What is the ENDOTINE Midface™ B 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?
How long does the implant remain palpable?
What are the advantages of the ENDOTINE Midface B
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™ B 4.5 device?
The ENDOTINE Midface B 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 slender
leash, and reusable insertion tools. When implanted, the platform tines
engage subperiosteal cheek tissue and the leash is anchored to the supraorbital
rim/zygoma with a bioabsorbable screw. The Endotine Midface B replaces
conventional suspension suture used in midface suspension surgery.
What are the indications for use?
The ENDOTINE Midface B device is intended for use in subperiosteal
midface suspension to fixate cheek subermis tissue in an elevated position.
The device consists of a bioabsorbable implant and two bioabsorbable
anchor screws.
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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 Endotine Midface fixation platform with five tines has been in clinical
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 B is designed for insertion through a lower-lid,
blepharoplasty incision.
The dissection is carried out inferiorly from the lower lid blepharoplasty
incision down to the zygoma. At this point, the midface is entered in
a subperiosteal plane. The dissection is usually completed, under direct
vision, through the incision.
Once the midface dissection is completed, the ENDOTINE Midface B device
implant is inserted downward through the incision. Digital pressure
on the cheek quickly engages the tines into the soft tissue. Once the
tines are engaged, the leash is tensioned to achieve the desired cheek
elevation. While under tension, an anchor point on the infraorbital
rim is marked. A small hole is then drilled and tapped at the marked
location. The leash is then re-tensioned to the desired elevation and
the screw anchor is placed to anchor the leash to the infraorbital rim.
The screw anchor head and excess leash is then trimmed.
What kind of instruments do I need?
To implant the ENDOTINE Midface B, you must have access to the ENDOTINE
Midface B Instrument Kit. This kit contains the drill bit, tap, screw-anchor
insertion tool and clipper, all of which were specifically designed
for use with the ENDOTINE Midface B implant. Many surgeons do elect
to use a lighted, hand-held retractor during the midface dissection.
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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
B device?
Fast, adjustable, and secure, the ENDOTINE Midface B offers predictable
control of midface volume enhancement and projection, enabling improved
aesthetic outcomes. It eliminates fixation suture while providing a
vertical vector of lift for the midface tissues. Since dissection is
performed under direct visualization, no endoscopic equipment is required.
The ENDOTINE Midface B is an absorbable implant with multiple tines
(five) that distribute tension over a broader surface area than the
single point of fixation suture. 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 B is
easily and reliably anchored to the infraorbital rim, 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 B 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.
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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