Product

In the treatment of AIS patients, ApiFix is addresses the gap between the non-surgical treatments and the most invasive option of long spinal fusion.

 

ApiFix offers the “internal brace” alternative that can bring the spinal curve into the “safe zone”, below 35 degrees, and maintain it at that level.
The ApiFix Internal Brace System is attached to the spine via 2 pedicle screws that are inserted on both sides of the apex of the major curve. The incision is around 10 cm long and the procedure takes about one hour.
The expandable rod located between the two screws incorporates a miniature ratchet mechanism that captures incremental deformity corrections while the patient is performs side bending exercises to the corrective direction, at home, for 6 months after the operation.
Spanning the correction process over several months allows the soft tissues to accommodate any incremental correction. The long, incremental process reduces the load on the screws and allows the body to slowly rebuild itself in the correct position/shape.


 

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A patented control mechanism allows the surgeon  percutaneous access to a control feature that can lock or unlock the ratchet system at any time. If after skeletal maturity the curve is stable and will not collapse after releasing the ratchet mechanism, this is an indication that it is possible to remove the implant.
The ApiFix system also incorporates a unique Amorphous Diamond-Like Coating  (ADLC), a ceramic coating that minimizes friction and wear.
The ADLC coating is a material that inhibits bacteria growth,  thus reduces the risk of infection.

ApiFix Internal Brace Indications:

  • AIS patients classified as Lenke Type 1 or Type 5
  • Cobb angle from 40 to 60 degrees
  • Both major and secondary curves must be flexible (confirmed by Lateral Bending X-rays)
  • Minimal to moderate rotation
 

Expandable road

Cat no. Description
roadPIC AF65 65 mm length,
20 mm elongation
AF70 70 mm length,
20 mm elongation
AF75 75 mm length,
20 mm elongation
AF85 85 mm length,
30 mm elongation
AF95 95 mm length,
30 mm elongation
AF105 105 mm length,
30 mm elongation

Screws

Cat no. Description
screwPIC  AF6550 MID-C Pedicle Screw 6.5X50mm
 AF6545 MID-C  Pedicle Screw 6.5X45mm
 AF6540 MID-C  Pedicle Screw 6.5X40mm
 AF5545 MID-C  Pedicle Screw 5.5X45mm
 AF5540 MID-C  Pedicle Screw 5.5X40mm
 AF5535 MID-C  Pedicle Screw 5.5X35mm
 AF4540 MID-C  Pedicle Screw 4.5X40mm
 AF4535 MID-C  Pedicle Screw 4.5X35mm