The INVISx™ Cranial Fixation System is a unique, two-sided clamping cranial fixation device used for skull flap replacement following a craniotomy procedure.
INVISx Cranial Fixation System
Reusable trimming and tensioning instruments
The INVISx Cranial Fixation System is designed to assure the structural stability of the replaced skull flap following a craniotomy procedure. It is a unique, screwless cranial fixation system designed to reduce surgical time while maintaining flap closure strength.
The INVISx Cranial Fixation System consists of two locks made of polymer (plastic) material that are designed to fit within the osteotomy gap (kerf). These locks are then easily fixed in place using two ergonomically designed and reusable tools. Each INVISx Lock Assembly is designed to be implanted permanently. A lock consists of a superior cap interfaced with stem teeth, which gives the product strong fixation. The clover design enhances adaptability to the anatomy.
Lock assembly
Features of the INVISx Cranial Fixation System
Radiolucent – Permanent polymer (plastic) locks are CT- and MR-compatible, giving better image clarity
Adaptable – The polymer material and design of the INVISx locks contour to the patient’s cranial anatomy
Fast – Minimal number of steps required for cranial fixation
Easy to use – Reusable instruments are ergonomically designed
Cost-effective – Time saved in the OR may result in cost savings per procedure
Four steps of the INVISx cranial fixation procedure
With the INVISx Cranial Fixation System, locks and tools allow for
quickly re-attaching a cranial flap after a craniotomy. It is
indicated for use on adult skulls (those more than 2.5 mm thick) and
is not indicated for frontal and occipital areas. A minimum of four
locks are required to properly fixate a cranial flap.
The INVISx cranial fixation procedure can be
performed quickly with the following four steps:
Remove the cranial flap and place the INVISx locks
equidistantly around the opening.
Replace the cranial
flap.
Use the stainless steel Tensioning Instrument to
advance the cap down to the stem of the lock until enough pressure
has been applied to hold the flap in place.
Use the
stainless steel Trimming Instrument to trim the stem flush with the
top of the superior cap.
For complete instructions and details on applying (or removing) the
INVISx product, consult the Instructions
for Use or product brochure.
Important Safety Information
General risks may include infections, nerve damage,
hematomas, and impairment of wound healing. The patient should be made
aware of these risks and others associated with neurosurgery, general
surgery, and the use of anesthesia. At times the common complications
can provide serious risks and should be treated promptly as such. It
is important to review the product labeling for complete safety
information, potential complications, contraindications, and a
complete explanation of warnings and precautions.