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Ultratine - AFS Medical

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Ultra-secure forehead soft tissue fixation<br />

TM<br />

ULTRATINE<br />

The ultimate in patient comfort


Why The New <strong>Ultratine</strong> TM<br />

Surgeons have asked us for a more rapidly absorbing Endotine<br />

Forehead. One that holds the forehead soft tissue with as much security<br />

and placement control as the current Endotine, but provides more<br />

comfort to their patients during the post surgical phase. We are pleased<br />

to introduce <strong>Ultratine</strong> to answer this need.<br />

The <strong>Ultratine</strong> Forehead consists of a similar, but uniquely different<br />

polylactic acid and polyglycolic acid polymer blend that bio-absorbs in a<br />

more desirable way. The structure of the material quickly flattens under<br />

the skin as periosteal attachment is complete, greatly enhancing the<br />

patient’s post operative experience.<br />

<strong>Ultratine</strong> versus Endotine ® Absorption Profile<br />

Biologic Fixation<br />

% Strength<br />

100<br />

Periosteal Attachment<br />

80<br />

Endotine 82:18<br />

60<br />

<strong>Ultratine</strong><br />

40<br />

20<br />

Time (weeks)<br />

0 2 4 6 8 10 12 14 16 18 20<br />

<strong>Ultratine</strong> Key Performance Traits:<br />

• <strong>Ultratine</strong> loses 90% of its strength in 60 days, while Endotine loses<br />

only 37% of its strength in 60 days<br />

• <strong>Ultratine</strong>’s rapid strength degradation after periosteal attachment<br />

is complete means the patient has less palpability and sensitivity<br />

after 60 days


<strong>Ultratine</strong> TM<br />

Performance<br />

<strong>Ultratine</strong> Performance and Satisfaction Exceeds Expectations<br />

When we identified the right material for <strong>Ultratine</strong>, we tested it for clinical<br />

performance, and surgeon and patient satisfaction with the overall<br />

experience with the device. The objective was to achieve seamless product<br />

performance and high levels of patient satisfaction. The results of a 22<br />

patient study are summarized below.<br />

<strong>Ultratine</strong> demonstrates a high degree of surgeon<br />

satisfaction and patient comfort<br />

MEASURE 30 DAYS 90 DAYS<br />

Maintaining Elevation<br />

➔ Very Satisfied/Satisfied 95.4 95.4<br />

Palpability<br />

➔ Palpable/Slightly Palpable 77.3 95.4<br />

Use <strong>Ultratine</strong> Instead of Endotine<br />

➔ Yes 95.5 90.9<br />

Patient Satisfaction<br />

➔ Very Satisfied/Satisfied 86.4 91.0<br />

*Data on file at Coapt Systems<br />

What Our Customers are Saying<br />

“For properly selected patients,<br />

<strong>Ultratine</strong> has proven to be as<br />

effective as Endotine in<br />

maintaining elevation of the<br />

brow. The device is perceived<br />

by patients to be more<br />

comfortable than Endotine.”<br />

DR. R. LAURENCE BERKOWITZ<br />

Santa Clara, California<br />

“<strong>Ultratine</strong> provides the stability<br />

needed for periosteal reattachment<br />

to its newly elevated position. The<br />

rapid absorption of <strong>Ultratine</strong> means<br />

better patient comfort post-operatively<br />

with less sensitivity and palpability.”<br />

DR. JEFFREY JOSEPH<br />

Lafayette, Louisiana


The Importance of Fixation<br />

Research has proven fixation is a key element in a<br />

successful forehead lift.<br />

Aesthetic thought leaders have published data that four to six weeks is<br />

required for forehead periosteal reattachment:<br />

Periosteal Re-Attachment—<br />

Clinical Experience<br />

Periosteal Re-Attachment<br />

in Animal Models<br />

David Knize, MD<br />

“Brow Fixation with the Endotine Forehead Device in<br />

Endoscopic Brow Lift”<br />

Plastic & Reconstructive Surgery, Vol. 116, No. 6<br />

Periosteum: 10 to 14 days<br />

Lateral Brow and Temporal Fascia: At least 30 days<br />

Sean Boutros, MD, et al.;<br />

“The Temporal Sequence of Periosteal Attachment<br />

After Elevation”<br />

Plastic and Reconstructive Surgery 111: 1942,<br />

2003– 30 DAYS<br />

Thomas Romo III, MD, et al.;<br />

“Strength and Histological Characteristic of Periosteal<br />

Fixation to Bone After Elevation”<br />

Plastic and Reconstructive Surgery 2000; 105:1111-7<br />

Minimum 6 weeks– Complete at 12 weeks<br />

The <strong>Ultratine</strong> Difference<br />

• Sutureless fixation providing rapid deployment and secure soft<br />

tissue repositioning<br />

• Adjustable tissue placement for complete control of<br />

aesthetic outcomes<br />

• Multiple points of soft tissue fixation for a balanced<br />

distribution of tissue tension<br />

• Bioabsorbable co-polymer holds elevated tissue in the new<br />

position until biological healing takes place<br />

ENDOSCOPIC APPLICATION<br />

SUTURE<br />

ULTRATINE


The <strong>Ultratine</strong> Forehead Lift Procedure<br />

THE PROCEDURE:<br />

1<br />

MAKE THE INCISION<br />

Make the coronal or limited<br />

incision in your usual fashion.<br />

Perform the dissection and<br />

elevate the brow.<br />

2<br />

DETERMINE THE DRILL HOLE SITE<br />

Plan the drill hole sites such that<br />

the <strong>Ultratine</strong> Forehead devices<br />

will sit anterior to the incisional<br />

closure and under hair bearing<br />

scalp.<br />

3<br />

MAKE THE HOLE<br />

Use the <strong>Ultratine</strong> Forehead drill<br />

bit to create a hole at the drill<br />

hole site. Drill all the way to the<br />

drill bit sleeve. Suction the bone<br />

hole to remove all debris.<br />

4<br />

GRASP THE DEVICE<br />

Use the <strong>Ultratine</strong> Forehead<br />

Insertion Tool to grasp the<br />

implant and remove it from its<br />

packaging. One needle-like tip of<br />

the tool fits into the hole in the<br />

UltraTine Forehead platform and<br />

the other end grasps the<br />

implant post.<br />

5<br />

PLACE THE DEVICE<br />

Insert the <strong>Ultratine</strong> Forehead<br />

implant into the drilled hole.<br />

Push until the platform is flush<br />

with the cranium. Release the<br />

Insertion Tool from the implant.<br />

6<br />

ELEVATE THE TISSUE<br />

Elevate brow tissue to desired<br />

position. Readjust as desired for<br />

optimal aesthetic effect.<br />

7<br />

SECURE THE TISSUE<br />

Apply digital pressure to ensure<br />

penetration of the tissue by the<br />

device tines. Close the incision.<br />

Excise scalp as necessary for a<br />

tension free closure.


3.0mm is designed for patients with below<br />

average scalp thickness. This <strong>Ultratine</strong> uses tines<br />

that are 3.0mm in height to further reduce issues<br />

of palpability or sensitivity.<br />

3.5mm features tines that are 3.5mm in height<br />

and is best for patients with average to thick<br />

scalps where more secure fixation<br />

is desired.<br />

Materials Needed for an <strong>Ultratine</strong> Forehead Lift Procedure<br />

CAT # PRODUCT NAME PRODUCT DESCRIPTION QUANTITY<br />

23200 <strong>Ultratine</strong> Forehead 3.0 Bioabsorbable brow fixation device 1 each<br />

with 3.0mm tine height<br />

23100 <strong>Ultratine</strong> Forehead 3.5 Bioabsorbable brow fixation device 1 each<br />

with 3.5mm tine height<br />

CFD-010-4320 Forehead Instrument Kit Forehead insertion tool, drill bits, 1 each<br />

sterilization tray with lid<br />

CFD-899-4000 Coapt Manual Surgical Drill Manual surgical hand drill for use 1 each<br />

with Endotine implants<br />

THIS PRODUCT IS COVERED BY ONE OR BOTH OF THE FOLLOWING U.S. PATENTS: 6,645,226 AND 6,485,503.<br />

Coapt Systems, Inc.<br />

1820 Embarcadero Road<br />

Palo Alto, CA 94303<br />

800.963.7670 Toll Free<br />

650.213.9377 Fax<br />

www.coaptsystems.com<br />

© 2007 Coapt Systems, Inc. All rights reserved. The Coapt logo, Coapt, ENDOTINE and <strong>Ultratine</strong> are trademarks and/or<br />

registered trademarks of Coapt Systems, Inc. LBL-899-7136 Rev A.

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