What is the ENDOTINE Midface™ ST 4.5 device?
What are the indications for use?
What are the contraindications?
What are the clinical results?
How is the device used?
What kind of instruments do I need?
What type of suture do I use to anchor the leash to the deep temporal fascia?
How long does the implant remain palpable?
What are the advantages of the ENDOTINE Midface device?
What kind of training is required?
What are the device side effects?
How do I sign up for an evaluation?

What is the ENDOTINE Midface™ ST 4.5 device?
The ENDOTINE Midface is a bioabsorbable implant designed for subperiosteal midface suspension. It is made of 82/18 L-lactide/glycolide, similar to LactoSorb™, and consists of a platform with five tines, a long slender leash, and disposable insertion tools. When implanted, the platform tines engage subperiosteal cheek tissue and the leash is tensioned and sutured to the deep temporal fascia. The Endotine Midface replaces conventional suspension suture used in midface suspension surgery.

What are the indications for use?
The ENDOTINE Midface ST device is intended for use in subperiosteal midface suspension to fixate cheek subermis tissue in an elevated position. The device consists of disposable insertion tools and a bioabsorbable implant.

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What are the contraindications?

• Situations where internal fixation is otherwise contraindicated (ie. infection)
• Patients appearing to have very thin soft tissues of the face in which the implant may be visible or palpable
• Any known allergy or foreign-body sensitivities to plastic biomaterial

What are the clinical results?
The device has been in use since Fall 2003, and has proven to be easy to use with reliable suspension and placement of cheek tissue. The device is palpable in some cases, but not visible.

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How is the device used?
The ENDOTINE Midface is designed for insertion through a temporal incision, or in a retrograde fashion, through a buccal sulcus approach.

Most surgeons use an endoscope to complete the dissection from the temporal region to the midface. The dissection is carried down to the deep temporal fascia and then inferiorly to the zygoma. At this point, the midface is entered in a subperiosteal plane. The dissection is often completed, under direct vision, through the oral incision.

Regardless of insertion approach, the device platform should ultimately lie over the maxillary antrum, and not over the zygoma.

If using the temporal approach, the device platform and tines are exposed by triggering the simple release mechanism on the insertion tools. The insertion tools are then removed, leaving the leash exposed in the temporal incision. The leash is tensioned to achieve desired cheek elevation and then sutured to the deep temporal fascia.

If using the oral approach, the device is removed from the insertion tools and pulled into position with the aid of graspers, forceps, or suture passed through the temporal incision. Oral insertion may be facilitated by trimming the corners of the leash end in order to smooth the leading edge.

What kind of instruments do I need?
No specialized instruments are required. Many surgeons do elect to use an endoscope to aid in visualization during dissection.

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What type of suture do I use to anchor the leash to the deep temporal fascia?
Absorbable or permanent suture of sufficient strength should be used.

How long does the implant remain palpable?
The implant material is essentially resorbed within twelve months of implantation. In-vitro studies have demonstrated 95% strength loss and 50% mass loss at five months.

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What are the advantages of the ENDOTINE Midface device?
Fast, adjustable, and secure, the ENDOTINE Midface offers predictable control of midface volume enhancement and projection, enabling improved aesthetic outcomes. The ENDOTINE Midface is an absorbable implant with multiple tines (five) that distribute tension over a broader surface area than the single point of fixation of most suture suspension techniques. In experienced hands, the device can be placed in five minutes or less, saving valuable OR time. The device is easy to position, deploy, and reposition if necessary, without the frustration of passing suture or frequent skin dimpling. The five points of tissue contact virtually eliminate device/tissue pull through, which can be seen with suture techniques. Also, the ENDOTINE Midface is easily and reliably anchored to the deep temporal fascia, providing the surgeon with assurance that the cheek suspension will be maintained.

What kind of training is required?
The ENDOTINE Midface device is simple, reliable, intuitive and easy to master. The company does recommend that your Coapt representative be present at your first case to emphasize proper use of the device and to in-service your staff.

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What are the device side effects?
The ENDOTINE Midface will likely be palpable in the post-operative period. This will diminish as the device is gradually resorbed. Also, some patients may experience sensitivity or tenderness over the device, although this has not been a problem so far.

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.

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