Hologic NovaSure User manual

NovaSure®
Instructions for Use and Controller
Operator’s Manual

Table of Contents

Physician Checklist ..................................1

System Description ..................................1

Indications .........................................3

Contraindications ...................................3

Warnings ..........................................3

Precautions ........................................4

Adverse Events .....................................5

Anticipated Post-Procedural Complications ..............6

Other Adverse Events ................................6

Clinical Study ....................................... 6

Patient Selection ..................................9

Patient Counseling ................................9

Pretreatment Preparation of Patient .....................9

NovaSure Impedance Controlled Endometrial Ablation System

Instructions for Use ................................. 10

Periodic Maintenance and Service:

Model 08-09 RF Controller ............................. 16

NovaSure Model 08-09 RF Controller LED Descriptions .....18

Troubleshooting Most Common Alarms:

Model 08-09 RF Controller ...........................18

Periodic Maintenance and Service:

Model 10 RF Controller .............................. 21

NovaSure Model 10 RF Controller Screen Icons .......... 21

Troubleshooting Most Common Alarms:

Model 10 RF Controller ............................... 22

Additional Troubleshooting ...........................24

Replacement Instructions ............................ 24

Specifications ..................................... 24

Cleaning and Sanitizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Parts List .........................................28

Warranty .........................................28

Technical Support and Product Return Information. . . . . . . . 29

Symbol Definitions .................................30

ENGLISH

CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A PHYSICIAN TRAINED IN THE
USE OF THE DEVICE.

Read all instructions, cautions and warnings prior to use. Failure
to follow any instructions or to heed any warnings or precautions
could result in serious patient injury.

NOTE: The manual that accompanied the disposable device may
contain a more recent revision of the NovaSuresystem instructions
than the manual provided with the controller.

The NovaSuredisposable device is not to be used with other
controllers and/or RF generators, and the NovaSureRFcontroller is
not to be used with other disposable devices.

The NovaSure disposable device does not contain latex.

Physician Checklist

The physician must:

• have sufficient experience in performing procedures within the uterine
cavity, such as IUD insertion or dilation and curettage (D&C) and with
adequate training, knowledge and familiarity using the NovaSure
system;

• review and be familiar with the instructions and complete either
NovaSure training or be trained by a qualified physician;

• be aware of the appropriate sequence of actions detailed in the
Instructions for Use and Troubleshooting sections of this manual to
abort, resolve and/or continue the treatment in the event the system
detects a loss of CO2 during the cavity integrity assessment (CIA),
which indicates a possible uterine perforation.

Adjunct personnel must be familiar with these instructions and other
training materials prior to using the NovaSure system.

System Description

The NovaSure impedance controlled endometrial ablation system
consists of the NovaSure disposable device with connecting cord,
NovaSure RF controller (controller), NovaSure CO2 canister, desiccant,
foot switch and power cord, which are designed to be used together as
a system.

NovaSure Disposable Device with Connecting Cord,

1

Including Suction Line Desiccant

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NovaSure Disposable Device Description

The NovaSure disposable device consists of a single-patient use,
conformable bipolar electrode array mounted on an expandable
frame that can create a confluent lesion on the entire interior
surface area of the uterine cavity. The disposable device is inserted
transcervically into the uterine cavity, and the sheath is retracted to
allow the bipolar electrode array to be deployed and conform to the
uterine cavity.

The bipolar electrode array is formed from a metalized, porous
fabric through which steam and moisture are continuously
suctioned from the desiccated tissue. The disposable device
works in conjunction with a dedicated NovaSure RF controller to
perform customized, global endometrial ablation in an average
of approximately 90seconds without the need for concomitant
hysteroscopic visualization or endometrial pretreatment. The
specific configuration of the bipolar electrode array and the
predetermined power of the controller create a controlled depth of
ablation in uteri sounding less than or equal to 10cm and having a
minimum cornu-to-cornu distance of 2.5cm.

During the ablation process, the flow of radio frequency (RF) energy
vaporizes and/or coagulates the endometrium regardless of its
thickness and desiccates and coagulates the underlying, superficial
myometrium.

The controller automatically calculates the optimal power level (W)
required for the treatment of the uterine cavity, based on uterine
size. As tissue destruction reaches an optimal depth, increasing
tissue impedance causes the controller to automatically terminate
power delivery, thereby providing a self-regulating process. Blood,
saline and other liquid present in the uterine cavity at the time
of the procedure, as well as vapor liberated from the desiccated
tissue, are evacuated by continuous, automatic suctioning.

The disposable device is connected to the controller via a cord
containing the RF cable, suction tubing used for pressure monitoring
during the cavity integrity assessment cycle and for suction during
the ablation cycle, and vacuum feedback tubing used for carbon
dioxide delivery during the cavity integrity assessment cycle and
vacuum monitoring during the ablation cycle. The disposable device
has been sterillized with ethylene oxide (EO).

NovaSure Model 08-09

RF Controllers

NovaSure Model 10

RF Controller

NovaSure RF Controller Description

The NovaSure RF controller is a constant power output generator with a
nominal maximum power delivery capability of 180 watts. The controller
automatically calculates the power output based on the uterine cavity
length (sound measurement minus the length of the endocervical canal)
and width measurements that the user key-enters into the controller.
Monitoring tissue impedance during the ablation process automatically
controls the depth of endo-myometrial ablation. The NovaSure procedure
self-terminates once endometrial vaporization and superficial myometrial
desiccation have reached 50ohms of impedance at the tissue-electrode
interface, or when the treatment timer reaches two minutes. Integral
to the controller is the cavity integrity assessment system (CIA) which
is designed to determine whether there is a defect or perforation in the
wall of the uterus. After the disposable device is placed into the uterine
cavity, CO2 is delivered through the central lumen of the disposable
device into the cavity, via the vacuum feedback tubing, at a safe flow
rate and pressure. If the CO2 pressure in the cavity is maintained for a
short period of time, indicating that the uterine cavity is intact, then the
CIA will allow the NovaSure RF controller to be enabled and proceed with
the treatment phase. A vacuum pump contained within the NovaSure
RF controller creates and maintains a vacuum in the uterine cavity
throughout the endometrial ablation procedure. Once the vacuum is
stabilized, the vacuum level is monitored throughout the remainder of
the ablation process.

2

NovaSure Suction Line Desiccant
Description

The NovaSure suction line desiccant
is a non-sterile, single-patient use
component that the user attaches
in-line with the suction tubing, prior
to connecting the disposable device
to the NovaSure RF controller. The
desiccant absorbs the moisture
removed from the uterine cavity via
the suction tubing during the ablation
procedure.

NovaSure Foot Switch
Description

The NovaSure foot switch is a
pneumatic switch that connects to the
NovaSureRFcontroller front panel. It
is used to activate the NovaSure RF
controller and does not contain any
electrical components.

NovaSure CO2 Canister
Description

The NovaSure CO2 canister is a 16­gram CO2 (USP) canister. It is attached
to the regulator located on the back
panel of the NovaSureRFcontroller
prior to applying line voltage to
the NovaSureRFcontroller. The
CO2 is used by the cavity integrity
assessment system to pressurize the
uterine cavity.

NovaSure AC Power Cord
Description

The NovaSure AC power cord,
a medical grade cord, connects
the NovaSure RF controller to
the appropriate line voltage. The
receptacle for the power cord, the
power input module, is located on
the back panel of the NovaSure RF
controller.

INDICATIONS

The NovaSure system is intended to ablate the endometrial lining of the
uterus in pre-menopausal women with menorrhagia (excessive bleeding)
due to benign causes for whom childbearing is complete.

CONTRAINDICATIONS

The NovaSure impedance controlled endometrial ablation system is
contraindicated for use in:

ENGLISH

• a patient who is pregnant or who wants to become pregnant in the
future. Pregnancies following ablation can be dangerous for both

mother and fetus.

• a patient with known or suspected endometrial carcinoma (uterine
cancer) or pre-malignant conditions of the endometrium, such as
unresolved adenomatous hyperplasia.

• a patient with 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.

• a patient with active genital or urinary tract infection at the time of
the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis or
cystitis).

• a patient with an intrauterine device (IUD) currently in place.
Presence of an IUD in the uterine cavity can interfere with a NovaSure

procedure.

• a patient with a uterine cavity length less than 4cm. The minimum
length of the electrode array is 4cm. Treatment of a uterine cavity with
a length less than 4cm will result in thermal injury to the endocervical
canal.

• a patient with a uterine cavity width less than 2.5cm, as determined
by the WIDTH dial of the disposable device following device
deployment.

• a patient with active pelvic inflammatory disease.

WARNINGS

FAILURE TO FOLLOW ANY INSTRUCTIONS OR FAILURE TO HEED
ANY WARNINGS OR CAUTIONS COULD RESULT IN SERIOUS PATIENT
INJURY.

THE NOVASURE DISPOSABLE DEVICE MUST BE USED ONLY IN
CONJUNCTION WITH THE NOVASURE RF CONTROLLER.

THE NOVASURE PROCEDURE IS INTENDED TO BE PERFORMED ONLY
ONCE DURING A SINGLE OPERATIVE VISIT. THERMAL INJURY TO THE
BOWEL MAY OCCUR WHEN MULTIPLE NOVASURE THERAPY CYCLES
ARE PERFORMED DURING THE SAME OPERATIVE VISIT.

Uterine Perforation

• Use caution not to perforate the uterine wall when sounding, dilating
or inserting the disposable device.

• If the disposable device is difficult to insert into the cervical canal,
use clinical judgment to determine whether or not further dilation is
required.

• The NovaSure system performs a cavity integrity assessment (CIA)
to evaluate the integrity of the uterine cavity and sounds an alarm
warning of a possible perforation prior to treatment (Step 2.36).

(Although designed to detect a perforation of the uterine wall, it is
an indicator only and it might not detect all perforations under all
possible circumstances. Clinical judgment must always be used.)

• If a uterine perforation is suspected, the procedure should be
terminated immediately.

3

ENGLISH

• If the cavity integrity assessment fails after reasonable attempts
to implement the troubleshooting procedures (step 2.36), abort
the procedure.

• For patients in whom the procedure was aborted due to a suspected
uterine wall perforation, a work-up for perforation should be
considered prior to discharge.

General

• Endometrial ablation using the NovaSure system is not a sterilization
procedure. Therefore, the patient should be advised of appropriate
birth control methods.

• Endometrial ablation does not eliminate the potential for endometrial
hyperplasia or adenocarcinoma of the endometrium and may mask the
physician’s ability to detect or make a diagnosis of such pathology.

• Endometrial ablation is intended for use only in women who do
not desire to bear children because the likelihood of pregnancy is
significantly decreased following the procedure. Pregnancy following
ablation may be dangerous for both mother and fetus.

• Patients who undergo endometrial ablation procedures who have
previously undergone tubal ligation are at increased risk of developing
post ablation tubal sterilization syndrome which can require
hysterectomy. This can occur as late as 10years post procedure.

• A health hazard may exist in the case where the NovaSure procedures
is performed in the presence of a thermally and electrically conductive

metal micro-insert that is improperly positioned (e.g., perforating the
fallopian tube or the myometrium). If this occurs, heat can be drawn
away from the intended treatment area toward other tissue and/or
organs in contact with the conductive object, which may be sufficient
to cause localized burns. As a result, correct placement of the metal
micro-insert must be confirmed prior to performing the NovaSure
procedure.

Technical

• Do not use the sterile, single-patient use disposable device if the
packaging appears to be damaged or there is evidence of tampering.

• The disposable device is for single-patient use only. Do not reuse or
re-sterilize the disposable device. The risk of reusing the disposable
device includes but is not limited to the following:

• ineffective procedure

• infection (major)

• electric shock

• transmission of communicable disease

• cervical laceration

• uterine perforation

• If any hysteroscopy procedure is performed with hypotonic solution
immediately prior to NovaSure treatment, then the uterine cavity must
be flushed with normal saline prior to treatment with the NovaSure
system. The presence of hypotonic fluid may reduce the efficiency of
the NovaSure system.

• Plugging the disposable device into the controller starts CO2 flow to
purge any air out of the disposable device and tubing. This purging

operation takes approximately 10seconds and must be performed

with the disposable device external to the patient to eliminate
the risk of air or gas embolism. The NovaSure RF controller CAVITY

ASSESSMENT LED flashes red (Model 08-09 RFCs) or a purging device
screen appears (Model 10 RFC) and an audible pulsed tone sounds
throughout the purge procedure. When the tone and the LED/screen
message stops it is safe to insert the disposable device.

• For patients with cardiac pacemakers or other active implants, a
possible hazard exists due to interference with the action of the
pacemaker that may occur and may damage the pacemaker. Consult
the pacemaker manufacturer for further information when use of the
NovaSure system is planned in patients with cardiac pacemakers.

• Care should be taken to ensure the patient does not contact metal
parts which are earthed or which have an appreciable capacitance to
earth.

• Danger: explosion hazard. Do not use in the presence of a flammable
anesthetic mixture. Do not use in the presence of flammable gases or
liquids.

• Failure of the NovaSureRFcontroller could result in an unintended
increase in output power.

PRECAUTIONS

• It has been reported in the literature that patients with a severely
anteverted, retroflexed or laterally displaced uterus are at greater risk
of uterine wall perforation during any intrauterine manipulation.

• A false passage can occur during any procedure in which the uterus
is instrumented, especially in cases of severe anteverted retroflexed
or a laterally displaced uterus. Use caution to ensure that the device is
properly positioned in the uterine cavity.

• The NovaSure system consists of the following components:

- single-patient use NovaSure disposable device with connecting cord

- NovaSure RF controller

- NovaSure CO2 canister

- NovaSure desiccant

- NovaSure foot switch

- power cord

To ensure proper operation, never use other components with the

NovaSure system. Inspect the components regularly for damage,
and do not use them if damage is apparent. The use of any cables or
accessories other than those specified in these instructions may result
in increased emissions or decreased immunity of the RF controller.

• The RF controller must be installed and put into service according
to the guidance provided in these instructions to ensure its
electromagnetic compatibility. Refer to the electromagnetic emissions
and immunity tables in the Specifications section.

• The RF controller should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the RF controller
should be observed to verify normal operation in the configuration in
which it will be used.

4

• Portable and mobile RF communications equipment can affect the
RF controller. Refer to the electromagnetic immunity tables in the
Specifications section for recommended separation distances.

• Patients who have undergone endometrial ablation and are later
placed on hormone replacement therapy should have a progestin
included in their medication regimen in order to avoid the increased
risk of endometrial adenocarcinoma associated with unopposed
estrogen replacement therapy.

• The safety and effectiveness of the NovaSure system has not been
fully evaluated in patients:

- with a uterine sound measurement greater than 10cm;

- with submucosal fibroids that distort the uterine cavity;

- with bicornuate, septate or sub-septateuteri;

- with medical (e.g., GnRH agonist) or surgical pretreatment;

- who have undergone a previous endometrial ablation including the

NovaSure endometrial ablation procedure; or,

- who are post-menopausal.

• Do not attempt to repair the controller if problems are suspected.
Call Hologic Technical Support or a Hologic sales representative for
instructions.

• Cables to the disposable device should be positioned such that contact
with patient or other leads is avoided.

• The user should inspect the disposable device for damage prior to use.

• The suction line desiccant is non-sterile, and the packaging should not
be placed in the sterile field.

• If the ARRAY POSITION LED light is illuminated on Models 08-

09, or an Array Position message is displayed on the Model 10
screen, see the Troubleshooting section under “ARRAY POSITION
ALARM”

• Do not use the NovaSure suction line desiccant if desiccant material is
pink in color.

• The disposable device must be external to (outside of) the patient
before connecting the cord to the appropriate port on the front panel of
the controller (step 2.15).

• The carbon dioxide canister contains gas under high pressure. In the
event of a breached CO2 canister or line, allow the canister to exhaust
completely, and allow the canister and/or lines to equilibrate to room
temperature prior to handling.

• CO2 continuously flows from the time that the disposable device is
plugged into the controller until the CIA portion of the procedure is
complete. To minimize the duration of CO2 flow and potential risk of
embolism, perform the seating procedure immediately after inserting
the disposable device and proceed directly from the seating procedure
to the CIA.

• Electrically conductive objects (e.g., monitoring electrodes from other
devices) that are in direct contact with the electrode array of the
disposable device or in close proximity to the electrode array may
draw current away from the array. This may result in localized burns
to the patient or physician or in distortion of the electrical field of the
array, which would change the therapeutic effect (under-treatment or

ENGLISH

over-treatment). It may also result in distortion of the current in the
conductive object, e.g., monitors may display false readings.

• Grounding reliability is only achieved when equipment is connected to
a receptacle marked “hospital grade”.

• To avoid risk to patient and operators, do not use this equipment in
the presence of intentional magnetic sources, intentional ultrasound
sources, or intentional heat sources.

• The cervical collar must be fully retracted to its proximal position in
order to minimize the potential for damage to the sheath when closing
the array.

• The plastic tubing in the NovaSure Disposable Device contains di-(2­ethylhexyl) phthalate; DEHP. In accordance with European Commission
Directive 67/548/EEC, it is noted here that DEHP may impair fertility;
it also may cause harm to the unborn child. The NovaSure device is
contraindicated for use in pregnant women or women that want to
become pregnant in the future. Pregnancies following ablation can be
dangerous for both mother and fetus. Sound medical judgment should
be used.

NovaSure 3-Year Clinical Data

Adverse Events

The NovaSure system was evaluated in a randomized, prospective,
multi-center clinical study of 265patients with abnormal uterine
bleeding comparing the NovaSure system to a control arm of wire loop
resection of the endometrium followed by rollerball ablation.

Table 1A. Intra-Operative Adverse Events

NovaSure

Adverse Event

Bradycardia

Uterine perforation

Cervical tear

Cervical stenosis

TOTAL

Table 1B. Post-Operative Adverse Events < 24 Hours

Adverse Event

Pelvic pain/cramping 6 (3.4%) 4 (4.4%)

Nausea and/or vomiting 3 (1.7%) 1 (1.1%)

TOTAL 9 (5.1%)* 5 (5.6%)**

* Nine events reported in 6 (3.4%) patients
** Five events reported in 4 (4.4%) patients

n=175 (%)

1 (0.6%) 0 (0.0%)

0 (0.0% 3 (3.3%)

0 (0.0% 2 (2.2%)

0 (0.0% 1 (1.1%)

1 (0.6%) 6 (6.7%)

NovaSure

n=175 (%)

Loop Resection

Plus Rollerball

n=90 (%)

Loop Resection

Plus Rollerball

n=90 (%)

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Table 1C. Post-Operative Adverse Events > 24 Hours – 2 Weeks

NovaSure

Adverse Event

Hematometra 1 (0.6%) 0 (0.0%

Urinary tract infection 1 (0.6%) 1 (1.1%)

Vaginal infection 1 (0.6%) 0 (0.0%

Endometritis 0 (0.0% 2 (2.2%)

Pelvic inflammatory disease 0 (0.0% 1 (1.1%)

Hemorrhage 0 (0.0% 1 (1.1%)

Pelvic pain/cramping 1 (0.6%) 1 (1.1%)

Nausea and/or vomiting 1 (0.6%) 1 (1.1%)

TOTAL 5 (2.9%)* 7 (7.8%)**

* Five events reported in 4 (2.3%) patients
** Seven events reported in 6 (6.7%) patients

Table 1D. Post-Operative Adverse Events > 2 Weeks – 1 Year

Adverse Event

Hysterectomy 3 (1.7%) 2 (2.2%)

Hematometra 1 (0.6%) 2 (2.2%)

Urinary tract infection 2 (1.1%) 2 (2.2%)

Vaginal infection 5 (2.9%) 2 (2.2%)

Endometritis 2 (1.1%) 1 (1.1%)

Pelvic inflammatory disease 2 (1.1%) 0 (0.0%

Hemorrhage 1 (0.6%) 0 (0.0%

Pelvic pain/cramping 5 (2.9%) 6 (6.7%)

TOTAL 21 (12.0%)* 15 (16.17%)**

* 21 events in 19 (10.9%) patients
** 15 events in 15 (16.7%) patients

n=175 (%)

NovaSure

n=175(%)

Loop Resection

Plus Rollerball

n=90 (%)

Loop Resection

Plus Rollerball

n=90 (%)

Anticipated Post-Procedural Complications

For any endometrial ablation procedure, commonly reported post­operative events include the following:

• Cramping/pelvic pain was reported for 3.4% of the NovaSure patients
and 4.4% of the wire resection loop plus rollerball-treated patients
within 24hours of the procedure. Postoperative cramping can range
from mild to severe. This cramping will typically last a few hours and
rarely continues beyond the first day following the procedure.

• Nausea and vomiting were reported for 1.7% of the NovaSure patients
and 1.1% of the wire loop resection plus rollerball patients within
24hours of the procedure. When present, nausea and vomiting
typically occur immediately following the procedure, are associated
with anesthesia and can be managed with medication.

• Vaginal discharge

• Vaginal bleeding/spotting

Other Adverse Events

As with all endometrial ablation procedures, serious injury or death can occur.

The following adverse events could occur or have been reported in
association with the use of the NovaSure system:

• post-ablation tubal sterilization syndrome

• pregnancy-related complications (NOTE: PREGNANCY FOLLOWING
ENDOMETRIAL ABLATION IS VERY DANGEROUS FOR BOTH THE
MOTHER AND THE FETUS.)

• thermal injury to adjacent tissue

• perforation of the uterine wall

• difficulty with defecation or micturition

• uterine necrosis

• air or gas embolism

• infection or sepsis

• complications leading to serious injury or death

Clinical Study

Purpose: Safety and effectiveness of the use of the NovaSure system
was compared to wire loop resection of the endometrium followed by
rollerball ablation in premenopausal women suffering from menorrhagia
secondary to benign causes.

Pretreatment: Patients randomized into the NovaSure arm received
no endometrial pretreatment (e.g., hormone, D&C or patient timing).
Patients randomized into the control arm received wire loop resection as
an endometrial pretreatment.

Study endpoints: The primary effectiveness measure was a validated
menstrual diary scoring system developed by Higham (Higham JM,
O’Brien PMS, Shaw RW Br J Obstet Gynaecol 1990; 97:734-9).
Assessment of menstrual blood loss was performed using a pictorial
blood loss assessment chart (PBLAC). Patient success was defined as
a reduction in menstrual flow at 1 year post-procedure to a diary score
of <75. Study success was defined as a statistical difference of less
than 20% in patient success rates between the NovaSure impedance
controlled endometrial ablation system and wire loop resection plus
rollerball ablation. Patients were contacted at two and three years and
asked a series of questions regarding their bleeding over the previous
12months. Each patient’s menstrual bleeding status was determined
at two and three years using the one-year PBLAC score and bleeding
pattern as a reference. Thus, it was possible to directly compare a
patient’s bleeding pattern or menstrual status at one year to the bleeding
pattern at two and three years.

Secondary endpoints included anesthesia regimen, length of procedure
and responses from a quality-of-life questionnaire. Safety evaluation was
based on the adverse events reported during the study.

Methods: A randomized (2:1), prospective clinical study was conducted
at 9clinical sites and included 265patients diagnosed with menorrhagia.
Menstrual diary scores were collected pre-operatively and monthly for
12months post-procedure. Patients were treated at any time in their
menstrual cycle. None of the patients received hormonal pretreatment
to thin the endometrial lining. Control patients received hysteroscopic

6

wire loop resection of the endometrium as a mechanical means of
endometrial pretreatment followed by rollerball ablation. Study subjects
were required to meet the following key patient selection criteria:

Inclusion criteria

• Refractory menorrhagia with no definable organic cause (dysfunctional
uterine bleeding)

• Ages 25 to 50years of age

• Uterine sound measurement of 6.0–10.0cm (external os to internal
fundus)

• Minimum PBLAC score of >150 for 3months prior to study enrollment;
or PBLAC score >150 for one month for women who:

- had at least 3 prior months (documented) failed medical therapy;

- had a contraindication to medical therapy; or

- refused medical therapy.

Exclusion criteria

• Presence of bacteremia, sepsis or other active systemic infection

• Active or recurrent chronic pelvic inflammatory disease

• Patient with documented coagulopathies or on anticoagulants

• Symptomatic endometriosis

• Prior uterine surgery (except low segment cesarean section)
that interrupts the integrity of the uterine wall e.g., transmural
myomectomy or classical cesarean section

• Prior endometrial ablation

• Patient on medications that could thin the myometrial muscle, such as
long-term steroid use

• Patient desire to have children or to preserve fertility

• Patient currently on hormonal birth control therapy or unwilling to use
a non-hormonal birth control post-ablation

• Abnormal/obstructed cavity as confirmed by hysteroscopy, SIS or HSG.
Specifically:

- septate or bicornuate uterus or other congenital malformation of the

uterine cavity

- pedunculated, submucous leiomyomata or other leiomyomata which

distort the cavity; polyps (larger than 2cm) which are likely to be the
cause of the patient’s menorrhagia

- presence of an IUD

• Suspected or confirmed uterine malignancy within the last five years
as confirmed by histology

• Endometrial hyperplasia as confirmed by histology

• Unaddressed cervical dysplasia

• Elevated FSH levels consistent with ovarian failure >40IU/ml

• Pregnancy

• Active sexually transmitted disease

Patient population: A total of 265patients were enrolled in this study.
Patients were between the ages of 25 to 50 with 46% under the age
of 40 and 54% 40years of age or older. There were no differences in
demographic or gynecological history parameters between the treatment
groups, between the age groupings or among the nine investigational sites.

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Table 2. Patient Accountability

Number of Patients NovaSure Wire Loop

Resection

Plus Rollerball

Entered into Study
(Intent-to-Treat population)

Aborted procedures*

Treated 171 88

Additional treatment* -4 -2

Hysterectomy*

Lost to follow-up* -5 -2

Hodgkin’s disease* -1 0

Pelvic Pain - administered
leuprolide*

12-Month
follow-up data available

Additional treatment* -2 -1

Hysterectomy*

Lost to follow-up* -2 -5

Missed visit -1 -1

Declined to participate* -1 0

Pregnancy* -1 0

24-Month
follow-up data available

Additional treatment* 0 -4

Hysterectomy*

Lost to follow-up* -4 -2

36-Month follow-up 138 67

Subject lost to follow-up at
24 mos., returned at 36 mos.

36-Month follow-up data
available

* Discontinued patients

1

Four NovaSure did not meet protocol Inclusion Criteria; Two Rollerball had uterine perforation

2

For hysterectomy, see Table 7

1

2

2

2

175 90

-4 -2

-3 -2

-1 0

157 82

-3 -1

147 74

-5 -1

+1 +1

139 68

Results

Primary effectiveness endpoint: bleeding score

Patient success at 12-months post-procedure is defined as a reduction
in diary score from >150 pre-operatively to <75 post-procedure.
Amenorrhea is defined as a score of 0. Success at 24 and 36 months,
based on telephone questionnaires, is defined as elimination of bleeding
or reduction to light or normal flow. Data presented in Table 3 (below)
represent the clinical results based on the total number of 265 patients
randomized (Intent-to-Treat group (ITT)) for the study. The worst-case
scenario is presented whereby each of the discontinued patients

7

ENGLISH

(described in Table 2 for patient accountability) is counted as a “failure”
for calculating the values listed in the table.

Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients

Wire Loop Resection

NovaSure

(n=175)

Plus Rollerball

(n=90)

Months post ablation 12* 24** 36** 12* 24** 36**

Number of
successful patients 136 143 134 67 68 63

Study success rate 77.7% 81.7% 76.6% 74.4% 75.6% 70.0%

# of patients with
Amenorrhea 63 64 58 29 26 23

Amenorrhea rate 36.0% 36.6% 33.1% 32.2% 28.9% 25.6%

* Based on diary scores
** Based on telephone questionnaires

Secondary effectiveness endpoint: quality of life

Patient quality of life (QOL) was assessed by administering the quality of
life questionnaire (SF-12) and the menstrual impact questionnaire prior
to treatment and at 3, 6, 12, 24 and 36months post-procedure. Table4
shows the patient responses for both groups pre-operatively, where
appropriate, and at 12, 24 and 36months post-procedure.

Table 4. Effectiveness: Quality of Life (QOL)

Wire Loop Resection

NovaSure

Number of Patients Responding to Quality of Life Questionaire

Pre-operatively 175 90
12 Months 154 82
24 Months 143 73
36 Months 139 67

Percent of Patients Satisified Or Very Satisified

12 Months 92.8% 93.9%
24 Months 93.9% 89.1%
36 Months 96.3% 89.7%

Percent of Patients Who Probably Or Definitely Would Recommend
This Procedure

12 Months 96.7% 95.9%
24 Months 96.6% 94.5%
36 Months 97.8% 92.6%

Percent of Patients with Dysemenorrhea

Pre-operatively 57.1% 55.6%
12 Months 20.8%

&

24 Months 20.3%* 30.1%*
36 Months 17.3%* 28.4%*

Percent of Patients with PMS

Pre-operatively 65.1% 66.7%
12 Months 36.4%* 35.4%*
24 Months 44.0%* 46.6%*
36 Months 34.5%* 41.2%*

Plus Rollerball

34.2%

#

*,&

Table 4. Effectiveness: Quality of Life (QOL)

Wire Loop Resection

NovaSure

Plus Rollerball

Percent of Patients Reporting Sometimes, Frequently Or Always
Have Difficulty Performing Work Or Other Activities Due to Menses

Pre-operatively 66.3% 65.5%
12 Months 9.9%* 8.6%*
24 Months 14.5%* 15.0%*
36 Months 16.3%* 13.3%*

Percent of Patients Reporting Sometimes, Frequently Or Always
Feel Anxious Due to Menses

Pre-operatively 74.7% 68.9%
12 Months 23.6%* 18.5%*
24 Months 24.2%* 19.2%*
36 Months 18.7%* 19.1%*

Percent of Patients Reporting Sometimes, Frequently Or Always
Miss Social Activities Due to Menses

Pre-operatively 63.3% 62.2%
12 Months 8.5%* 8.6%*
24 Months 9.0%* 11.1%*
36 Months 8.1%* 10.8%*

# Not all patients completed questionnaire
* Statistically significant difference from pre-operative response (Chi-Square; p<0.05)
& Statistically significant difference between NovaSure and Rollerball Groups
(Chi-Square; p=0.02)

Safety endpoint

Adverse event information is described in the “Adverse Events” section of this manual.

Secondary endpoint: procedure time

Procedure time, a secondary endpoint, was determined for each patient
by recording the time of device insertion and the time of device removal.
The mean procedure time for the NovaSure patients was significantly
less than the procedure time for the rollerball group, (4.2 ±3.5 minutes
and 24.2 ±11.4 minutes, respectively). Mean time for application of RF
energy was 84.0 ±25.0 seconds in a subset of monitored NovaSure
patients (Table5).

Table 5. Operative Procedure Time

Wire Loop Resection

NovaSure

Operative Parameters

n=175

Number of treated patients* 171 88

Procedure time minutes (± SD)

4.2 ± 3.5** 24.2 ± 11.4**

(Device insertion to device
removal)

Procedure time in seconds (±SD)

84.0 ± 25.0 ND

(Time of energy delivery)

* See Table 2 for patient accountability
** Statistically significant difference between treatment groups (Student’s t-test; p < 0.05)

#

Not determined

Plus Rollerball

n=90

#

8

Secondary endpoint: anesthesia regimen

Anesthesia was left to the discretion of each patient, clinical investigator
and attending anesthesiologist. For the NovaSure patients, 27.0%
(47/174) had the procedure performed under general anesthesia or
epidural and 73.0% (127/174) under local and/or IV sedation. One
patient did not have a reported anesthesia regimen in this group. In
the rollerball group, 82.2% (74/90) of the patients were treated under
general anesthesia or epidural and 17.8% (16/90) under local and/or IV
sedation (Table6).

Table 6. Anesthesia Regimen

Wire Loop Resection

NovaSure

n=175*

General or epidural 27.0% 82.2%

Local and/or IV sedation 73.0% 17.8%

* One patient did not have a reported anesthesia regimen.

Plus Rollerball

n=90

Clinical observations

Hysterectomy

Fifteen women had a hysterectomy within the three years following the
ablation procedure. Table7 lists the reasons for hysterectomy.

Table 7. Hysterectomy

Wire Loop Resection

NovaSure

Reason For Hysterectomy

Adenocarcinoma diagnosed at
time of ablation procedure

Fibroids 2 0

Pelvic abscess 1 1

Endometriosis 3 0

Adenomyosis 4 0

Hematometra 0 1

Menorrhagia 0 1

TOTAL 11 (6.3%) 4 (4.4%)

7Hysterectomies were in patients <40years (7 NovaSure) and 8hysterectomies were in patients >40years
(4NovaSure; 4 Rollerball).

n=175

1 1

Plus Rollerball

n=90

Patient Selection

Menorrhagia can be caused by a variety of underlying problems,
including, but not limited to; endometrial cancer, myomas, polyps, drugs
and dysfunctional uterine bleeding (anovulatory bleeding). Patients
always should be screened and evaluated to determine the cause of
excessive uterine bleeding before any treatment option is initiated.
Consult medical literature relative to various endometrial ablation
techniques, indications, contraindications, complications and hazards
prior to the performance of any endometrial ablation procedure.

ENGLISH

Patient Counseling

As with any procedure, the physician needs to discuss risks, benefits
and alternatives with the patient prior to performing endometrial
ablation. Patient’s expectations should be set in a way that the patient
understands that the aim of the treatment is the reduction in bleeding to
normal levels.

The disposable device is intended for use only in women who do
not desire to bear children because the likelihood of pregnancy is
significantly decreased following the procedure. Patients of childbearing
capacity should be cautioned of potential complications, which may
ensue if they should become pregnant. This counseling should include
the need for post-procedure contraception where indicated. This
procedure is not a sterilization procedure and subsequent pregnancies
may be dangerous for the mother and fetus.

Vaginal discharge is typically experienced during the first few weeks
following ablation and may last as long as a month. Generally,
the discharge is described as bloody during the first few days;
serosanguineous by approximately one week; then profuse and watery
thereafter. Any unusual or foul-smelling discharge should be reported to
the physician immediately. Other common post-procedural complications
include cramping/pelvic pain, nausea and vomiting.

Uterine perforation should be considered in the differential diagnosis of
any post-operative patient complaining of acute abdominal pain, fever,
shortness of breath, dizziness, hypotension or any other symptom that
may be associated with uterine perforation with or without damage
to the adjacent organs of the abdominal cavity. Patients should be
counseled that any such symptoms should be immediately reported to
their physician.

Pretreatment Preparation of Patient

The NovaSure impedance controlled endometrial ablation system
successfully treats a uterine cavity over a range of endometrium
thickness. The lining of the uterus does not have to be thinned prior to
the procedure, and the procedure may be performed during either the
proliferative or the secretory phase of the cycle. Although the safety and
effectiveness of the NovaSure system has not been fully-evaluated in
patients with medical or surgical pretreatment, it has been evaluated in a
limited number of patients who had been pretreated with GnRH agonists
with no complications or adverse events.

Active bleeding was not found to be a limiting factor when using
the NovaSure system. It is recommended that a nonsteroidal anti­inflammatory drug (NSAID) be given at least one hour prior to treatment
and continued postoperatively to reduce intraoperative and postoperative
uterine cramping.

9

ENGLISH

NovaSure Impedance Controlled Endometrial Ablation System
Instructions For Use

Please read all instructions, cautions and warnings prior to use.

1.0 Se t-up

1.2 Prepare the NovaSure RF controller. Place it on a small table to one
side of the patient within visual field of the surgeon. Attach the AC
power cord to the controller and plug it into the AC outlet.

1.3 Screw the CO2 canister into the regulator on the back panel of the
controller until tightened.

Toggle
switch

NOVASURE DISPOSABLE DEVICE

WITH CONNECTING CORD,

NOVASURE

RF CONTROLLER

NOVASURE POWER CORD

NOVASURE CO2 CANISTER NOVASURE FOOT SWITCH

INCLUDING SUCTION LINE

DESICCANT

NOVASURE SUCTION LINE

1.1 The following items are required when using the NovaSure system:

• one sterile, single-patient use NovaSure disposable device with
connecting cord

• one NovaSure RF controller

• one NovaSure foot switch

• one NovaSure AC power cord

• one NovaSure non-sterile suction line desiccant assembly

• one NovaSure CO2 canister.

Lock Release
Button

WIDTH Dial

Suction
Line

Rear
Handle

Cavity Length Setting

Vacuum
Relief Valve

Vacuum
Feedback
Line Barb

Front Handle

Cervical Collar

Sheath

Bipolar
Electrode
Array

NOTE: Please have available at least one extra disposable device,
desiccant assembly and CO2 canister.

AC
power
cord

CO2 canister

1.4 Fully rotate the CO2 regulator knob to the HI position (if equipped).

NOTE: Newer model controllers are not equipped with a knob on the
regulator, thus allowing the CO2 flow to be automatically regulated.
If your controller is not equipped with a regulator knob, proceed to
step1.5.

1.5 Press the toggle switch on the back panel of the controller into the
“on” position.

1.6 Connect the foot switch to the appropriate port on the front panel of
the controller.

Port

NOTE: The first time the Model 10 RFC is turned on, the “Select Your

Language” screen will display. The default setting is in English.
To select another language, press the button with the name
of that language. Save the selection by pressing the flashing
green button.

The language selection will be retained. To change the language
selection after the initial setup, use the “Settings” screen. Press the
name of the language to change the language used on the screen
display. To save changes to the settings, press the flashing green
button. To cancel a selection, press the Blue “X”.

2.0 Procedure

2.1 Prepare the patient for the anesthesia.

2.2 Place patient in dorsal lithotomy position.

2.3 Induce anesthesia according to standard practice.

2.4 Perform bimanual examination. Evaluate for severe anteversion or
retroversion.

10