The INVISx™ Cranial Fixation System is a unique, two-sided clamping cranial fixation device used for skull flap replacement following a craniotomy procedure.
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.
Features of the INVISx Cranial Fixation System
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:
View a product demonstration of the INVISx Cranial Fixation System.
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.