What are the indications for use?
The device is intended for use in subperiosteal brow plastic surgery. The device is indicated for subperiosteal implantation for any brow lift procedure where anchoring is in the hair-bearing scalp. Although designed for endoscopic technique, the use of a bone anchored fixation system can also offer stability in open Browlifts.

What are the contraindications?

• Situations where internal fixation is otherwise contraindicated (e.g., infection).
• Patients appearing to have very thin bones which might imply an inadequate cranial thickness for the ENDOTINE Forehead device bone post which extends to a depth of 3.95 mm.
• Thin, atrophic scalp.
• Any known allergy or foreign-body sensitivities to plastic biomaterial.

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What are the clinical results?
Overall, the clinical results have demonstrated a remarkable level of ease-of-use and adjustment, as well as fixation stability. Some patients have reported sensitivity and palpability. To alleviate this side effect, the company has developed a lower profile model made of a co-polymer that resorbs more rapidly.

What are the advantages over absorbable screws and sutures?
Tests demonstrate greater ease-of-use and adjustability as well as significantly greater soft-tissue fixation/control with the multiple points of fixation found on the ENDOTINE device. Clinical results are preliminary but appear to show excellent fixation.

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What are the advantages over removable metal screws?
Metal percutaneous screws require early removal and may still cause alopecia. They also represent single points of fixation that may limit the brow shaping and stability that is possible.

What are the advantages over the bone tunnel technique?
All of the techniques for which the final common pathway is a suture suffer from potentially cumbersome placement as well as adjustability. Furthermore, the stability of fixation appears to be significantly less reliable than with the ENDOTINE device.

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What kind of instrumentation do I need?
Coapt Systems supplies an instrument kit that includes a specially designed drill bit and insertion tool.

Can I use my own drill?
You can use the ENDOTINE Drill Bit with most power drills and manual hand drills. It also will work with any drill that uses a universal adapter such as a Jacobs chuck. It is important to note that in cadaver laboratory tests have shown best results with relatively low speeds (<1000 RPM).

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To what depth does the drill penetrate?
The ENDOTINE device penetrates 3.95 mm into the cranial bone and designed such that the phalange on the post will sit between the calvarial tables in most adults. The depth may be excessive in patients with thin or fragile bones and thus should be avoided in such situations.

How do you know when the device is fully engaged in the cranium?
The device should sit flat without movement on the cranium when fully engaged. Often, a distinct “pop” can be felt and heard when the device engages into the bone.

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How hard do you need to push in order to engage the device fully?
Significant force is often required, accompanied by an audible “pop” when the device is fully engaged.

Can the drill penetrate the inner table?
One report of cadaveric craniums has suggested that patients with thin or fragile bones may be at risk for full thickness penetration. This is why such situations represent a clear contra–indication to the use of this device. To reduce the risk, the Company recommends that the holes be drilled anterior to the coronal suture and medial to the temporal fusion lines (but away from the sagittal suture). Here, the bone appears to be the thickest.

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What is the reason for the post diameter?
The post diameter was designed to offer a strong junction between the post and the device platform to minimize the chance of separation.

What side effects should I expect?
Occasionally, patients reported palpability and sensitivity over the device until it begins to absorb. Other side effects are typical of any implant.

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What kind of training is required?
The ENDOTINE Forehead is a simple device with a short learning curve. However, the Company recommends that your Coapt representative be present at the surgeon'’s first procedure to in–service staff and facilitate the proper use of the device.

How do I sign up for an evaluation?
Please feel free to contact your Coapt Customer Service Representative to schedule an evaluation. Our toll free telephone number is 1.800.963.7670.

LBL-899-7103 Rev B

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