” custom_bg_position=”Center center” nav_skin=”light” consent_include=”include” equal_height=”true” el_design=”{“desktop“:{“padding-top“:“200“,“padding-bottom“:“100“}}” custom_bg_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” custom_bg_image=”676″][vc_column css_animation=””][vc_heading heading_text=”Indications, Safety & Warnings” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” heading_typography=”{“font_family“:“240743169“,“font_size“:“60px“,“line_height“:“1.2em“,“letter_spacing“:“-0.03em“}” responsiveness=”yes” tablet_portrait=”90″ mobile_landscape=”80″ mobile_portrait=”70″ css_animation=””][\/vc_column][\/vc_row][vc_section nav_skin=”light”][vc_row nav_skin=”light” consent_include=”include”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“40“,“padding-left“:“15“}}” css_animation=””][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”] INDICATIONS: IMPEDE\u00ae Embolization Plug The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. IMPEDE-FX Embolization Plug (US) In the United States, the IMPEDE-FX Embolization […]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-771","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nIndications, Safety & Warnings - Shape Memory Medical - Japan<\/title>\n<meta name=\"description\" content=\"The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. 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