Make GYNECARE THERMACHOICE III Your Choice
®
Make GYNECARE THERMACHOICE ® III Your Choice
…for effective treatment of
your patients
…for an effective solution to
stop heavy bleeding
Ordering Information
The Evolution of
GYNECARE
THERMACHOICE®
Patient Report
Comparisons*
TODAY
GYNECARE THERMACHOICE III
®
has a conforming balloon which
GYNECARE
THERMACHOICE® III6
NovaSure
Patients returning
to normal levels of
menstrual bleeding
or lower
81%
78%
Patients experiencing
amenorrhea at
12 months
37%
Patients reporting
satisfaction
96%
Patients experiencing
reduction in
dysmenorrhea
89%
®3
Her Option
HTA®
System7
67%
68%
36%
®9
22%
35%
leads to improved coverage,
treatment and efficacy 8
1999
92%
86%
88%
N/A
is introduced, providing a
silicone balloon material and
fluid circulation
Percent of Evaluable Patients Returning to
Normal Levels of Menstrual Bleeding or Lower
94% of patients
1997
treated with GYNECARE
THERMACHOICE ® III 2
GYNECARE THERMACHOICE ® I
GYNECARE THERMACHOICE
Uterine Balloon Therapy Catheter
Sterile, single use catheters
TC003..............................................................Box of 5
TC013..............................................................Single pack
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
89% of patients in a
63%
91% of patients
vs.
treated with NovaSure®10
study* had a reduction
in menstrual pain
and cramping 6
9 out of 10 women
avoided hysterectomy
at 3 years11
In a study,
99% would
recommend the
procedure to
other women 6
the first GEA device,
is introduced
Description
®
N/A
*Based on Intent-To-Treat population
3. NovaSure. Instructions for use. © 2004, Cytyc Corporation.
6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc.
7. Hydro ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation.
9. Her Option. Instructions for use. © 2006 American Medical Systems, Inc.
N/A=not available
GYNECARE THERMACHOICE ® II
Product Code
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
A division of ETHICON, INC.
a Johnson & Johnson company
© ETHICON, INC. 2008
TC138 • 10/08
GYNECARE THERMACHOICE ®
Uterine Balloon Therapy System
00825 ..............................................................Controller
01105 ..............................................................Umbilical Cord
04995 ..............................................................Power Cord
CPT Code Information
Code Number
Description
58563 ................Endometrial ablation with hysteroscopy
58353 ................Endometrial ablation without hysteroscopy
64435 ................Injection, anesthetic agent; paracervical
(uterine) nerve
For reimbursement support,
please call the ETHICON
Reimbursement Hotline at
1-800-964-8496.
If offering in the office, ensure utilization of Site of Service Code 11.
GYNECARE THERMACHOICE® Uterine Balloon Therapy System
Essential Product Information
INDICATIONS: The GYNECARE THERMACHOICE® UBT System is a thermal balloon ablation device intended to ablate the
endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes
for whom childbearing is complete. CONTRAINDICATIONS: The device is contraindicated for use in a patient: who is pregnant
or who wants to become pregnant in the future; with known or suspected endometrial carcinoma (uterine cancer) or premalignant
change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which
weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy;
with active genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis);
with an intrauterine device (IUD) currently in place. ADVERSE EVENTS include: rupture of the uterus; thermal injury to adjacent
tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical
burn; hemorrhage; infection or sepsis; perforation; post-ablation-tubal sterilization syndrome; complications leading to serious
injury or death; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the
fetus); vesico-uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with
hysteroscopy. WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious
patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur
if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal
ligation are at increased risk of developing post-ablation-tubal sterilization syndrome which can require hysterectomy.
Endometrial ablation procedures using the GYNECARE THERMACHOICE® UBT System should be performed only by medical
professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and
curettage (D&C), and who have adequate training and familiarity with GYNECARE THERMACHOICE® UBT System.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® UBT System. Refer to package insert
for complete product information including warnings, precautions, and adverse reactions. RX Only.
THE INFORMATION CONTAINED IN THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENTS NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon
Women's Health & Urology CONCERNING LEVELS OF REIMBURSEMENT, PAYMENT, OR CHARGE.
SIMILARLY, ALL CPT (COPYRIGHT AMA) AND HCPCS CODES ARE SUPPLIED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENT NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon Women's
Health and Urology THAT THESE CODES WILL BE APPROPRIATE OR THAT REIMBURSEMENT
WILL BE MADE. IT IS NOT INTENDED TO INCREASE OR MAXIMIZE REIMBURSEMENT BY ANY
PAYOR. WE STRONGLY RECOMMEND THAT YOU CONSULT YOUR PAYOR ORGANIZATION WITH
REGARD TO ITS REIMBURSEMENT POLICIES.
…for customized coverage.
…to help end heavy periods.
Make GYNECARE THERMACHOICE ® III Your Choice
…designed for safe treatment
…for lasting pain reduction
over time
…for more complete coverage
2
• Conforms to most uterine shapes and sizes with no reduction of efficacy
• Can be done under local anesthesia
Conforms to Most Uterine Shapes and Sizes
With No Reduction of Efficacy
Dysmenorrhea and Menorrhagia May Go Hand-in-Hand
• Requires minimal, if any, dilation
In clinical trials of the leading global endometrial ablation systems, data suggest
that dysmenorrhea and menorrhagia co-exist in up to 93% of patients with
documented menorrhagia at study enrollment.3,4,5
• Safety mechanisms are built in throughout the procedure to minimize
the occurrence of harmful incidents
• Fluid is contained in flexible and non-allergenic material
GYNECARE THERMACHOICE ® Effectively Decreased
Long-term Dysmenorrhea2
– hormones
– radio frequency
– the need for IV sedation
Her Option®
NovaSure®
& HTA®
• Over 30% reported only mild pain associated with menses
Microsulis
Fewer Patients Experienced Menstrual Pain at 3 and 5 Years2
5 mm
6 mm
8 mm
• 26% less untreated corneal tissue
• Improved coverage of the lower uterine segment
• Over 50% reported no pain associated with menses
GYNECARE
THERMACHOICE®
• More even necrosis of tissue throughout the entire endometrium
After five years:
Smaller dilation compared to 3 leading brands
Uterine Balloon Therapy System
Based on ex vivo Studies7 vs. the Previous Balloon
At one-year and three-year follow-up, nearly 3 out of 4 women surveyed
who were treated with GYNECARE THERMACHOICE ® reported reductions
in dysmenorrhea.2
9 mm
Her Option® is a registered trademark of American Medical Systems.
NovaSure® is a registered trademark of Cytyc Corporation.
HTA® System is a registered trademark of Boston Scientific.
89% of patients
in a study* had
a reduction in
menstrual pain
and cramping 6
60
Percentage of Patients
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
In a study,
99% would
recommend the
procedure to
other women 6
With NovaSure®, “Patients with a uterine cavity length greater than
6.0 cm had observed success rates that were lower than overall
study success rates.” 3
GYNECARE THERMACHOICE ® III Provides Deeper Tissue Necrosis8
50
0.28 mm
deeper
6
40
None
Mild
Moderate
Severe
30
20
10
0.95 mm
deeper
4
GYNECARE
THERMACHOICE® I
mm
• Effective treatment without
GYNECARE
THERMACHOICE® II
2
GYNECARE
THERMACHOICE® III
0
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
UBT
RB
Baseline
UBT
RB
3-Year Follow-up
UBT
RB
5-Year Follow-up
0
Cornua
Mid-body
Fundus
Location
Mean Depth of Necrosis by Location
(Anterior and Posterior Pooled; Location Averaged)
GYNECARE THERMACHOICE
®
The longest safety record on the market.
REFERENCES: 1. Data on file, ETHICON, Inc. 2. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of
uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):429-435. 3. NovaSure.
Instructions for use. © 2004, Cytyc Corporation. 4. Summary of Safety & Effectiveness Data: GYNECARE THERMACHOICE Uterine Balloon
Therapy System. PMA 970021. 1997. 5. Summary of Safety & Effectiveness Data: CryoGen Her Option Uterine Cryoablation Therapy System.
PMA P000032, version 8.0. September 14, 2002. 6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc. 7. Hydro
ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation. 8. Extirpated uteri data on file, ETHICON, Inc. 9. Her Option.
Instructions for use. © 2006 American Medical Systems, Inc. 10. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety
and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428. 11. Loffer FD. Three-year
comparison of thermal balloon and rollerball ablation in treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8(1):48-54.
Make GYNECARE THERMACHOICE III Your Choice
®
Make GYNECARE THERMACHOICE ® III Your Choice
…for effective treatment of
your patients
…for an effective solution to
stop heavy bleeding
Ordering Information
The Evolution of
GYNECARE
THERMACHOICE®
Patient Report
Comparisons*
TODAY
GYNECARE THERMACHOICE III
®
has a conforming balloon which
GYNECARE
THERMACHOICE® III6
NovaSure
Patients returning
to normal levels of
menstrual bleeding
or lower
81%
78%
Patients experiencing
amenorrhea at
12 months
37%
Patients reporting
satisfaction
96%
Patients experiencing
reduction in
dysmenorrhea
89%
®3
Her Option
HTA®
System7
67%
68%
36%
®9
22%
35%
leads to improved coverage,
treatment and efficacy 8
1999
92%
86%
88%
N/A
is introduced, providing a
silicone balloon material and
fluid circulation
Percent of Evaluable Patients Returning to
Normal Levels of Menstrual Bleeding or Lower
94% of patients
1997
treated with GYNECARE
THERMACHOICE ® III 2
GYNECARE THERMACHOICE ® I
GYNECARE THERMACHOICE
Uterine Balloon Therapy Catheter
Sterile, single use catheters
TC003..............................................................Box of 5
TC013..............................................................Single pack
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
89% of patients in a
63%
91% of patients
vs.
treated with NovaSure®10
study* had a reduction
in menstrual pain
and cramping 6
9 out of 10 women
avoided hysterectomy
at 3 years11
In a study,
99% would
recommend the
procedure to
other women 6
the first GEA device,
is introduced
Description
®
N/A
*Based on Intent-To-Treat population
3. NovaSure. Instructions for use. © 2004, Cytyc Corporation.
6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc.
7. Hydro ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation.
9. Her Option. Instructions for use. © 2006 American Medical Systems, Inc.
N/A=not available
GYNECARE THERMACHOICE ® II
Product Code
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
A division of ETHICON, INC.
a Johnson & Johnson company
© ETHICON, INC. 2008
TC138 • 10/08
GYNECARE THERMACHOICE ®
Uterine Balloon Therapy System
00825 ..............................................................Controller
01105 ..............................................................Umbilical Cord
04995 ..............................................................Power Cord
CPT Code Information
Code Number
Description
58563 ................Endometrial ablation with hysteroscopy
58353 ................Endometrial ablation without hysteroscopy
64435 ................Injection, anesthetic agent; paracervical
(uterine) nerve
For reimbursement support,
please call the ETHICON
Reimbursement Hotline at
1-800-964-8496.
If offering in the office, ensure utilization of Site of Service Code 11.
GYNECARE THERMACHOICE® Uterine Balloon Therapy System
Essential Product Information
INDICATIONS: The GYNECARE THERMACHOICE® UBT System is a thermal balloon ablation device intended to ablate the
endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes
for whom childbearing is complete. CONTRAINDICATIONS: The device is contraindicated for use in a patient: who is pregnant
or who wants to become pregnant in the future; with known or suspected endometrial carcinoma (uterine cancer) or premalignant
change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which
weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy;
with active genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis);
with an intrauterine device (IUD) currently in place. ADVERSE EVENTS include: rupture of the uterus; thermal injury to adjacent
tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical
burn; hemorrhage; infection or sepsis; perforation; post-ablation-tubal sterilization syndrome; complications leading to serious
injury or death; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the
fetus); vesico-uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with
hysteroscopy. WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious
patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur
if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal
ligation are at increased risk of developing post-ablation-tubal sterilization syndrome which can require hysterectomy.
Endometrial ablation procedures using the GYNECARE THERMACHOICE® UBT System should be performed only by medical
professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and
curettage (D&C), and who have adequate training and familiarity with GYNECARE THERMACHOICE® UBT System.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® UBT System. Refer to package insert
for complete product information including warnings, precautions, and adverse reactions. RX Only.
THE INFORMATION CONTAINED IN THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENTS NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon
Women's Health & Urology CONCERNING LEVELS OF REIMBURSEMENT, PAYMENT, OR CHARGE.
SIMILARLY, ALL CPT (COPYRIGHT AMA) AND HCPCS CODES ARE SUPPLIED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENT NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon Women's
Health and Urology THAT THESE CODES WILL BE APPROPRIATE OR THAT REIMBURSEMENT
WILL BE MADE. IT IS NOT INTENDED TO INCREASE OR MAXIMIZE REIMBURSEMENT BY ANY
PAYOR. WE STRONGLY RECOMMEND THAT YOU CONSULT YOUR PAYOR ORGANIZATION WITH
REGARD TO ITS REIMBURSEMENT POLICIES.
…for customized coverage.
…to help end heavy periods.
Make GYNECARE THERMACHOICE ® III Your Choice
…designed for safe treatment
…for lasting pain reduction
over time
…for more complete coverage
2
• Conforms to most uterine shapes and sizes with no reduction of efficacy
• Can be done under local anesthesia
Conforms to Most Uterine Shapes and Sizes
With No Reduction of Efficacy
Dysmenorrhea and Menorrhagia May Go Hand-in-Hand
• Requires minimal, if any, dilation
In clinical trials of the leading global endometrial ablation systems, data suggest
that dysmenorrhea and menorrhagia co-exist in up to 93% of patients with
documented menorrhagia at study enrollment.3,4,5
• Safety mechanisms are built in throughout the procedure to minimize
the occurrence of harmful incidents
• Fluid is contained in flexible and non-allergenic material
GYNECARE THERMACHOICE ® Effectively Decreased
Long-term Dysmenorrhea2
– hormones
– radio frequency
– the need for IV sedation
Her Option®
NovaSure®
& HTA®
• Over 30% reported only mild pain associated with menses
Microsulis
Fewer Patients Experienced Menstrual Pain at 3 and 5 Years2
5 mm
6 mm
8 mm
• 26% less untreated corneal tissue
• Improved coverage of the lower uterine segment
• Over 50% reported no pain associated with menses
GYNECARE
THERMACHOICE®
• More even necrosis of tissue throughout the entire endometrium
After five years:
Smaller dilation compared to 3 leading brands
Uterine Balloon Therapy System
Based on ex vivo Studies7 vs. the Previous Balloon
At one-year and three-year follow-up, nearly 3 out of 4 women surveyed
who were treated with GYNECARE THERMACHOICE ® reported reductions
in dysmenorrhea.2
9 mm
Her Option® is a registered trademark of American Medical Systems.
NovaSure® is a registered trademark of Cytyc Corporation.
HTA® System is a registered trademark of Boston Scientific.
89% of patients
in a study* had
a reduction in
menstrual pain
and cramping 6
60
Percentage of Patients
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
In a study,
99% would
recommend the
procedure to
other women 6
With NovaSure®, “Patients with a uterine cavity length greater than
6.0 cm had observed success rates that were lower than overall
study success rates.” 3
GYNECARE THERMACHOICE ® III Provides Deeper Tissue Necrosis8
50
0.28 mm
deeper
6
40
None
Mild
Moderate
Severe
30
20
10
0.95 mm
deeper
4
GYNECARE
THERMACHOICE® I
mm
• Effective treatment without
GYNECARE
THERMACHOICE® II
2
GYNECARE
THERMACHOICE® III
0
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
UBT
RB
Baseline
UBT
RB
3-Year Follow-up
UBT
RB
5-Year Follow-up
0
Cornua
Mid-body
Fundus
Location
Mean Depth of Necrosis by Location
(Anterior and Posterior Pooled; Location Averaged)
GYNECARE THERMACHOICE
®
The longest safety record on the market.
REFERENCES: 1. Data on file, ETHICON, Inc. 2. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of
uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):429-435. 3. NovaSure.
Instructions for use. © 2004, Cytyc Corporation. 4. Summary of Safety & Effectiveness Data: GYNECARE THERMACHOICE Uterine Balloon
Therapy System. PMA 970021. 1997. 5. Summary of Safety & Effectiveness Data: CryoGen Her Option Uterine Cryoablation Therapy System.
PMA P000032, version 8.0. September 14, 2002. 6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc. 7. Hydro
ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation. 8. Extirpated uteri data on file, ETHICON, Inc. 9. Her Option.
Instructions for use. © 2006 American Medical Systems, Inc. 10. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety
and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428. 11. Loffer FD. Three-year
comparison of thermal balloon and rollerball ablation in treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8(1):48-54.
Make GYNECARE THERMACHOICE ® III Your Choice
…designed for safe treatment
…for lasting pain reduction
over time
…for more complete coverage
2
• Conforms to most uterine shapes and sizes with no reduction of efficacy
• Can be done under local anesthesia
Conforms to Most Uterine Shapes and Sizes
With No Reduction of Efficacy
Dysmenorrhea and Menorrhagia May Go Hand-in-Hand
• Requires minimal, if any, dilation
In clinical trials of the leading global endometrial ablation systems, data suggest
that dysmenorrhea and menorrhagia co-exist in up to 93% of patients with
documented menorrhagia at study enrollment.3,4,5
• Safety mechanisms are built in throughout the procedure to minimize
the occurrence of harmful incidents
• Fluid is contained in flexible and non-allergenic material
GYNECARE THERMACHOICE ® Effectively Decreased
Long-term Dysmenorrhea2
– hormones
– radio frequency
– the need for IV sedation
Her Option®
NovaSure®
& HTA®
• Over 30% reported only mild pain associated with menses
Microsulis
Fewer Patients Experienced Menstrual Pain at 3 and 5 Years2
5 mm
6 mm
8 mm
• 26% less untreated corneal tissue
• Improved coverage of the lower uterine segment
• Over 50% reported no pain associated with menses
GYNECARE
THERMACHOICE®
• More even necrosis of tissue throughout the entire endometrium
After five years:
Smaller dilation compared to 3 leading brands
Uterine Balloon Therapy System
Based on ex vivo Studies7 vs. the Previous Balloon
At one-year and three-year follow-up, nearly 3 out of 4 women surveyed
who were treated with GYNECARE THERMACHOICE ® reported reductions
in dysmenorrhea.2
9 mm
Her Option® is a registered trademark of American Medical Systems.
NovaSure® is a registered trademark of Cytyc Corporation.
HTA® System is a registered trademark of Boston Scientific.
89% of patients
in a study* had
a reduction in
menstrual pain
and cramping 6
60
Percentage of Patients
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
In a study,
99% would
recommend the
procedure to
other women 6
With NovaSure®, “Patients with a uterine cavity length greater than
6.0 cm had observed success rates that were lower than overall
study success rates.” 3
GYNECARE THERMACHOICE ® III Provides Deeper Tissue Necrosis8
50
0.28 mm
deeper
6
40
None
Mild
Moderate
Severe
30
20
10
0.95 mm
deeper
4
GYNECARE
THERMACHOICE® I
mm
• Effective treatment without
GYNECARE
THERMACHOICE® II
2
GYNECARE
THERMACHOICE® III
0
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
UBT
RB
Baseline
UBT
RB
3-Year Follow-up
UBT
RB
5-Year Follow-up
0
Cornua
Mid-body
Fundus
Location
Mean Depth of Necrosis by Location
(Anterior and Posterior Pooled; Location Averaged)
GYNECARE THERMACHOICE
®
The longest safety record on the market.
REFERENCES: 1. Data on file, ETHICON, Inc. 2. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of
uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):429-435. 3. NovaSure.
Instructions for use. © 2004, Cytyc Corporation. 4. Summary of Safety & Effectiveness Data: GYNECARE THERMACHOICE Uterine Balloon
Therapy System. PMA 970021. 1997. 5. Summary of Safety & Effectiveness Data: CryoGen Her Option Uterine Cryoablation Therapy System.
PMA P000032, version 8.0. September 14, 2002. 6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc. 7. Hydro
ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation. 8. Extirpated uteri data on file, ETHICON, Inc. 9. Her Option.
Instructions for use. © 2006 American Medical Systems, Inc. 10. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety
and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428. 11. Loffer FD. Three-year
comparison of thermal balloon and rollerball ablation in treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8(1):48-54.
Make GYNECARE THERMACHOICE ® III Your Choice
…designed for safe treatment
…for lasting pain reduction
over time
…for more complete coverage
2
• Conforms to most uterine shapes and sizes with no reduction of efficacy
• Can be done under local anesthesia
Conforms to Most Uterine Shapes and Sizes
With No Reduction of Efficacy
Dysmenorrhea and Menorrhagia May Go Hand-in-Hand
• Requires minimal, if any, dilation
In clinical trials of the leading global endometrial ablation systems, data suggest
that dysmenorrhea and menorrhagia co-exist in up to 93% of patients with
documented menorrhagia at study enrollment.3,4,5
• Safety mechanisms are built in throughout the procedure to minimize
the occurrence of harmful incidents
• Fluid is contained in flexible and non-allergenic material
GYNECARE THERMACHOICE ® Effectively Decreased
Long-term Dysmenorrhea2
– hormones
– radio frequency
– the need for IV sedation
Her Option®
NovaSure®
& HTA®
• Over 30% reported only mild pain associated with menses
Microsulis
Fewer Patients Experienced Menstrual Pain at 3 and 5 Years2
5 mm
6 mm
8 mm
• 26% less untreated corneal tissue
• Improved coverage of the lower uterine segment
• Over 50% reported no pain associated with menses
GYNECARE
THERMACHOICE®
• More even necrosis of tissue throughout the entire endometrium
After five years:
Smaller dilation compared to 3 leading brands
Uterine Balloon Therapy System
Based on ex vivo Studies7 vs. the Previous Balloon
At one-year and three-year follow-up, nearly 3 out of 4 women surveyed
who were treated with GYNECARE THERMACHOICE ® reported reductions
in dysmenorrhea.2
9 mm
Her Option® is a registered trademark of American Medical Systems.
NovaSure® is a registered trademark of Cytyc Corporation.
HTA® System is a registered trademark of Boston Scientific.
89% of patients
in a study* had
a reduction in
menstrual pain
and cramping 6
60
Percentage of Patients
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
In a study,
99% would
recommend the
procedure to
other women 6
With NovaSure®, “Patients with a uterine cavity length greater than
6.0 cm had observed success rates that were lower than overall
study success rates.” 3
GYNECARE THERMACHOICE ® III Provides Deeper Tissue Necrosis8
50
0.28 mm
deeper
6
40
None
Mild
Moderate
Severe
30
20
10
0.95 mm
deeper
4
GYNECARE
THERMACHOICE® I
mm
• Effective treatment without
GYNECARE
THERMACHOICE® II
2
GYNECARE
THERMACHOICE® III
0
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
UBT
RB
Baseline
UBT
RB
3-Year Follow-up
UBT
RB
5-Year Follow-up
0
Cornua
Mid-body
Fundus
Location
Mean Depth of Necrosis by Location
(Anterior and Posterior Pooled; Location Averaged)
GYNECARE THERMACHOICE
®
The longest safety record on the market.
REFERENCES: 1. Data on file, ETHICON, Inc. 2. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of
uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9(4):429-435. 3. NovaSure.
Instructions for use. © 2004, Cytyc Corporation. 4. Summary of Safety & Effectiveness Data: GYNECARE THERMACHOICE Uterine Balloon
Therapy System. PMA 970021. 1997. 5. Summary of Safety & Effectiveness Data: CryoGen Her Option Uterine Cryoablation Therapy System.
PMA P000032, version 8.0. September 14, 2002. 6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc. 7. Hydro
ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation. 8. Extirpated uteri data on file, ETHICON, Inc. 9. Her Option.
Instructions for use. © 2006 American Medical Systems, Inc. 10. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safety
and efficacy of the NovaSure system in the treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2002;9:418-428. 11. Loffer FD. Three-year
comparison of thermal balloon and rollerball ablation in treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001;8(1):48-54.
Make GYNECARE THERMACHOICE III Your Choice
®
Make GYNECARE THERMACHOICE ® III Your Choice
…for effective treatment of
your patients
…for an effective solution to
stop heavy bleeding
Ordering Information
The Evolution of
GYNECARE
THERMACHOICE®
Patient Report
Comparisons*
TODAY
GYNECARE THERMACHOICE III
®
has a conforming balloon which
GYNECARE
THERMACHOICE® III6
NovaSure
Patients returning
to normal levels of
menstrual bleeding
or lower
81%
78%
Patients experiencing
amenorrhea at
12 months
37%
Patients reporting
satisfaction
96%
Patients experiencing
reduction in
dysmenorrhea
89%
®3
Her Option
HTA®
System7
67%
68%
36%
®9
22%
35%
leads to improved coverage,
treatment and efficacy 8
1999
92%
86%
88%
N/A
is introduced, providing a
silicone balloon material and
fluid circulation
Percent of Evaluable Patients Returning to
Normal Levels of Menstrual Bleeding or Lower
94% of patients
1997
treated with GYNECARE
THERMACHOICE ® III 2
GYNECARE THERMACHOICE ® I
GYNECARE THERMACHOICE
Uterine Balloon Therapy Catheter
Sterile, single use catheters
TC003..............................................................Box of 5
TC013..............................................................Single pack
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
89% of patients in a
63%
91% of patients
vs.
treated with NovaSure®10
study* had a reduction
in menstrual pain
and cramping 6
9 out of 10 women
avoided hysterectomy
at 3 years11
In a study,
99% would
recommend the
procedure to
other women 6
the first GEA device,
is introduced
Description
®
N/A
*Based on Intent-To-Treat population
3. NovaSure. Instructions for use. © 2004, Cytyc Corporation.
6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc.
7. Hydro ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation.
9. Her Option. Instructions for use. © 2006 American Medical Systems, Inc.
N/A=not available
GYNECARE THERMACHOICE ® II
Product Code
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
A division of ETHICON, INC.
a Johnson & Johnson company
© ETHICON, INC. 2008
TC138 • 10/08
GYNECARE THERMACHOICE ®
Uterine Balloon Therapy System
00825 ..............................................................Controller
01105 ..............................................................Umbilical Cord
04995 ..............................................................Power Cord
CPT Code Information
Code Number
Description
58563 ................Endometrial ablation with hysteroscopy
58353 ................Endometrial ablation without hysteroscopy
64435 ................Injection, anesthetic agent; paracervical
(uterine) nerve
For reimbursement support,
please call the ETHICON
Reimbursement Hotline at
1-800-964-8496.
If offering in the office, ensure utilization of Site of Service Code 11.
GYNECARE THERMACHOICE® Uterine Balloon Therapy System
Essential Product Information
INDICATIONS: The GYNECARE THERMACHOICE® UBT System is a thermal balloon ablation device intended to ablate the
endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes
for whom childbearing is complete. CONTRAINDICATIONS: The device is contraindicated for use in a patient: who is pregnant
or who wants to become pregnant in the future; with known or suspected endometrial carcinoma (uterine cancer) or premalignant
change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which
weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy;
with active genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis);
with an intrauterine device (IUD) currently in place. ADVERSE EVENTS include: rupture of the uterus; thermal injury to adjacent
tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical
burn; hemorrhage; infection or sepsis; perforation; post-ablation-tubal sterilization syndrome; complications leading to serious
injury or death; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the
fetus); vesico-uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with
hysteroscopy. WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious
patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur
if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal
ligation are at increased risk of developing post-ablation-tubal sterilization syndrome which can require hysterectomy.
Endometrial ablation procedures using the GYNECARE THERMACHOICE® UBT System should be performed only by medical
professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and
curettage (D&C), and who have adequate training and familiarity with GYNECARE THERMACHOICE® UBT System.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® UBT System. Refer to package insert
for complete product information including warnings, precautions, and adverse reactions. RX Only.
THE INFORMATION CONTAINED IN THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENTS NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon
Women's Health & Urology CONCERNING LEVELS OF REIMBURSEMENT, PAYMENT, OR CHARGE.
SIMILARLY, ALL CPT (COPYRIGHT AMA) AND HCPCS CODES ARE SUPPLIED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENT NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon Women's
Health and Urology THAT THESE CODES WILL BE APPROPRIATE OR THAT REIMBURSEMENT
WILL BE MADE. IT IS NOT INTENDED TO INCREASE OR MAXIMIZE REIMBURSEMENT BY ANY
PAYOR. WE STRONGLY RECOMMEND THAT YOU CONSULT YOUR PAYOR ORGANIZATION WITH
REGARD TO ITS REIMBURSEMENT POLICIES.
…for customized coverage.
…to help end heavy periods.
Make GYNECARE THERMACHOICE III Your Choice
®
Make GYNECARE THERMACHOICE ® III Your Choice
…for effective treatment of
your patients
…for an effective solution to
stop heavy bleeding
Ordering Information
The Evolution of
GYNECARE
THERMACHOICE®
Patient Report
Comparisons*
TODAY
GYNECARE THERMACHOICE III
®
has a conforming balloon which
GYNECARE
THERMACHOICE® III6
NovaSure
Patients returning
to normal levels of
menstrual bleeding
or lower
81%
78%
Patients experiencing
amenorrhea at
12 months
37%
Patients reporting
satisfaction
96%
Patients experiencing
reduction in
dysmenorrhea
89%
®3
Her Option
HTA®
System7
67%
68%
36%
®9
22%
35%
leads to improved coverage,
treatment and efficacy 8
1999
92%
86%
88%
N/A
is introduced, providing a
silicone balloon material and
fluid circulation
Percent of Evaluable Patients Returning to
Normal Levels of Menstrual Bleeding or Lower
94% of patients
1997
treated with GYNECARE
THERMACHOICE ® III 2
GYNECARE THERMACHOICE ® I
GYNECARE THERMACHOICE
Uterine Balloon Therapy Catheter
Sterile, single use catheters
TC003..............................................................Box of 5
TC013..............................................................Single pack
In a study, 96%
of patients reported
satisfaction with
GYNECARE
THERMACHOICE ® III 1
89% of patients in a
63%
91% of patients
vs.
treated with NovaSure®10
study* had a reduction
in menstrual pain
and cramping 6
9 out of 10 women
avoided hysterectomy
at 3 years11
In a study,
99% would
recommend the
procedure to
other women 6
the first GEA device,
is introduced
Description
®
N/A
*Based on Intent-To-Treat population
3. NovaSure. Instructions for use. © 2004, Cytyc Corporation.
6. GYNECARE THERMACHOICE III. Instructions for use. © 2008 ETHICON, Inc.
7. Hydro ThermAblator® System. Instructions for use. © 2005 Boston Scientific Corporation.
9. Her Option. Instructions for use. © 2006 American Medical Systems, Inc.
N/A=not available
GYNECARE THERMACHOICE ® II
Product Code
*Outcomes based on a combination of
GYNECARE THERMACHOICE ® I and
GYNECARE THERMACHOICE ® II data
A division of ETHICON, INC.
a Johnson & Johnson company
© ETHICON, INC. 2008
TC138 • 10/08
GYNECARE THERMACHOICE ®
Uterine Balloon Therapy System
00825 ..............................................................Controller
01105 ..............................................................Umbilical Cord
04995 ..............................................................Power Cord
CPT Code Information
Code Number
Description
58563 ................Endometrial ablation with hysteroscopy
58353 ................Endometrial ablation without hysteroscopy
64435 ................Injection, anesthetic agent; paracervical
(uterine) nerve
For reimbursement support,
please call the ETHICON
Reimbursement Hotline at
1-800-964-8496.
If offering in the office, ensure utilization of Site of Service Code 11.
GYNECARE THERMACHOICE® Uterine Balloon Therapy System
Essential Product Information
INDICATIONS: The GYNECARE THERMACHOICE® UBT System is a thermal balloon ablation device intended to ablate the
endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes
for whom childbearing is complete. CONTRAINDICATIONS: The device is contraindicated for use in a patient: who is pregnant
or who wants to become pregnant in the future; with known or suspected endometrial carcinoma (uterine cancer) or premalignant
change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which
weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy;
with active genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis);
with an intrauterine device (IUD) currently in place. ADVERSE EVENTS include: rupture of the uterus; thermal injury to adjacent
tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical
burn; hemorrhage; infection or sepsis; perforation; post-ablation-tubal sterilization syndrome; complications leading to serious
injury or death; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the
fetus); vesico-uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with
hysteroscopy. WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious
patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur
if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal
ligation are at increased risk of developing post-ablation-tubal sterilization syndrome which can require hysterectomy.
Endometrial ablation procedures using the GYNECARE THERMACHOICE® UBT System should be performed only by medical
professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and
curettage (D&C), and who have adequate training and familiarity with GYNECARE THERMACHOICE® UBT System.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® UBT System. Refer to package insert
for complete product information including warnings, precautions, and adverse reactions. RX Only.
THE INFORMATION CONTAINED IN THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENTS NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon
Women's Health & Urology CONCERNING LEVELS OF REIMBURSEMENT, PAYMENT, OR CHARGE.
SIMILARLY, ALL CPT (COPYRIGHT AMA) AND HCPCS CODES ARE SUPPLIED FOR INFORMATIONAL
PURPOSES ONLY AND REPRESENT NO STATEMENT, PROMISE, OR GUARANTEE BY Ethicon Women's
Health and Urology THAT THESE CODES WILL BE APPROPRIATE OR THAT REIMBURSEMENT
WILL BE MADE. IT IS NOT INTENDED TO INCREASE OR MAXIMIZE REIMBURSEMENT BY ANY
PAYOR. WE STRONGLY RECOMMEND THAT YOU CONSULT YOUR PAYOR ORGANIZATION WITH
REGARD TO ITS REIMBURSEMENT POLICIES.
…for customized coverage.
…to help end heavy periods.