FMsealer Laparoscopic Shears are an intelligent, multifunctional
thermal vessel sealing instrument that uses ferromagnetic technology
to efficiently seal and divide tissue with minimal lateral thermal
spread in laparoscopic and open surgical procedures.
Reliable sealing
of vessels up to
7 mm in diameter,
including lymphatics
Faster dissection
times than competitive
instruments through
vascular tissue bundles
Precise control of
heat, with less lateral
thermal spread than
competitive instruments
No stray electrical
current, no risk of
capacitive coupling,
safe to use around
metal staples and clips
Domain Surgical
1370 South 2100 East
Salt Lake City, UT 84108
(801) 924-4950
email: [email protected]
web: domainsurgical.com
FMsealer Laparoscopic Shears are a component
of the
Ferromagnetic Surgical System
To watch surgical videos of
FMX instruments in action, visit
domainsurgical.com/video
To learn how ferromagnetic
technology works, visit
domainsurgical.com/fmx
For additional information on the advantages and safety considerations of the FMX System, please visit domainsurgical.com.
For patent information, please visit domainsurgical.com/patent. © 2016 Domain Surgical, Inc. All rights reserved. LB-054 Rev. B
A multifunctional vessel sealing instrument that delivers
reliable sealing with precise control of thermal effect
FMsealer Laparoscopic Shears are an intelligent, multifunctional
thermal vessel sealing instrument that uses ferromagnetic technology
to efficiently seal and divide tissue with minimal lateral thermal
spread in laparoscopic and open surgical procedures.
Reliable sealing
of vessels up to
7 mm in diameter,
including lymphatics
Faster dissection
times than competitive
instruments through
vascular tissue bundles
Precise control of
heat, with less lateral
thermal spread than
competitive instruments
No stray electrical
current, no risk of
capacitive coupling,
safe to use around
metal staples and clips
Domain Surgical
1370 South 2100 East
Salt Lake City, UT 84108
(801) 924-4950
email: [email protected]
web: domainsurgical.com
FMsealer Laparoscopic Shears are a component
of the
Ferromagnetic Surgical System
To watch surgical videos of
FMX instruments in action, visit
domainsurgical.com/video
To learn how ferromagnetic
technology works, visit
domainsurgical.com/fmx
For additional information on the advantages and safety considerations of the FMX System, please visit domainsurgical.com.
For patent information, please visit domainsurgical.com/patent. © 2016 Domain Surgical, Inc. All rights reserved. LB-054 Rev. B
A multifunctional vessel sealing instrument that delivers
reliable sealing with precise control of thermal effect
The FMsealer sealed vessels with clinically reliable burst pressures consistent with other
technologies currently available. The FMsealer compared favorably with the other technologies
in speed and efficiency as well as tissue effects, including thermal spread and injury.
Chen J, Manwaring PK, Scott RR, Manwaring KH, Glasgow RE. Ferromagnetic Heating for Vessel Sealing and Division:
Utility and Comparative Study to Ultrasonic and Bipolar Technologies. Surgical Innovation. 2015.
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in laparoscopic and open procedures
Electrically silent operation, no
stray current, safe to use around
metal staples and clips
FMmin and FMmax activation modes
Patented active cooling system
ensures localization of heat in
the jaws and rapid cool down
Reliable Vessel Sealing
Speed and Efficiency
Minimal Thermal Injury
Vessel sealing reliability and burst pressure measurements are comparable
to LigaSure bipolar laparoscopic vessel sealing instruments†
No stray electrical current passes through the patient, no risk of
capacitive coupling, safe to use around metal staples and clips
Faster sealing and dividing cycles
than competitive instruments†
Dual activation modes put full control of
thermal effect in the hands of the surgeon
Pure thermal effect with less lateral thermal spread than LigaSure bipolar
and Harmonic ultrasonic laparoscopic vessel sealing instruments†
FMsealer Laparoscopic Shears are actively cooled, providing lower operating
temperatures than Harmonic ultrasonic laparoscopic vessel sealing instruments†
Sealing Reliability Analysis
Burst Pressure Analysis
Dissection Speed Test
Lateral Thermal Spread Analysis
Vessel sealing tests were performed using FMsealer
Laparoscopic Shears and LigaSure laparoscopic vessel
sealing instruments on porcine arteries ranging between
3 and 7 mm in diameter in a controlled laboratory
setting. The percentage of overall seals that resulted in
burst pressures above 240 mmHg, are shown below.†
Burst pressure comparisons were performed using FMsealer
Laparoscopic Shears and LigaSure laparoscopic vessel sealing
instruments on porcine arteries ranging between 3 and 7 mm
in diameter. Each vessel was sealed, divided, and pressurized
using an automated inflation system until the seal failed.
Average burst pressure results in mmHg are shown below.†
Speed tests were performed using FMsealer Laparoscopic
Shears, LigaSure, and Harmonic laparoscopic vessel sealing
instruments. A 10 cm section of porcine mesentery was
measured and marked prior to dissection. Each instrument was
used to seal and divide the pre-measured segments. Multiple
rounds were completed with each instrument, and the average
time to complete each 10 cm dissection is shown below.†
To determine lateral thermal spread, porcine arteries ranging between 4 and 5 mm in diameter were sealed and divided using FMsealer
Laparoscopic Shears, LigaSure, and Harmonic laparoscopic vessel sealing instruments. After sealing and dissection, each artery
was harvested. HE staining and histologic assessment of lateral thermal spread was performed by an independent reviewer. Lateral
thermal spread was determined to be the maximum distance thermal injury extends laterally from the edge of the instrument.†
1300
96%
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
Compatible with
reusable or disposable
FMX Power Modules
1100
92%
1000
30.0
0.3
1.3
90%
91%
success
success
800
700
600
mmHg
500
84%
400
82%
896
mmHg
SD =
Harmonic
n = 10
1.5
1.6
1.7
1.8
1.9
2.03
mm
1.68
mm
2.0
2.1
2.2
2.3
2.4
Seal Only Mode: Used to seal large vessels; > 2 mm in diameter*
FMsealer
activation
modes and
power settings
Pulsed audio tone indicating activation of vessel sealing cycle - followed by three short beeps indicating
completion of the cycle. If desired, FMmax button can be activated to divide the sealed vessel
SD = .43
26.8
seconds
350
SD = 402
Seal & Divide Mode: Used to seal & divide large vessels;
> 2 mm in diameter* with single button activation
Pulsed audio tone indicating activation of vessel sealing cycle - followed by continuous audio
tone indicating automatic transition to delivery of high power energy to divide the sealed vessel
High Power Seal & Divide Mode: Used to quickly seal & divide
vascular tissue bundles, membranes, and small vessels
Continuous audio tone indicating activation of high power energy to simultaneously
seal & divide tissue bundles, membranes, and small vessels
* Based on surgeon experiences and feedback
200
0%
FMsealer
n = 10
100
LigaSure
n = 376
FMsealer
n = 476
LigaSure
n = 376
FMsealer
n = 476
LigaSure
12.4
Harmonic
Histologic analysis of comparative seals using a LigaSure laparoscopic vessel sealing instrument
(left), Harmonic laparoscopic vessel sealing instrument (middle), and FMsealer Laparoscopic Shears
(right) in porcine arteries. Black lines indicate measurements of thermal damage.
seconds
Internal data on file
†
FMX Power Modules connect FMX surgical
instruments to the generator, and intelligently
manage the communication throughout the system.
The FMX Ferromagnetic Surgical System
harnesses state-of-the-art technology to achieve
unparalleled simplicity. To prepare the FMX
system for use, follow these simple steps:
SD = .39
300
80%
2.5
2012 MDEA
Gold Award
Winner
FMX Surgical Instruments have been designed to
bring the unique clinical benefits of ferromagnetic
technology to a wide range of surgical sub-specialties.
SD = .34
1.80
mm
FMsealer
n = 33
846
1.4
Harmonic
n = 42
seconds
900
90%
86%
LigaSure
n = 10
1200
94%
88%
0.2
LigaSure
n = 63
1400
98%
Curved, non-stick jaws
can be rotated 340°
0.1
1500
100%
5 mm diameter shaft for use with
standard 5 mm trocars
0
FMX Generator features a patented
software control algorithm that
continuously monitors and
adjusts the delivery of
energy to the tissue,
ensuring that the
optimal amount of heat
is delivered at all times.
FMX Generator offers multi
language support through
its graphical user interface.
FMsealer
1
Plug the FMX Power Module into the
front panel of the FMX Generator
2
Snap the power module into
the back of the FMsealer
3
Set the MIN power setting on the
generator and the FMsealer is ready
Utilizing a single power module, multiple FMX
instruments can be swapped out at any time
during surgery. Simply remove the power
module and snap it into any another FMX
instrument. The generator remembers each
instrument’s previous power setting, making
the instrument swap fast and seamless.
The FMsealer sealed vessels with clinically reliable burst pressures consistent with other
technologies currently available. The FMsealer compared favorably with the other technologies
in speed and efficiency as well as tissue effects, including thermal spread and injury.
Chen J, Manwaring PK, Scott RR, Manwaring KH, Glasgow RE. Ferromagnetic Heating for Vessel Sealing and Division:
Utility and Comparative Study to Ultrasonic and Bipolar Technologies. Surgical Innovation. 2015.
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in laparoscopic and open procedures
Electrically silent operation, no
stray current, safe to use around
metal staples and clips
FMmin and FMmax activation modes
Patented active cooling system
ensures localization of heat in
the jaws and rapid cool down
Reliable Vessel Sealing
Speed and Efficiency
Minimal Thermal Injury
Vessel sealing reliability and burst pressure measurements are comparable
to LigaSure bipolar laparoscopic vessel sealing instruments†
No stray electrical current passes through the patient, no risk of
capacitive coupling, safe to use around metal staples and clips
Faster sealing and dividing cycles
than competitive instruments†
Dual activation modes put full control of
thermal effect in the hands of the surgeon
Pure thermal effect with less lateral thermal spread than LigaSure bipolar
and Harmonic ultrasonic laparoscopic vessel sealing instruments†
FMsealer Laparoscopic Shears are actively cooled, providing lower operating
temperatures than Harmonic ultrasonic laparoscopic vessel sealing instruments†
Sealing Reliability Analysis
Burst Pressure Analysis
Dissection Speed Test
Lateral Thermal Spread Analysis
Vessel sealing tests were performed using FMsealer
Laparoscopic Shears and LigaSure laparoscopic vessel
sealing instruments on porcine arteries ranging between
3 and 7 mm in diameter in a controlled laboratory
setting. The percentage of overall seals that resulted in
burst pressures above 240 mmHg, are shown below.†
Burst pressure comparisons were performed using FMsealer
Laparoscopic Shears and LigaSure laparoscopic vessel sealing
instruments on porcine arteries ranging between 3 and 7 mm
in diameter. Each vessel was sealed, divided, and pressurized
using an automated inflation system until the seal failed.
Average burst pressure results in mmHg are shown below.†
Speed tests were performed using FMsealer Laparoscopic
Shears, LigaSure, and Harmonic laparoscopic vessel sealing
instruments. A 10 cm section of porcine mesentery was
measured and marked prior to dissection. Each instrument was
used to seal and divide the pre-measured segments. Multiple
rounds were completed with each instrument, and the average
time to complete each 10 cm dissection is shown below.†
To determine lateral thermal spread, porcine arteries ranging between 4 and 5 mm in diameter were sealed and divided using FMsealer
Laparoscopic Shears, LigaSure, and Harmonic laparoscopic vessel sealing instruments. After sealing and dissection, each artery
was harvested. HE staining and histologic assessment of lateral thermal spread was performed by an independent reviewer. Lateral
thermal spread was determined to be the maximum distance thermal injury extends laterally from the edge of the instrument.†
1300
96%
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
Compatible with
reusable or disposable
FMX Power Modules
1100
92%
1000
30.0
0.3
1.3
90%
91%
success
success
800
700
600
mmHg
500
84%
400
82%
896
mmHg
SD =
Harmonic
n = 10
1.5
1.6
1.7
1.8
1.9
2.03
mm
1.68
mm
2.0
2.1
2.2
2.3
2.4
Seal Only Mode: Used to seal large vessels; > 2 mm in diameter*
FMsealer
activation
modes and
power settings
Pulsed audio tone indicating activation of vessel sealing cycle - followed by three short beeps indicating
completion of the cycle. If desired, FMmax button can be activated to divide the sealed vessel
SD = .43
26.8
seconds
350
SD = 402
Seal & Divide Mode: Used to seal & divide large vessels;
> 2 mm in diameter* with single button activation
Pulsed audio tone indicating activation of vessel sealing cycle - followed by continuous audio
tone indicating automatic transition to delivery of high power energy to divide the sealed vessel
High Power Seal & Divide Mode: Used to quickly seal & divide
vascular tissue bundles, membranes, and small vessels
Continuous audio tone indicating activation of high power energy to simultaneously
seal & divide tissue bundles, membranes, and small vessels
* Based on surgeon experiences and feedback
200
0%
FMsealer
n = 10
100
LigaSure
n = 376
FMsealer
n = 476
LigaSure
n = 376
FMsealer
n = 476
LigaSure
12.4
Harmonic
Histologic analysis of comparative seals using a LigaSure laparoscopic vessel sealing instrument
(left), Harmonic laparoscopic vessel sealing instrument (middle), and FMsealer Laparoscopic Shears
(right) in porcine arteries. Black lines indicate measurements of thermal damage.
seconds
Internal data on file
†
FMX Power Modules connect FMX surgical
instruments to the generator, and intelligently
manage the communication throughout the system.
The FMX Ferromagnetic Surgical System
harnesses state-of-the-art technology to achieve
unparalleled simplicity. To prepare the FMX
system for use, follow these simple steps:
SD = .39
300
80%
2.5
2012 MDEA
Gold Award
Winner
FMX Surgical Instruments have been designed to
bring the unique clinical benefits of ferromagnetic
technology to a wide range of surgical sub-specialties.
SD = .34
1.80
mm
FMsealer
n = 33
846
1.4
Harmonic
n = 42
seconds
900
90%
86%
LigaSure
n = 10
1200
94%
88%
0.2
LigaSure
n = 63
1400
98%
Curved, non-stick jaws
can be rotated 340°
0.1
1500
100%
5 mm diameter shaft for use with
standard 5 mm trocars
0
FMX Generator features a patented
software control algorithm that
continuously monitors and
adjusts the delivery of
energy to the tissue,
ensuring that the
optimal amount of heat
is delivered at all times.
FMX Generator offers multi
language support through
its graphical user interface.
FMsealer
1
Plug the FMX Power Module into the
front panel of the FMX Generator
2
Snap the power module into
the back of the FMsealer
3
Set the MIN power setting on the
generator and the FMsealer is ready
Utilizing a single power module, multiple FMX
instruments can be swapped out at any time
during surgery. Simply remove the power
module and snap it into any another FMX
instrument. The generator remembers each
instrument’s previous power setting, making
the instrument swap fast and seamless.
The FMsealer sealed vessels with clinically reliable burst pressures consistent with other
technologies currently available. The FMsealer compared favorably with the other technologies
in speed and efficiency as well as tissue effects, including thermal spread and injury.
Chen J, Manwaring PK, Scott RR, Manwaring KH, Glasgow RE. Ferromagnetic Heating for Vessel Sealing and Division:
Utility and Comparative Study to Ultrasonic and Bipolar Technologies. Surgical Innovation. 2015.
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in laparoscopic and open procedures
Electrically silent operation, no
stray current, safe to use around
metal staples and clips
FMmin and FMmax activation modes
Patented active cooling system
ensures localization of heat in
the jaws and rapid cool down
Reliable Vessel Sealing
Speed and Efficiency
Minimal Thermal Injury
Vessel sealing reliability and burst pressure measurements are comparable
to LigaSure bipolar laparoscopic vessel sealing instruments†
No stray electrical current passes through the patient, no risk of
capacitive coupling, safe to use around metal staples and clips
Faster sealing and dividing cycles
than competitive instruments†
Dual activation modes put full control of
thermal effect in the hands of the surgeon
Pure thermal effect with less lateral thermal spread than LigaSure bipolar
and Harmonic ultrasonic laparoscopic vessel sealing instruments†
FMsealer Laparoscopic Shears are actively cooled, providing lower operating
temperatures than Harmonic ultrasonic laparoscopic vessel sealing instruments†
Sealing Reliability Analysis
Burst Pressure Analysis
Dissection Speed Test
Lateral Thermal Spread Analysis
Vessel sealing tests were performed using FMsealer
Laparoscopic Shears and LigaSure laparoscopic vessel
sealing instruments on porcine arteries ranging between
3 and 7 mm in diameter in a controlled laboratory
setting. The percentage of overall seals that resulted in
burst pressures above 240 mmHg, are shown below.†
Burst pressure comparisons were performed using FMsealer
Laparoscopic Shears and LigaSure laparoscopic vessel sealing
instruments on porcine arteries ranging between 3 and 7 mm
in diameter. Each vessel was sealed, divided, and pressurized
using an automated inflation system until the seal failed.
Average burst pressure results in mmHg are shown below.†
Speed tests were performed using FMsealer Laparoscopic
Shears, LigaSure, and Harmonic laparoscopic vessel sealing
instruments. A 10 cm section of porcine mesentery was
measured and marked prior to dissection. Each instrument was
used to seal and divide the pre-measured segments. Multiple
rounds were completed with each instrument, and the average
time to complete each 10 cm dissection is shown below.†
To determine lateral thermal spread, porcine arteries ranging between 4 and 5 mm in diameter were sealed and divided using FMsealer
Laparoscopic Shears, LigaSure, and Harmonic laparoscopic vessel sealing instruments. After sealing and dissection, each artery
was harvested. HE staining and histologic assessment of lateral thermal spread was performed by an independent reviewer. Lateral
thermal spread was determined to be the maximum distance thermal injury extends laterally from the edge of the instrument.†
1300
96%
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
Compatible with
reusable or disposable
FMX Power Modules
1100
92%
1000
30.0
0.3
1.3
90%
91%
success
success
800
700
600
mmHg
500
84%
400
82%
896
mmHg
SD =
Harmonic
n = 10
1.5
1.6
1.7
1.8
1.9
2.03
mm
1.68
mm
2.0
2.1
2.2
2.3
2.4
Seal Only Mode: Used to seal large vessels; > 2 mm in diameter*
FMsealer
activation
modes and
power settings
Pulsed audio tone indicating activation of vessel sealing cycle - followed by three short beeps indicating
completion of the cycle. If desired, FMmax button can be activated to divide the sealed vessel
SD = .43
26.8
seconds
350
SD = 402
Seal & Divide Mode: Used to seal & divide large vessels;
> 2 mm in diameter* with single button activation
Pulsed audio tone indicating activation of vessel sealing cycle - followed by continuous audio
tone indicating automatic transition to delivery of high power energy to divide the sealed vessel
High Power Seal & Divide Mode: Used to quickly seal & divide
vascular tissue bundles, membranes, and small vessels
Continuous audio tone indicating activation of high power energy to simultaneously
seal & divide tissue bundles, membranes, and small vessels
* Based on surgeon experiences and feedback
200
0%
FMsealer
n = 10
100
LigaSure
n = 376
FMsealer
n = 476
LigaSure
n = 376
FMsealer
n = 476
LigaSure
12.4
Harmonic
Histologic analysis of comparative seals using a LigaSure laparoscopic vessel sealing instrument
(left), Harmonic laparoscopic vessel sealing instrument (middle), and FMsealer Laparoscopic Shears
(right) in porcine arteries. Black lines indicate measurements of thermal damage.
seconds
Internal data on file
†
FMX Power Modules connect FMX surgical
instruments to the generator, and intelligently
manage the communication throughout the system.
The FMX Ferromagnetic Surgical System
harnesses state-of-the-art technology to achieve
unparalleled simplicity. To prepare the FMX
system for use, follow these simple steps:
SD = .39
300
80%
2.5
2012 MDEA
Gold Award
Winner
FMX Surgical Instruments have been designed to
bring the unique clinical benefits of ferromagnetic
technology to a wide range of surgical sub-specialties.
SD = .34
1.80
mm
FMsealer
n = 33
846
1.4
Harmonic
n = 42
seconds
900
90%
86%
LigaSure
n = 10
1200
94%
88%
0.2
LigaSure
n = 63
1400
98%
Curved, non-stick jaws
can be rotated 340°
0.1
1500
100%
5 mm diameter shaft for use with
standard 5 mm trocars
0
FMX Generator features a patented
software control algorithm that
continuously monitors and
adjusts the delivery of
energy to the tissue,
ensuring that the
optimal amount of heat
is delivered at all times.
FMX Generator offers multi
language support through
its graphical user interface.
FMsealer
1
Plug the FMX Power Module into the
front panel of the FMX Generator
2
Snap the power module into
the back of the FMsealer
3
Set the MIN power setting on the
generator and the FMsealer is ready
Utilizing a single power module, multiple FMX
instruments can be swapped out at any time
during surgery. Simply remove the power
module and snap it into any other FMX
instrument. The generator remembers each
instrument’s previous power setting, making
the instrument swap fast and seamless.
FMsealer Laparoscopic Shears are an intelligent, multifunctional
thermal vessel sealing instrument that uses ferromagnetic technology
to efficiently seal and divide tissue with minimal lateral thermal
spread in laparoscopic and open surgical procedures.
Reliable sealing
of vessels up to
7 mm in diameter,
including lymphatics
Faster dissection
times than competitive
instruments through
vascular tissue bundles
Precise control of
heat, with less lateral
thermal spread than
competitive instruments
No stray electrical
current, no risk of
capacitive coupling,
safe to use around
metal staples and clips
Domain Surgical
1370 South 2100 East
Salt Lake City, UT 84108
(801) 924-4950
email: [email protected]
web: domainsurgical.com
FMsealer Laparoscopic Shears are a component
of the
Ferromagnetic Surgical System
To watch surgical videos of
FMX instruments in action, visit
domainsurgical.com/video
To learn how ferromagnetic
technology works, visit
domainsurgical.com/fmx
For additional information on the advantages and safety considerations of the FMX System, please visit domainsurgical.com.
For patent information, please visit domainsurgical.com/patent. © 2016 Domain Surgical, Inc. All rights reserved. LB-054 Rev. B
A multifunctional vessel sealing instrument that delivers
reliable sealing with precise control of thermal effect