over 10 years of data and 2 million patients treated. A

Proven
over 10 years of data and
2 million patients treated.
A Complete Guide to NovaSure Endometrial Ablation
This is a general information tool for medical professionals and is not a complete representation of the product(s)’ Instructions
for Use (IFU) or Package Insert, and it is the medical professionals’ responsibility to read and follow the IFU or Package Insert.
The information provided may suggest a particular technique or protocol; however, it is the sole responsibility of the medical
professional to determine which technique or protocol is appropriate. At all times clinicians remain responsible for utilizing sound
patient evaluation and selection practices, and for complying with applicable local, state and federal rules and regulations
regarding accreditation, anesthesia, reimbursement and all other aspects of in-office procedures. In no event shall Hologic be
liable for damages of any kind resulting from your use of the information presented.
Efficacy
❶
Efficacy
Efficacy
The power of performance
The NovaSure procedure has proven efficacy when compared to other GEA devices, with the highest amenorrhea
and highest patient satisfaction and the lowest re-intervention rates in direct head-to-head trials.
NovaSure amenorrhea rates
NovaSure successful reduction in bleeding
100
100
Kalkat
Busund 2
80
Gallinat
Baskett 4
Fulop 5
95%
91%
1
100%
98%
95%
Amenorrhea
Bleeding reduction
to normal levels
80
3
60
75%
69%
60
56%
55%
40
40
20
20
0
41%
0
6 Months
1 Year
3 Years
5 Years
The NovaSure endometrial ablation procedure
has demonstrated exceptional amenorrhea rates
in multiple clinical studies for over 10 years.
7 Years
Cooper et al.
2002 6
Bertrand
2005 7
Sabbah et al.
2006 8
Gallinat
2007 3
Clark
2010 9
The same studies showing excellent amenorrhea rates also demonstrate
high efficacy in improvement to normal bleeding levels or better.
Re-intervention rate comparison
Five prospective studies demonstrate a single-digit re-intervention rate with the NovaSure procedure.
No other global endometrial ablation (GEA) modality comes close.
NovaSure surgical re-intervention rates
NovaSure re-intervention vs. HTA
NovaSure re-intervention
vs. ThermaChoice
10
9
10
8%
30%
10
10
30%
30%
8%
8%
7.7%
24%
7.7%
24%
24%
7.7%
20%
20%
20%
5
4%
5
5
4%
4%
10%
10%
10%
2.4%
6%
6%
6%
0
0
6 Months
1 Year
0
Busund2
Baskett4
3 Years
0
0
Months
16Year
3
Gallinat
6 Months
NovaSure
HTA™
1 Year
3 Years
3 Years
Busund32
Gallinat
Baskett24
Busund
Baskett4
2.4%
2.4%
NovaSure
0
0
NovaSure
NovaSure
HTA™
ThermaChoice™
0
HTA™
0
NovaSure
NovaSure ™ ThermaChoice™
ThermaChoice
Gallinat3
The NovaSure procedure has been shown to improve both PMS and menstrual pain.
Statistically significant improvement in PMS and menstrual pain after the NovaSure procedure
11
PMS
PMS
Menstrual Pain
Before
Before
Before
Before
0
4
4
8
8
After
After
After
After
0
Menstrual Pain
0
0
4
(Self-rating of PMS symptoms on a scale of 0 (none) to 10 (severe))
4
8
8
Our Technology
❷ Our Technology
Our Technology
A customized ablation
The NovaSure device provides a customized ablation during every procedure.
The procedure’s proven outcomes are achieved through:
1
i-polar RF energy
B
• Four uniquely designed electrodes that form
the array deliver the energy.
• Array shape is designed to deliver the proper
depth of energy.
• Ablation profile is designed to be tapered
to the uterine cavity.
2
A proactive cavity integrity assessment
• This ensures that the cavity can hold 50 mmHg
to check for a perforation.
•Assessment is sensitive enough to detect
a perforation as small as an 18-gauge needle.
3
he moisture transport system
T
• Vacuum draws uterine cavities into
contact with the array, even those
that are imperfectly shaped.
• Removes steam, moisture and other
by-products of the ablation.
4
The scientific endpoint
• 50 ohms of impedance determines when ablation
is complete.
• 90-second average treatment time; ablation is never
more than 2 minutes.
“I have many patients that come back and tell me, I wish
I’d done this years ago because my life is so much better.
The benefits are plentiful. I have many, many hundreds of
patients that tell me these things.”
Dr. Darren Housel, M.D.
Physician, Circle of Life Women’s Center,
Ogden, UT
The NovaSure system delivers comfort, control, and confidence.
Smooth Access tips
require significantly less
manipulation, providing more
comfort for your patient.
SureFit cervical seal
is designed from soft material
providing a 70% greater coverage
area, improving procedure
efficiency and patient comfort.
Sheath material
designed to promote
greater durability, especially
at higher temperatures.
Customized ablation
is designed to deliver optimal
results based on the patient’s
uterine cavity length and width.
™
™
Ergonomic thumb tab
enables more leverage and
control of the cervical collar.
No uterine distention
Patented Moisture Transport System
maintains contact between the uterus and
the array while evacuating by-products
of the procedure.
Proactive safety
CIA Test evaluates
uterine cavity integrity
prior to procedure.
NovaSure RFC10 controller
The newly designed RFC10 controller has been enhanced with intuitive graphics for improved workflow.
Advanced
touchscreen interface
has responsiveness set to
react to user intent and
is optimized for use with or
without surgical gloves.
Ablation timer and
summary screen
display cumulative running
ablation time and total ablation
time at the end of the procedure,
as well as length, width and
power level. The prior procedure
data is also recoverable if the
controller is powered off and on.
IFU Procedural
instructions on interface
walks the physician through
corrective actions when an
error message is encountered.
Volume-controlled
and mutable alarms
are perfect for in-office
procedures during which a
patient can be easily startled.
Universal NovaSure
compatibility
with all generations
of NovaSure devices.
SureSound uterine cavity measuring device
®
The SureSound device is a single use, uterine and cervical canal length measurement device consisting
of an external shaft and an internal, polyethylene telescoping sound controlled by a locking deployment tab.
1/2 cm markings
are easy to read and
increase measurement
accuracy.
Shoulder and internal
lumen design
allow for consistent measurement
from internal cervical os to the
fundus by eliminating the need
to measure the cervical canal.
SureSound single-use device
may reduce contamination risk
compared to traditional sound.
Note: Does not contain latex material in the construction or components of the device.
“I’ve done hundreds of NovaSure ablation procedures
and I see these patients back for their annual visits
and checkups. These are among the happiest
patients that we see.”
Dr. Robert Stevens, M.D.
Seven Hills Women’s Health Center
Medical Director, Women’s Healthcare Service Line:
The Christ Hospital, Cincinnati OH
Patient Satisfaction
❸
Patient Satisfaction
Patient Satisfaction
The NovaSure procedure as a first-line treatment option
Over 8.3 million women suffer from excessive menstrual bleeding, yet only 13% seek treatment each year.
77% of patients want to hear about the NovaSure procedure at their first visit.
13
12
Impact on Quality of Life
Before
NovaSure
After
NovaSure
Do you lack confidence due to your period?
57%
16%
Do you have a problem working due to your period?
66%
10%
Do you spend less time at work or other activities?
61%
9%
Do you feel anxious due to your period?
75%
24%
Do your periods cause you to miss social activities?
63%
9%
Do your periods cause you to miss athletic activities?
66%
9%
Are you unable to work outside your home due to your periods?
33%
6%
Do you have less energy or a total lack of energy?
84%
24%
Do you experience painful periods?
57%
21%
Do you have PMS symptoms?
65%
36%
Answered “Always,” “Frequently” or “Sometimes”
The NovaSure procedure significantly reduces
debilitating menorrhagia symptoms.
rior to NovaSure treatment, most women complained
P
of problems associated with heavy menses, including:
• Anxiety.
The NovaSure procedure improves patient quality of life.
In a clinical trial:
of evaluable patients returned to normal levels
%
of menstrual bleeding, or lower.
91
6
patient satisfaction.
93
%
• Lack of confidence.
• Difficulty with work or daily activities.
16
of patients from the initial clinical trial would recommend
%
the NovaSure procedure to other women.
97
• Lack of energy.
16
of patients from the initial clinical trial experienced no
%
post-procedural pain.
97
Celebrating over two million women treated
Improvements in symptoms
16
100
84%
80
Pretreatment
75%
66%
60
12 month follow-up
57%
40
20
24%
24%
16%
10%
0
Anxiety
Lack of
confidence
16
Difficulty with
work/activities
Lack of
energy
GEA Technologies
❹ GEA Technologies
GEA Technologies
The NovaSure procedure offers clear advantages for proven outcomes.
NovaSure
16
ThermaChoice III
®17
HTA
®18
HerOption
®19
Average treatment time
90 seconds
8 minutes
10 minutes
10-34 minutes
Average procedure time
4.2 minutes
27.4 minutes
26.4 minutes
N/A
No pretreatment required
R
R
S
S
S
S
S
S
Not cycle dependent
“The NovaSure procedure being done in the office is
advantageous to not only the patient, but also to the
physician and to the practice as a whole.”
Dr. Stephen Brown, M.D., F.A.C.O.G
President, CNY Women’s Healthcare, Syracuse, NY
Competitive analysis
The NovaSure procedure is the most proven GEA modality in head-to-head trials.
20
The NovaSure procedure has the highest amenorrhea
rates in direct head-to-head trials of endometrial
ablation modalities.
NovaSure re-intervention
vs. HTA
Amenorrhea rates
50
*
Amenorrhea rate (%)
NovaSure
ThermalChoice
*
56%
30%
9
8%
30%
8%
HTA
7.7%
*
47%
*
43%
43%
NovaSure re-intervention
vs. ThermaChoice
10
*
56%
60
The NovaSure procedure also has the lowest re-intervention
rates in direct head-to-head studies with other global endometrial
ablation modalities.
24%
40
20%
7.7%
24%
20%
30
4%
24%
23%
4%
20
10%
11%
10%
8%
10
6%
0
Abbott, 200321
Bongers, 200422**
NovaSure vs. ThermaChoice
Clark, 20119
2.4%
6%
2.4%
Penninx, 201010
NovaSure vs. HTA
0
0
NovaSure NovaSure
HTA
0
HTA
0
NovaSure NovaSure
ThermaChoice
ThermaChoice
Medical Management
❺
Medical Management
Medical Management
Clinical data review
NovaSure
LNG-IUS
NovaSure
NovaSure
100
80
60
91%3
80
95%6
91%3
95%6
Cooper,, Coo
Cooper
Cooper
per,,
2002
200
2 200
002
2
Cooper
Coo
per,,
200
002
2
Gallin
Ga
linat,
at,
Gal
2007
200
7
0
97%3
Gallinat,
Gallin
Ga
at,
2007
200
7
40
41%
20
97%3
60
Cooper,,
Cooper
2002
200
2
40
LNG-IUS
LNG-IUS
100
20
6
Cooper
Cooper
er,,
2002
200
2
41%
6
Cooper
Cooper
er,,
2002
200
2
0
100
80
80
60
follow-up
follow-up
60 30 67%30
67%
58%26 58%26
40
20
50%
50%
Hurskaine
Hurska
inen,
n, Hur
Hurska
skaine
inen,
n,Ewi
Ewies,
es,
2004
200
4
2004
200
4 200
2009
9
Ewies,
Ewies,
2009
200
9
50%24 50%24
40
Istre,
Ist
re,
2001
2001
0
Reduction to
Reduction to
Patient
Patient
AmenorrheaAmenorrhea
Avoidance Avoidance
1 year
Normal
Normal
SatisfactionSatisfaction1 year
of Hysterectomy
of Hysterectomy
follow-up
follow-up 5 year
vs. Rollerball vs. Rollerball
5 year
Bleeding Level
Bleeding Level
1 year follow-up
1 year follow-up
1 year follow-up
1 year follow-up
(satisfied or (satisfied or
(PBLAC ≤ 75) (PBLAC ≤ 75)
very satisfied) very satisfied)
There are
no completed
head-to-head
studies comparing
NovaSure
endometrial ablation
and LNG-IUS.
Here are the
clinical outcomes
other studies
have shown.
100
Istre,
Ist
re,
2001
2001
Ewies,
Ewi
es,
2009
200
9
20
Ewies,
Ewies,
2009
200
9
20%25 20%25
Mirena
Mir
ena
Package
Packag
e
Insert
Ins
ert
0
Mirena
Mir
ena
Package
Packag
e
Insert
Ins
ert
Reduction to
Reduction to
Patient
Patient
AmenorrheaAmenorrhea
Avoidance Avoidance
Discontinuation
Discontinuation
1 year
When InsertedWhen Inserted
Normal
Normal
SatisfactionSatisfaction1 year
of Hysterectomy
of Hysterectomy
3
follow-up
follow-up 5 year
for HMB3
year follow-up
1 year follow-up
5 year for HMB
Bleeding Level
Bleeding1Level
(satisfied)
1 year follow-up
1 year follow-up
(PBLAC ≤ 75) (PBLAC ≤ 75)
(satisfied)
follow-up
follow-up 5 year
follow-up
5 year
follow-up
Long-term outcomes of oral contraceptives
Five years following initiation of oral contraceptives, the majority of women required surgical intervention to achieve bleeding control.
27
Surgical intervention rates
100
80
77%
60
Surgical intervention
required posthormone therapy
40
Surgical intervention
required postNovaSure
20
0
77
%
of women say they would have
liked to have learned about
the NovaSure procedure
at their first consultation.
12
3%
Required treatment time to achieve outcome
NovaSure <5 minutes
6
LNG-IUS 6 months
25
The efficacy of the NovaSure procedure is immediate. LNG-IUS requires a lengthy 3-6 months to begin to control AUB.
Hysterectomy
❻ Hysterectomy
Hysterectomy
NovaSure endometrial ablation is a cost-effective, safe and simple alternative to hysterectomy.
Hysterectomy imposes a high cost
on the healthcare system.
The NovaSure procedure avoids additional intervention.
3
97% avoidance of hysterectomy at 5 years
100
$8,000
97%
80
$7,500
Ablation
Hysterectomy
60
$6,000
Avoided
hysterectomy
40
$4,000
Required
hysterectomy
$3,000
20
$2,000
0
0
Average treatment costs
3%
28
While highly effective, hysterectomy has a profound impact on patients.
Emotional and physical effects include:
- Lengthy recovery time.
- Home and work life may be limited for 4-6 weeks.
- Post-operative pain.
- Possible need for future hormone treatment due to
early onset of menopause.
- Psychological distress.
29
Surgical complications, including:
- Blood clots.
- Infection.
- Excessive bleeding.
- Damage to urinary tract.
- Bladder damage.
- Bowel damage.
- Loss of ovarian function.
29
Choosing the right treatment pathway
There are a number of treatment options available for abnormal uterine bleeding (AUB). The chart below highlights the
advantages and disadvantages of the NovaSure procedure compared to hysterectomy.
NovaSure endometrial ablation
Hysterectomy
Description
Simple, safe procedure that removes uterine lining while
preserving the uterus to reduce or eliminate bleeding
Permanent surgical option for women not responsive
to other treatments
Advantages
• For 90% of women, menstrual bleeding is dramatically
reduced or stopped
•One-time, five-minute procedure
•Can be done in your office, usually for the cost of
a copay
•Rapid recovery
•Eliminates problem bleeding
• One-time procedure
Disadvantages
•Only appropriate for women who have
completed childbearing
•Requires anesthesia: local or general
•Non-reversible - lose fertility
• Risk of complications associated with
minimally invasive procedure
•Cost
•Involves major invasive surgery
• Risk of complications associated with major surgery
• Requires general or regional anesthesia
• 2 to 8-week recovery time
• May result in early onset of menopause/possible
need for future hormone treatment
• Non-reversible – lose fertility
28
The NovaSure Procedure
❼
The NovaSure Procedure
NovaSure procedure steps and contraindications
The clear advantage for proven outcomes
The NovaSure procedure is a safe, comfortable way to provide endometrial ablation in an average of 5 minutes.
2
1
The NovaSure electrode
array expands to conform
to the contours of each
patient’s uterine cavity.
3
Cavity integrity assessment
is performed using a small
amount of CO2.
4
NovaSure endometrial
ablation delivers bipolar RF
energy until the ablation is
complete in approximately
90 seconds.
16
The electrode array is
retracted to facilitate easy
removal, leaving the uterine
lining desiccated down to
the superficial myometrium.
Indications
NovaSure is intended to ablate the endometrial lining of the uterus in premenopausal women with
menorrhagia (excessive bleeding) due to benign causes, for whom childbearing is complete.
Contraindications
NovaSure is contraindicated for use in patients who:
• Are pregnant or want to become pregnant in the future;
pregnancies following ablation can be dangerous for both
mother and fetus.
• Have known or suspected endometrial carcinoma (uterine
cancer) or pre-malignant conditions of the endometrium,
such as unresolved adenomatous hyperplasia.
• Have any anatomic condition (e.g., history of previous classical
Cesarean section or transmural myomectomy) or pathologic
condition (e.g., long-term medical therapy) that could lead to
weakening of the myometrium.
• Have an intrauterine device (IUD) currently in place.
• Have a uterine cavity length less than 4 cm (the minimum length
of the electrode array is 4 cm; treatment of a shorter uterine
cavity will result in thermal injury to the endocervical canal).
• Have a uterine cavity width less than 2.5 cm, as determined
by the width dial of the NovaSure disposable device following
device deployment.
• Have active pelvic inflammatory disease.
• Have active genital or urinary tract infection at the time of
the procedure (e.g., cervicitis, vaginitis, endometritis,
salpingitis or cystitis).
Important Safety Information:
NovaSure is for premenopausal women with heavy periods due to benign causes who are finished
childbearing. Pregnancy following NovaSure can be dangerous. NovaSure is not for those who have or
suspect uterine cancer, have an active genital, urinary or pelvic infection or an IUD. NovaSure is not a
sterilization procedure. Rare but serious risks include, but are not limited to, thermal injury, perforation and
infection. Temporary side effects may include cramping, nausea, vomiting, discharge and spotting.
hologic.com
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info@hologic.com
| +1.781.999.7300
References: 1. Kalkat RK, Cartmill RS. NovaSure Endometrial Ablation Under Local Anaesthesia in an Outpatient Setting: An Observational Study. J Obstet Gynaecol. 2011;31(2):152-155. 2. Busund B, Erno LE, Gronmark A,
Istre O. Endometrial Ablation With NovaSure GEA, A Pilot Study. Acta Obstet Gynecol Scand. Jan 2003;82(1):65-68. 3. Gallinat A. An Impedance-controlled System for Endometrial Ablation: Five-year Follow-up of 107 Patients.
J Reprod Med. Jun 2007;52(6):467-472. 4. Baskett TF, Clough H, Scott TA. NovaSure Bipolar Radiofrequency Endometrial Ablation: Report of 200 Cases. J Obstet Gynaecol Can. May 2005;27(5):473-476. 5. Fulop T, Rákóczi I,
Barna I. NovaSure impedance-controlled endometrial ablation: long-term follow-up results. J Minim Invasive Gynecol. 2007;14(1):85–90 6. Cooper J et al. J Am Assoc Gynecol Laparosc. 2002;9(4):418-28. 7. Bertrand J. J Minim
Invasive Gynecol. 2005 ;12(5):S14. 8. Sabbah R et al. J Minim Invasive Gynecol. 2006;13(5):467-71. 9. Clark TJ, Samuels N, Malick S, Middleton L, Daniels J, Gupta J. Bipolar Radiofrequency Compared With Thermal Balloon
Endometrial Ablation in the Office: A Randomized Controlled Trial. Obstet Gynecol. May 2011;117(5):1228. 10. Penninx JP, Mol BW, Engels R, et al. Bipolar Radiofrequency Endometrial Ablation Compared With Hydrothermablation
for Dysfunctional Uterine Bleeding: A Randomized Controlled Trial. Obstet Gynecol. Oct 2010;116(4):819-826. 11. Lukes AS, McBride RJ, Herring AH, Fried M, Sherwani A, Dell D. Improved premenstrual syndrome symptoms
after NovaSure endometrial ablation. J Minim Invasive Gynecol. 2011;18(5):607–611. 12. Hologic, Data On File, 2007. 13. Hologic, Data on file,2009. 14. Cooper KG, Parkin DE, Garratt AM, Grant AM. A randomized comparison
of medical and hysteroscopic management in women consulting a gynaecologist for treatment of heavy menstrual loss. Br J Obstet Gynaecol. 1997;104:1360-1366. 15. Biovid, Data (rounded to the nearest whole number) on file.
January 2005. 16. NovaSure Instructions for Use. 17. ThermaChoice III. Instructions for Use. Ethicon, Inc., 2008. 18. HydroThermAblator System. Instructions for Use. Boston Scientific Corporation, 2005. 19. Her Option. Instructions
for Use. American Medical Systems, Inc., 2006. 20. Gimpelson R, Ten-year literature review of global endometrial ablation with the NovaSure device, Int J of Women’s Health, 2014. 21. Abbott J, Hawe J, Hunter D, Garry R. A
Double-blind Randomized Trial Comparing the Cavaterm and the NovaSure Endometrial Ablation Systems for the Treatment of Dysfunctional Uterine Bleeding. Fertil Steril. Jul 2003;80(1):203-208. 22. Bongers MY, Bourdrez P, Mol
BW, Heintz AP, Brolmann HA. Randomised Controlled Trial of Bipolar Radiofrequency Endometrial Ablation and Balloon Endometrial Ablation. BJOG. Oct 2004;111(10):1095-1102. 23. Istre O, et al. Treatment of menorrhagia with
levonorgestrel intrauterine system versus endometrial resection. Fertil Steril. 2001; 76: 304-309. 24. Ewies AA. Levonorgestrel-releasing Intrauterine System - The discontinuing story. Gynecol Endo. 2009 Oct; 25(10):668-673.
25. Mirena [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2007. 26. Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system of hysterectomy
for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA 2004; 291:1456-1463. 27. Cooper K, Jack S, Parkin D, Grant A. Five-year follow-up of women randomized to medical management or transcervical resection
of the endometrium for heavy menstrual loss: Clinical and quality of life outcomes. Br J Obstet Gyneacol. 2001;108:1222-1228. 28. Wade S. Cost effectiveness of treatments for dysfunctional uterine bleeding. J Reprod Med.
2006;51:553-562. 29. MayoClinic.com Hysterectomy: Benefits and Alternatives. Available at: http://www.mayoclinic.com/invoke.cfm?id=HQ00905. Accessed October 12, 2007. 30. Istre O, et al. Treatment of menorrhagia with
levonorgestrel intrauterine system versus endometrial resection. Fertil Steril. 2001; 76: 304-309.
PB-00304-001 Rev 002 6/15 US only ©2015 Hologic, Inc. Hologic, NovaSure and SureSound are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries
in the United States and/or other countries. This information is intended for medical professionals in the U.S. and other markets and is not intended as a product solicitation
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