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Indications, Safety & Warnings

INDICATIONS:

IMPEDE® 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 Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

IMPEDE-FX Embolization Plug (OUS)

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.

IMPEDE-FX RapidFill® (OUS)

In countries recognizing CE marking, the IMPEDE-FX RapidFill is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

IMPEDE-FX RapidFill is not available for sale in the U.S.

TrelliX® Embolic Coil (OUS)

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.

The TrelliX Embolic Coil is not available for sale in the U.S.

TrelliX® Detachment Controller (OUS)

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

The TrelliX Detachment Controller is not available for sale in the U.S.

WARNINGS:

IMPEDE® Embolization Plug

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.

• 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.

• 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.

• Do not use a power injection syringe to inject contrast solution through the device.

• Do not use after the “Use-by” date specified on the package.

• 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.

• 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.

IMPEDE-FX Embolization Plug

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.

• 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.

• 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.

• Do not use a power injection syringe to inject contrast solution through the device.

• Do not use after the “Use-by” date specified on the package.

• 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.

• 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.

IMPEDE-FX RapidFill®

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.

• 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.

• 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.

• Do not use a power injection syringe to inject contrast solution through the device.

• Do not use after the “Use-by” date specified on the package.

• 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.

• 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.

TrelliX® Embolic Coil

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.

• DO NOT use if the sterile package is open or damaged or if the system is damaged.

• DO NOT use after the “Use-by” date specified on the package.

• DO NOT attempt to re-sterilize or otherwise re-use.

• DO NOT advance the delivery pusher with excessive force.

• 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.

• Advancing the delivery pusher beyond the microcatheter tip once the coil has been detached involves risk of aneurysm or vessel perforation.

• 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.

• Damaged delivery pushers may cause vessel injury or unpredictable distal tip response during coil deployment.

• 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.

• DO NOT overtighten the RHV around the introducer sheath. Excessive tightening may cause damage to the device.

• 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.

• Microcatheter tip movement could cause the aneurysm or vessel to rupture.

• DO NOT place the TrelliX delivery pusher on a bare metallic surface.

• If implant fails to detach, to minimize disturbance to the coil placement and delivery pusher, only press the “Detach Button” again to reinitiate. DO NOT remove or modify delivery pusher position.

TrelliX® Detachment Controller

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’s device may lead to injury to the patient or user.

• DO NOT attempt to use the TrelliX Detachment Controller with another manufacturer’s devices due to potential incompatibility. Safety and performance have NOT been established with another manufacturer’s devices and is not recommended.

• 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.

• 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.

• DO NOT use after the “Use-by” date specified on the package.

• DO NOT use if labeling is incomplete or illegible.

• 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.

• There are no cables, transducers or other accessories that are likely to affect compliance of this equipment with the appropriate electro-magnetic standards.

• 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.

• 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.

• DO NOT advance the delivery pusher once the coil has been detached as it may increase risk of aneurysm or vessel perforation.

• 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.

• No modification of the device is allowed.

PRECAUTIONS:

IMPEDE® Embolization Plug

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.

• Physicians should exercise clinical judgment in situations that involve use of anticoagulants or antiplatelet drugs before, during, and/or after use of the device.

• 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.

• 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.

• 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.

• Verify temperature indicator label on front of pouch has not exceeded 40°C (105°F). 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.

• It is not recommended to wet the IMPEDE Embolization Plug prior to use. Exposure to an aqueous environment will impact the device working time.

• 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.

• 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.

• Refer to product label for device dimensions to determine vessel diameter compatibility. 2.0cm – 4.5cm of landing zone is recommended and physician discretion should be used during device selection.

IMPEDE-FX Embolization Plug

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

• 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).

• 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.

• 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.

• 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.

• 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.

• Verify temperature indicator label on front of pouch has not exceeded 40°C (105°F). If temperature indicator label shows temperature has been exceeded, do not use device as SMP Plug may have expanded impacting delivery performance.

• 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.

• 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.

• 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.

• Refer to product label for device dimensions to determine vessel diameter compatibility.

IMPEDE-FX RapidFill®

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

• 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).

• 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.

• 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.

• 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.

• 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.

• 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.

• Verify temperature indicator label on front of pouch has not exceeded 40°C (105°F). If temperature indicator label turns black, temperature has been exceeded. Do not use device as SMP Plug may have expanded impacting delivery performance.

• 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.

• 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.

• 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.

• Refer to product label for device dimensions to determine vessel diameter compatibility.

TrelliX® Embolic Coil

High quality, digital subtraction fluoroscopic road mapping is MANDATORY to achieve safe placement of the TrelliX Embolic Coil System.

• 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.

• 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.

• 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” (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.

• 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:

• The femoral sheath and the guiding catheter

• The microcatheter and the guiding catheter

• The microcatheter and the TrelliX delivery pusher

Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the TrelliX delivery pusher.

• 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.

• 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.

• 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.

• 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.

• 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.

• Multiple embolization procedures may be required to achieve the desired occlusion of some aneurysms or vessels.

• Probability of occurrence of fluoroscopic complications may increase as procedure time and number of procedures increase.

• Increased detachment times may occur when:

  • Other embolic agents are present

  • Delivery pusher and microcatheter markers are not properly aligned

  • Thrombus is present on the coil detachment zone

TrelliX® Detachment Controller

Federal Law (USA) restricts this device to sale by or on the order of a physician.

• 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.

• Verify that the TrelliX Detachment Controller to be used is within its labeled shelf life.

• Batteries are preloaded into the TrelliX Detachment Controller. Do not attempt to disassemble the unit and replace the batteries.

• Increased detachment times may occur when:

• Other embolic agents are present

• Detachment zone is not properly positioned for detachment

• TrelliX delivery pusher and microcatheter markers are not properly aligned

• Thrombus is present on the detachment zone

• The TrelliX Detachment Controller’s return electrode (grounding) cable is not attached firmly to the hypodermic needle, or the hypodermic needle is not placed properly within the tissue.

• Never insert a TrelliX delivery pusher into the TrelliX Detachment Controller’s 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.

• Hypodermic (grounding) needle must be uncoated.

• 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.

• 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.

• 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.

• Portable and mobile RF communications equipment may affect the performance of the TrelliX Detachment Controller.

• If implant fails to detach, to minimize disturbance to the coil placement and delivery pusher, only press the “Detach Button” again to reinitiate. DO NOT remove or modify delivery pusher position.

POTENTIAL ADVERSE EVENTS:

IMPEDE® Embolization Plug, IMPEDE-FX Embolization Plug, & IMPEDE-FX RapidFill®

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

TrelliX® Embolic Coil

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.

TrelliX® Detachment Controller

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.

CONTRAINDICATIONS:

IMPEDE® Embolization Pug, IMPEDE-FX Embolization Plug, IMPEDE-FX RapidFill®, TrelliX® Embolic Coil, & TrelliX® Detachment Controller

None known.

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