Detachable coils

Axium™ Prime extra soft coil

<p>The Axium™ Prime Extra soft detachable coil is designed to maximize packing without sacrificing softness in treating intracranial aneurysms.<sup>18</sup></p>

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Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.

Features

Axium™ coil family provides optimal implant designs for a variety of coiling procedures with our framing, filling, and finishing coils. Axium™ products provide proven softness, high-volume packing, minimal kickback, and exceptional detachment.^{◊,3,4,7–11}

99.7%

Proven reliability with first attempt detachment success^10–12

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 percutaneous neurointerventional procedures.

Indications for useThe Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Precautions

Handle the Axium™ Prime Detachable Coil with care to avoid damage before or during treatment.

Do not advance the Axium™ Prime Detachable Coil against a noted resistance until the cause of the resistance is cleared by fluoroscopy. This may lead to the destruction of the coil and/or catheter or perforation of the vessel.

It is essential to confirm catheter compatibility with the Axium™ Prime Detachable Coil. The outer diameter of the Axium™ Prime Detachable Coil should be checked to ensure that the coil will not block the catheter.

The dispenser track, introducer sheath and the Instant Detacher (I.D.) are not intended to make contact within the patient.

Do not use the Axium™ Prime Detachable Coil and the Instant Detacher (I.D.) after the expiration date printed on the product label.

In order to achieve optimal performance of the Axium™ Prime Detachable Coil and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained.

Advance and retract Axium™ Prime Detachable Coils slowly and smoothly, especially in tortuous anatomy. Remove the coil if unusual friction or “scratching” is noted. If friction is noted in a second coil, carefully examine both the coil and the catheter for possible damage such as catheter shaft buckling or kinking, or an improperly fused joint.

If delivery pusher buckling or kinking is noted, grasp the distal most portion of the delivery pusher, distal to the kink, buckle or break and remove from microcatheter.

Do not advance the coil with force if the coil becomes lodged within or outside the microcatheter. Determine the cause of resistance and remove the system when necessary.

If resistance is encountered when withdrawing the implant delivery pusher, draw back on the infusion catheter simultaneously until the delivery pusher can be removed without resistance.

If resistance is noted during coil delivery, remove the system and check for possible damage to the catheter.

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.

Operators should 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.

Magnetic Resonance Imaging (MRI) Safety InformationNon-clinical testing and electromagnetic/thermal modeling demonstrated that the implanted Axium™ Prime Detachable Coil is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

Parameter

Condition of Use/Information

Static Magnetic Field Strength (B₀) [T]

1.5T, 3T

Type of Nuclei

Hydrogen Proton

Static Magnetic Field (B₀) Orientation Parameter

Horizontal, Cylindrical bore

Maximum Spatial Field Gradient (SFG) [T/m] and [gauss/cm]

40 T/m (4000 gauss/cm)

RF Polarization

Circularly Polarized (CP)

RF Transmit Coil

Integrated Whole Body Transmit RF Coil Detachable Extremity Transmit/Receive RF coil

RF Receive Coil

Any receive-only RF coil may be used

MR System (RF) Operating Modes or Constraints

Normal Operating Mode

Whole Body Averaged SAR [W/kg]

≤ 2 W/kg

Head SAR [W/kg]

≤ 3.2 W/kg

Scan Duration

Scan for 60 minutes with one or more MR imaging sequences followed by a wait time of 30 minutes before resuming scanning.

Anatomy at Isocenter

Any anatomic location at isocenter is acceptable

Patient position in scanner

Any patient position is acceptable

Item Configuration

In non-clinical testing, the magnetically induced displacement force and magnetically induced torque were tested and zero displacement and zero torque was measured.

MR Image Artifact

In non-clinical testing, the image artifact caused by the implanted Axium™ Prime Detachable Coil extends approximately 5-mm from the coil when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.

Potential complicationsPotential complications of the device and the endovascular procedure include or are synonymous with, but may not be limited to:

Access site complications such as radial artery spasm, radial artery perforation, vessel occlusion, arteriovenous fistula, hematoma or hemorrhage, intimal damage, granuloma, infection, sterile inflammation, necrosis, nerve damage, pain and tenderness, compartment syndrome, pseudoaneurysm, pathological hand cold intolerance

Adverse reactions to antiplatelet/ anticoagulation agents, contrast media, or anesthesia such as aspiration, hypersensitivity, hypotension, nausea

Cardiac complications such as arrhythmia, myocardial infarction

Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia

Device complications such as fracture, stretched coil, kink, premature detachment, non-detachment, foreign body in patient

Hematologic complications such as thrombosis, hemolysis, hemorrhage, intracranial hemorrhage

Hydrocephalus

Neurological deficits/dysfunction including emotional changes, paresis, stroke, ischemia, hand dysfunction

Systemic complications such as fever, infection, inflammation, edema, shock, toxicity, foreign body reaction, organ failure, hypertension

Therapeutic response decreased

Vascular complications such as dissection, perforation, rupture, vasospasm, stenosis, necrosis, occlusion, fistula, embolism, gas embolism, thromboembolism, abscess

Vision symptoms such as blurred vision, vision loss

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.Warnings

Do not use hemostats or a torquer in an attempt to advance delivery pusher. This may result in a kinked/damaged pusher which may lead to premature detachment.

If attempt to detach fails, remove coil from treatment area and microcatheter and replace with a new Axium™ Prime Detachable Coil under fluoroscopy.

If coil becomes prematurely detached, remove implant pusher and confirm under fluoroscopy:

Advance next coil to push remaining tail of prematurely detached coil into treatment area.
Remove prematurely detached coil with the appropriate retrieval device.

Do not resterilize the Instant Detacher (I.D.). For Single Patient use only.

The Instant Detacher (I.D.) is intended for a maximum of 25 cycles.

The Axium™ Prime Detachable Coil, the dispenser track, and the introducer sheath are supplied in a sterile and non-pyrogenic, unopened and undamaged package. The package should be checked for potential damage. Damaged Axium™ Prime Detachable Coils must not be used, as they may result in patient injury.

Axium™ Prime Detachable Coils are intended for single use only. The Instant Detacher (I.D.) is intended for single use only. After use do not resterilize and/or reuse. Reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn, may result in patient injury, illness or death.

Do not use if sterile packaging has been compromised or damaged.

Damaged implant delivery pusher and/or coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration or stretching.

Do not rotate the implant delivery pusher during or after delivery of the coil into the aneurysm. Rotating the delivery pusher during or after coil delivery into the aneurysm may result in a stretched coil or premature detachment of the coil from the implant delivery pusher, which could result in coil migration.

Do not use hemostats or a torquer in an attempt to advance delivery pusher. This may result in a kinked/damaged pusher which may lead to premature detachment.

Verify that the distal shaft of the microcatheter is not under stress before the Axium™ Prime Detachable Coil detachment. Axial compression or tensile forces could be stored in the microcatheter causing the tip to move during the Axium™ Prime Detachable Coil delivery. Microcatheter tip movement could cause the aneurysm or vessel to rupture.

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

If undesirable movement of the Axium™ Prime Detachable Coil can be seen under fluoroscopy following coil placement and prior to detachment, remove the coil and replace with another more appropriately sized Axium™ Prime Detachable Coil. Movement of the coil may indicate the coil could migrate once it is detached. Angiographic controls should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.

High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe catheterization of the aneurysm or vessel and correct placement of the first coil. With smaller aneurysms this is a particularly important step.

If Axium™ Prime Detachable Coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the implant pusher. If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break. Gently remove and discard both the catheter and coil.

Due to the delicate nature of the Axium™ Prime Detachable Coil, 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 malfunctions such as coil breakage and migration.

If resistance is encountered while withdrawing an Axium™ Prime Detachable Coil, which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery.

Take care not to puncture gloves or sterile drape while handling implant delivery pusher.

Multiple placements of Axium™ Prime Detachable Coils may be required to achieve the desired occlusion of some aneurysms or vessels.

The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.

This device is intended for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance.

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.

Nickel (CAS No. 7440-02-0) is a tested material and/or substance that can cause sensitization or an allergic reactions in some patients.

The Delivery System contains cobalt (CAS No. 7440-48-4), present at a concentration >0.1% weight/weight. Cobalt is classified as an endocrine disruptor (ED) or as a carcinogen, mutagen, or substance toxic for reproduction (CMR) of Category 1A or 1B.

Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in sterile barrier system integrity are evident.

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

Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device or viewed at www.medtronic.com/manualsUS-NEU-2400073 (v1.0)

Better trackability through tortuous anatomy^¶,13-15

Distal tapered pusher design allows for increased articulation and enhanced trackability^14,16