Ultratine - AFS Medical
Ultratine - AFS Medical
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.