What is the ENDOTINE TransBleph?
The ENDOTINE TransBleph is a bioabsorbable implant designed for a direct browpexy performed through an upper lid, blepharoplasty incision. It is composed of a co–polymer made of 82/18 L–lactide/glycolide. The implant consists of an anchoring post and fixation platform with three small tines. Included with each implant is a disposable drill bit and insertion tool. When implanted, the post is anchored to bone and the tines engage the periosteum and soft tissue of the brow.

What are the indications for use?
The device is intended for use in subperiosteal browplasty. The device is indicated for subperiosteal implantation for any brow lift procedure where stable anchoring of soft tissue over the brow bone is desired.

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 TransBleph drill bit which extends to a depth of 3.0 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.

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 kind of special instrumentation do I need?
The only special instrumentation required is a surgical drill. The ENDOTINE TransBleph comes packaged in a tray with a specially designed drill bit and insertion tool.

Can I use my own drill?
You can use the ENDOTINE Drill Bit with many power drills and manual hand drills. It works with any drill that uses a universal adapter such as a 3 Jaw Jacobs chuck. It is important to note that 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 into the cranium bone 3.0 mm. The depth may be excessive in very thin boned 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.

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How hard do you need to push in order to engage the device fully?
Significant force is often required.

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; the device is contraindicated for these patients.

What are my chances of penetrating a sinus?
Sinuses are generally located medially to the typical location of the TransBleph post. However, in some patients it is possible to penetrate a sinus.

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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 TransBleph 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 inservice staff and facilitate the proper use of the device.

How do I sign up for an evaluation?
Our toll free telephone number is 1.800.963.7670. We will be happy to help you contact your local Coapt representative to schedule an evaluation.

LBL-899-7116 Rev A

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