Axium™ MicroFX™ coils with LatticeFX™ technology have overlapped individual nylon or PGLA microfilaments between coil loops, forming an intra-aneurysmal surface area for stable scar tissue formation and high thrombogenicity.

These coils provide the acute performance of an Axium™ Bare coil with the added benefit of LatticeFX™ technology.

• Flow reduction across the neck. 
• Increased thrombogenicity.
• 33% less flow through MicroFX™ coils vs. standard Axium™ coils.

KEY BENEFITS OF AXIUM™ MICROFX™ COILS

INTERLOCKED SURFACE AREA

Polymer fibers: Axium™ MicroFX™ coils contain PGLA or nylon microfilaments designed to impact flow reduction and accelerate thrombosis.

LatticeFX™ Technology: LatticeFX™ technology provides an interlocked surface area or scaffold which orients cell adhesion and extracellular deposition.

ACCELERATED THROMBUS FORMATION

Enhanced thrombin generation with filamented coils when compared to bare platinum coils and higher thrombogenicity may be beneficial in situations where rapid occlusion is needed.

VESSEL OR FISTULA TAKE DOWN

An alternative to bare platinum coils for arteriovenous fistulae and other neurovascular abnormalities.

Axium™ and Axium™ MicroFX™ detachable coil systems are indicated for the endovascular embolisation of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

WARNINGS

• The AXIUM™ Detachable Coil and 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™ Detachable Coils or damaged AXIUM™ PRIME Detachable Coils must not be used, as they may result in patient injury.
• AXIUM™ Detachable Coils and AXIUM™ PRIME Detachable Coils are intended for one use only. The I.D. (Instant Detacher) is supplied sterile and intended for single patient use. After use do not resterilise and/or reuse. Reprocessing or resterilisation 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 in an attempt to advance delivery pusher. This may result in a kinked pusher which may lead to premature detachment.
• Verify that the distal shaft of the microcatheter is not under stress before AXIUM™ Detachable Coil detachment or the AXIUM™ PRIME Detachable Coil detachment. Axial compression or tensile forces could be stored in the microcatheter causing the tip to move during AXIUM™ Detachable Coil delivery or during 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™ Detachable Coil or 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™ Detachable Coil or 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 catheterisation of the aneurysm or vessel and correct placement of the first coil. With smaller aneurysms this is a particularly important step.
• If AXIUM™ Detachable Coil or 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™ Detachable Coil and 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™ Detachable Coil or 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™ Detachable Coils or 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 supplied STERILE for single use only. Do not reprocess or re-sterilise. Reprocessing and re-sterilisation increase the risks of patient infection and compromised device performance.
• For Axium™ Detachable Coils: Do not use the product if the temperature indicator on either the pouch or the carton box is red. A red indicator means the product has been exposed to temperature greater than 50° C (122° F). Use of the product which has been exposed to temperature greater than 50° C (122° F), may compromise patient safety.