Thermablate Endometrial Ablation System (EAS) Profile
The Thermablate EAS has 4 main components:
Treatment Control Unit (TCU, Reusable Unit)
Disposable Cartridge (Single-Use Unit)
Power Supply
TCU Stand
Endometrial Ablation
It has been estimated that approximately 20% of otherwise healthy women worldwide
suffer from excessive uterine bleeding.
Of the ~600,000 hysterectomies performed annually in the United States and ~60,000
in Canada, about a quarter are for the relief of menorrhagia (excessive uterine bleeding
without underlying pathology), and hysterectomy is still the leading treatment of menorrhagia
despite the morbidity associated with the invasiveness of the procedure.
During the last 2 decades, however, there has been clear progress in the search for
a less invasive but still effective treatment with lower risk of complications. Initially,
hysteroscopic endometrial ablation techniques such as rollerball and loop-resection provided
a safe and effective alternative to hysterectomy although their use requires a high degree
of skill not attained by most gynecologists.
More recently, a number of devices have been developed to treat menorrhagia by non-hysteroscopic
ablative methods (i.e. performed “blind”) – the advantage
of these being that they require a lot less physician skill to use successfully
and typically have reduced risk of complications. The emerging trend today,
however, is toward simpler, quicker procedures that can take place in an outpatient
or office setting if desired.
A great source for independent and thorough medical research is the
National Institute for Clinical Excellence (NICE) website.
NICE is part of the National Health Service (NHS) in the UK and was set up as a Special
Health Authority for England and Wales in 1999.
NICE's role is “to provide patients, health professionals and the public with authoritative,
robust and reliable guidance on current 'best practice'”. “The guidance will cover both
individual health technologies (including medicines, medical devices, diagnostic techniques,
and procedures) and the clinical management of specific conditions” and “will help to
inform...decisions about treatment and healthcare. Our guidance recommendations are prepared
by independent teams of 'experts', who include healthcare professionals working in the NHS
and lay people who are familiar with the issues affecting patients and carers”.
In July, 2003 the NICE Final Appraisal Determination (FAD) on
Fluid-filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual
bleeding was released.
This document is very helpful in understanding what MDMI's Thermablate EAS is designed to treat
and why it is beneficial to both patients and health care systems. In addition to providing
a succinct definition of menorrhagia and describing the different methods of competing treatments
and devices currently available for it the FAD interprets the clinical and cost effectiveness
of the devices and makes some recommendations for future research.
Principles of Operation
The Thermablate EAS accomplishes endometrial ablation by using a high-temperature
fluid to deliver heat to the endometrium (inside lining of the uterus).
The device consists essentially of the Treatment Control Unit (TCU) and the Disposable
Cartridge.
The Disposable Cartridge contains a silicone reservoir and a silicone balloon connected
by an insulated tube. The cartridge is filled with a biocompatible fluid, which is heated
to 173°C in the reservoir before the treatment commences.
Once the balloon has been inserted into the uterine cavity and the user depresses
the trigger button, a pneumatic pump applies pressure to the reservoir and fluid
is forced into the balloon. A pressure of 180-200 mmHg is applied to the treatment
fluid – this increases treatment efficacy by ensuring good contact of
the balloon with the endometrial wall and reducing blood perfusion in the endometrium
and inner myometrium. During treatment the pressure is pulsed periodically to
help mix the fluid within the balloon. This ensures a uniform temperature distribution
in the balloon and promotes a uniform treatment of the uterus. The temperature
of the fluid in the balloon is approximately 155°C when it first enters
the uterus, and declines to approximately 115°C by the end of the 128 second
treatment period. The temperature of the endometrium is elevated significantly
during treatment causing tissue necrosis, whereas the temperature of the myometrium
is only mildly elevated and is therefore left unharmed.
Physical Characterisitics
Treatment Control Unit (TCU)
Dimensions
Length
27.1 cm (10.7 inches)
Width
8.9 cm (3.5 inches)
Height
10.5 cm (4.13 inches)
Weight
Approximately 830g (1 lb 13 oz)
Disposable Cartridge
Dimensions
Cartridge Length
31.3 cm (12.3 inches)
Connector
5.5 cm x 5.5 cm (2.2 inches x 2.2 inches)
Insertion Length
12 cm (4.72 inches)
from insertion stop to balloon tip
Weight
Each Disposable Cartridge weighs approximately 110g (4 oz)
Power Supply
Dimensions
Total Power Cord Length
3.6 m (11.8 feet)
Power Supply Length
16.5 cm (6.5 inches)
Power Supply Width
10.2 cm (4 inches)
Power Supply Height
5.1 cm (2 inches)
TCU Stand
Dimensions
Length
13.5 cm (5.3 inches)
Width
10.2 cm (4.0 inches)
Height
10.0 cm (3.9 inches)
Operative Characteristics
Treatment Control Unit (TCU)
This handheld reusable unit carefully controls all treatment
parameters (time, pressure, and temperature): the TCU operates
a precise electromechanical heating and pumping/draining system
that, in 128 seconds, delivers an effective and homogeneous
treatment. The TCU has an LCD Display that provides pertinent
information to the user: warming-up cycle, balloon leak test,
treatment cycle, and completion of treatment are all clearly
indicated.
Disposable Cartridge
The Disposable Cartridge is made up of the connector, catheter,
and balloon. The actual treatment component of the Thermablate
EAS is the balloon, which makes contact with the endometrial
tissue and directly performs thermal ablation.
Power Supply
The TCU is powered with a 24-VDC Power Supply specially
designed for medical application. The input is 110/220-VAC,
and it has an input-to-output isolation of 4000 VAC. It
meets the following electrical safety and EMI standards:
UL2601-1
CSA C22.2 No. 601-1
IEC 601-1 (EN 600601-1)
CISPR 11 (EN55011) Class B
TCU Stand
The TCU Stand provided with the Thermablate EAS is
a robust and stable support that holds the TCU in horizontal
position while the system performs its fast warm-up prior
to use. It provides a sanitary rest when the unit is not
in use.
* All components are latex-free and the system is supplied
within a carrying/storage case.
Testimonials
“…I am very impressed with its performance…I found it to
be light, very portable and easy to handle. The mechanism is simple, easy to
set up and easy to operate.”
- Dr. B.P., Abbotsford, 1-27-03
“I was extremely impressed with the Thermablate device, which is the
most user-friendly method of endometrial ablation I have encountered to date.
The size of the device, the simplicity of use, the short 2 minute 8 second treatment
cycle and the built in safety features of the device are most impressive.”
- Dr. S.K., Vancouver, 1-23-03
“Having used various other thermal ablation techniques,
I would like to congratulate you (MDMI) for your innovative equipment.”
- Dr. H.M., Richmond, 12-09-02
“The portability and simplicity of the Thermablate
device… and the lower treatment time will certainly make this a
procedure that could be used on an out-patient or even ultimately on an
office basis which certainly would be cost conserving.”
- Dr. H.R., Richmond, 11-28-02
“I believe that the Thermablate system takes balloon
ablation into the next phase. The simplicity and ease of use make this
a quicker and safer device than its predecessors. The fact that ablation
with this device can be carried out in an outpatient setting represents
a significant advantage both to the patient - who avoids an anaesthetic
and the hospital - as a cost saving measure… We are always looking
for Safer, Faster more Effective and Efficient techniques in medicine
and I believe the Thermablate system achieves all these goals.”
- Dr. S.T., Abbotsford, 11-26-02
“…2 minutes to work, unbelievable. We have
taken up to 2 hours to do this same procedure…It was such a pleasure
to have been in a balloon therapy case that took no time at all with a
very compromised patient.”
- Clinical RN, Richmond, 10-07-02
“The Thermablate EAS System is sophisticated and yet very simple and
easy to use and very effective for its purpose…it outperformed other similar
systems I have used… Thank you for the opportunity to improve patient
care with such an effective tool.... I was particularly concerned about this
patient’s medical complications. This patient suffered from Sleep Apnea,
smokes a pack and a half per day of cigarettes and weighs over 300 pound (140Kg)…the
Thermal Ablation System performed superbly and we were able to complete the
procedure under local infiltration and IV sedation in two and a half minutes.”
