Multifunctional vessel sealing devices that deliver

are intelligent, multifunctional thermal vessel
sealing devices that use ferromagnetic technology to precisely
seal and divide tissue with minimal lateral thermal spread
in both open and laparoscopic surgical procedures.
Domain Surgical
1370 South 2100 East
Salt Lake City, UT 84108
(801) 924-4950
email: [email protected]
web: domainsurgical.com
Reliable sealing
of vessels up to
7 mm in diameter,
including lymphatics
Minimal thermal
spread, no stray
current, safe around
metal staples & clips
Quick and efficient
operation with single
action seal and divide
or seal-only modes
To watch surgical videos
of FMX tools in action, visit
domainsurgical.com/video
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. © 2015 Domain Surgical, Inc. All rights reserved. LB-053 Rev. A
A Component of the
Ferromagnetic Surgical System
Multifunctional vessel sealing devices that deliver
reliable sealing with precise control of thermal effect.
are intelligent, multifunctional thermal vessel
sealing devices that use ferromagnetic technology to precisely
seal and divide tissue with minimal lateral thermal spread
in both open and laparoscopic surgical procedures.
Domain Surgical
1370 South 2100 East
Salt Lake City, UT 84108
(801) 924-4950
email: [email protected]
web: domainsurgical.com
Reliable sealing
of vessels up to
7 mm in diameter,
including lymphatics
Minimal thermal
spread, no stray
current, safe around
metal staples & clips
Quick and efficient
operation with single
action seal and divide
or seal-only modes
To watch surgical videos
of FMX tools in action, visit
domainsurgical.com/video
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. © 2015 Domain Surgical, Inc. All rights reserved. LB-053 Rev. A
A Component of the
Ferromagnetic Surgical System
Multifunctional vessel sealing devices that deliver
reliable sealing with precise control of thermal effect.
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in laparoscopic and open procedures
MAX and MIN
activation modes
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in open procedures
Electrically silent operation, no
stray current, safe to use around
metal staples and clips
Patented active cooling system
ensures localization of heat in
the jaws, and rapid cool down
Electrically silent operation,
no stray current, safe
to use around metal
staples and clips
Compatible with reusable
or disposable FMX
Power Modules
5 mm diameter shaft for use with
standard 5 mm trocars
MAX and MIN activation modes
Patented active cooling system
ensures localization of heat in
the jaws and rapid cool down
Compatible with reusable or
disposable FMX Power Modules
Reliable Vessel Sealing
Minimal Thermal Injury
Speed and Efficiency
Compared to LigaSure™ bipolar
devices, the current industry standard
for vessel sealing reliability.
Compared to Harmonic ultrasonic
devices, the current industry standard
for minimized collateral thermal injury.
Compared to both LigaSure and
Harmonic vessel sealing devices.
Vessel sealing reliability comparable
to LigaSure bipolar devices*
Burst pressure measurements
comparable to LigaSure devices*
No stray electrical current, no risk
of capacitive coupling, safe to use
around metal staples and clips
®
Pure thermal effect with less
lateral thermal spread than
Harmonic ultrasonic devices**
FMsealers are actively cooled,
providing lower operating
temperatures than Harmonic devices*
Open Devices
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
Laparoscopic Devices
LigaSure
FMsealer
LigaSure
FMsealer
Vessel Sealing Reliability - percentage of sealed
vessels (between 2 and 7 mm in diameter) that
resulted in burst pressures greater than 240 mmHg
93%
93%
95%
97%
Average Burst Pressure - average burst pressure in
mmHg of sealed vessels (between 2 and 7 mm in diameter)
838
853
1012
1079
Harmonic
FMsealer
Harmonic
FMsealer
Lateral Thermal Spread - Lateral thermal spread
(in mm) in vessels as measured by histology
1.76
1.51
2.03
1.68
Speed and Efficiency - average time to seal
and divide 10 cm of porcine mesentery
26.8
13.0
26.8
12.4
Curved, non-stick jaws
can be rotated 340°
Curved, non-stick jaws are over
30% longer than Harmonic Focus®
and LigaSure™ small jaw
Faster sealing and dividing cycles
than competitive devices**
Efficient hemostatic dissection
of vascular tissue bundles
Dual activation modes put control
in the hands of the surgeon
success
mmHg
mm
seconds
success
mmHg
mm
seconds
success
mmHg
mm
seconds
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
LigaSure
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:
1
Plug the power
module into the front
of the generator
2
Snap the power
module into the rear
of the FMsealer
3
Set power on the
generator and the
FMsealer is ready for use
FMsealer
dual activation
modes
mode is used to quickly transect through
vascular tissue bundles and small vessels.
A steady audible tone indicates the MAX mode is activated. MAX mode simultaneously
seals and divides tissue bundles and small vessels in a single action.
mode is used to reliably seal larger vessels,
with the option to seal a vessel without dividing.
A pulsing audible tone indicates the MIN mode is activated. When the vessel sealing cycle is finished, the
speed of the pulsing tone increases. At this point the surgeon has the option to release the button - which
leaves the vessel sealed, but not divided - or to keep the button activated and automatically divide the vessel.
Harmonic
success
FMsealer
mmHg
mm
seconds
Histologic analysis of
comparative seals using
the LigaSure 5 mm
blunt tip (left), Harmonic
Ace (middle), and
FMsealer Laparoscopic
Shears (right) in porcine
arteries. Black lines
indicate measurements
of thermal damage.
FMsealers provide extremely reliable and consistent vessel sealing.
FMsealers also performed faster than competitive devices in sealing and
dividing vascular tissue, with the least amount of lateral thermal 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.
** Internal data on file
FMX Generator:
The 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.
2012 MDEA
Gold Award
Winner
FMX Power Modules:
Connect FMX surgical tools
to the generator, and intelligently manage
the communication throughout the system.
FMX Surgical Tools:
A variety of surgical tools have been
designed to bring the unique clinical
benefits of ferromagnetic technology to a
broad array of surgical sub-specialties.
How does ferromagnetic
surgical technology work?
1
The active surface of each FMX surgical tool
is plated with a thin ferromagnetic coating.
2
As the tool is activated, the FMX
generator passes electrical energy
through the ferromagnetic coating
and back to the generator, creating a
rapidly alternating magnetic field.
3
The coating instantly reacts to the alternating
magnetic field, producing uniform heat
throughout the coated area. When in
contact with tissue, this uniform heat
precisely cuts, coagulates, and seals with
minimal collateral thermal injury. When
deactivated, the coating cools quickly.
4
FMX surgical tools are electrically silent. The
energy delivered to the tool returns to ground
through the generator and does not pass
through the tissue. The energy also does
not radiate and interfere with intraoperative
monitoring or implanted electronic devices.
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in laparoscopic and open procedures
MAX and MIN
activation modes
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in open procedures
Electrically silent operation, no
stray current, safe to use around
metal staples and clips
Patented active cooling system
ensures localization of heat in
the jaws, and rapid cool down
Electrically silent operation,
no stray current, safe
to use around metal
staples and clips
Compatible with reusable
or disposable FMX
Power Modules
5 mm diameter shaft for use with
standard 5 mm trocars
MAX and MIN activation modes
Patented active cooling system
ensures localization of heat in
the jaws and rapid cool down
Compatible with reusable or
disposable FMX Power Modules
Reliable Vessel Sealing
Minimal Thermal Injury
Speed and Efficiency
Compared to LigaSure™ bipolar
devices, the current industry standard
for vessel sealing reliability.
Compared to Harmonic ultrasonic
devices, the current industry standard
for minimized collateral thermal injury.
Compared to both LigaSure and
Harmonic vessel sealing devices.
Vessel sealing reliability comparable
to LigaSure bipolar devices*
Burst pressure measurements
comparable to LigaSure devices*
No stray electrical current, no risk
of capacitive coupling, safe to use
around metal staples and clips
®
Pure thermal effect with less
lateral thermal spread than
Harmonic ultrasonic devices**
FMsealers are actively cooled,
providing lower operating
temperatures than Harmonic devices*
Open Devices
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
Laparoscopic Devices
LigaSure
FMsealer
LigaSure
FMsealer
Vessel Sealing Reliability - percentage of sealed
vessels (between 2 and 7 mm in diameter) that
resulted in burst pressures greater than 240 mmHg
93%
93%
95%
97%
Average Burst Pressure - average burst pressure in
mmHg of sealed vessels (between 2 and 7 mm in diameter)
838
853
1012
1079
Harmonic
FMsealer
Harmonic
FMsealer
Lateral Thermal Spread - Lateral thermal spread
(in mm) in vessels as measured by histology
1.76
1.51
2.03
1.68
Speed and Efficiency - average time to seal
and divide 10 cm of porcine mesentery
26.8
13.0
26.8
12.4
Curved, non-stick jaws
can be rotated 340°
Curved, non-stick jaws are over
30% longer than Harmonic Focus®
and LigaSure™ small jaw
Faster sealing and dividing cycles
than competitive devices**
Efficient hemostatic dissection
of vascular tissue bundles
Dual activation modes put control
in the hands of the surgeon
success
mmHg
mm
seconds
success
mmHg
mm
seconds
success
mmHg
mm
seconds
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
LigaSure
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:
1
Plug the power
module into the front
of the generator
2
Snap the power
module into the rear
of the FMsealer
3
Set power on the
generator and the
FMsealer is ready for use
FMsealer
dual activation
modes
mode is used to quickly transect through
vascular tissue bundles and small vessels.
A steady audible tone indicates the MAX mode is activated. MAX mode simultaneously
seals and divides tissue bundles and small vessels in a single action.
mode is used to reliably seal larger vessels,
with the option to seal a vessel without dividing.
A pulsing audible tone indicates the MIN mode is activated. When the vessel sealing cycle is finished, the
speed of the pulsing tone increases. At this point the surgeon has the option to release the button - which
leaves the vessel sealed, but not divided - or to keep the button activated and automatically divide the vessel.
Harmonic
success
FMsealer
mmHg
mm
seconds
Histologic analysis of
comparative seals using
the LigaSure 5 mm
blunt tip (left), Harmonic
Ace (middle), and
FMsealer Laparoscopic
Shears (right) in porcine
arteries. Black lines
indicate measurements
of thermal damage.
FMsealers provide extremely reliable and consistent vessel sealing.
FMsealers also performed faster than competitive devices in sealing and
dividing vascular tissue, with the least amount of lateral thermal 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.
** Internal data on file
FMX Generator:
The 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.
2012 MDEA
Gold Award
Winner
FMX Power Modules:
Connect FMX surgical tools
to the generator, and intelligently manage
the communication throughout the system.
FMX Surgical Tools:
A variety of surgical tools have been
designed to bring the unique clinical
benefits of ferromagnetic technology to a
broad array of surgical sub-specialties.
How does ferromagnetic
surgical technology work?
1
The active surface of each FMX surgical tool
is plated with a thin ferromagnetic coating.
2
As the tool is activated, the FMX
generator passes electrical energy
through the ferromagnetic coating
and back to the generator, creating a
rapidly alternating magnetic field.
3
The coating instantly reacts to the alternating
magnetic field, producing uniform heat
throughout the coated area. When in
contact with tissue, this uniform heat
precisely cuts, coagulates, and seals with
minimal collateral thermal injury. When
deactivated, the coating cools quickly.
4
FMX surgical tools are electrically silent. The
energy delivered to the tool returns to ground
through the generator and does not pass
through the tissue. The energy also does
not radiate and interfere with intraoperative
monitoring or implanted electronic devices.
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in laparoscopic and open procedures
MAX and MIN
activation modes
Indicated for sealing vessels up to 7 mm
in diameter, including lymphatics,
in open procedures
Electrically silent operation, no
stray current, safe to use around
metal staples and clips
Patented active cooling system
ensures localization of heat in
the jaws, and rapid cool down
Electrically silent operation,
no stray current, safe
to use around metal
staples and clips
Compatible with reusable
or disposable FMX
Power Modules
5 mm diameter shaft for use with
standard 5 mm trocars
MAX and MIN activation modes
Patented active cooling system
ensures localization of heat in
the jaws and rapid cool down
Compatible with reusable or
disposable FMX Power Modules
Reliable Vessel Sealing
Minimal Thermal Injury
Speed and Efficiency
Compared to LigaSure™ bipolar
devices, the current industry standard
for vessel sealing reliability.
Compared to Harmonic ultrasonic
devices, the current industry standard
for minimized collateral thermal injury.
Compared to both LigaSure and
Harmonic vessel sealing devices.
Vessel sealing reliability comparable
to LigaSure bipolar devices*
Burst pressure measurements
comparable to LigaSure devices*
No stray electrical current, no risk
of capacitive coupling, safe to use
around metal staples and clips
®
Pure thermal effect with less
lateral thermal spread than
Harmonic ultrasonic devices**
FMsealers are actively cooled,
providing lower operating
temperatures than Harmonic devices*
Open Devices
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
Laparoscopic Devices
LigaSure
FMsealer
LigaSure
FMsealer
Vessel Sealing Reliability - percentage of sealed
vessels (between 2 and 7 mm in diameter) that
resulted in burst pressures greater than 240 mmHg
93%
93%
95%
97%
Average Burst Pressure - average burst pressure in
mmHg of sealed vessels (between 2 and 7 mm in diameter)
838
853
1012
1079
Harmonic
FMsealer
Harmonic
FMsealer
Lateral Thermal Spread - Lateral thermal spread
(in mm) in vessels as measured by histology
1.76
1.51
2.03
1.68
Speed and Efficiency - average time to seal
and divide 10 cm of porcine mesentery
26.8
13.0
26.8
12.4
Curved, non-stick jaws
can be rotated 340°
Curved, non-stick jaws are over
30% longer than Harmonic Focus®
and LigaSure™ small jaw
Faster sealing and dividing cycles
than competitive devices**
Efficient hemostatic dissection
of vascular tissue bundles
Dual activation modes put control
in the hands of the surgeon
success
mmHg
mm
seconds
success
mmHg
mm
seconds
success
mmHg
mm
seconds
Ferromagnetic heating can be
activated while compressing
the jaws to seal and divide
vascular tissue bundles
LigaSure
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:
1
Plug the power
module into the front
of the generator
2
Snap the power
module into the rear
of the FMsealer
3
Set power on the
generator and the
FMsealer is ready for use
FMsealer
dual activation
modes
mode is used to quickly transect through
vascular tissue bundles and small vessels.
A steady audible tone indicates the MAX mode is activated. MAX mode simultaneously
seals and divides tissue bundles and small vessels in a single action.
mode is used to reliably seal larger vessels,
with the option to seal a vessel without dividing.
A pulsing audible tone indicates the MIN mode is activated. When the vessel sealing cycle is finished, the
speed of the pulsing tone increases. At this point the surgeon has the option to release the button - which
leaves the vessel sealed, but not divided - or to keep the button activated and automatically divide the vessel.
Harmonic
success
FMsealer
mmHg
mm
seconds
Histologic analysis of
comparative seals using
the LigaSure 5 mm
blunt tip (left), Harmonic
Ace (middle), and
FMsealer Laparoscopic
Shears (right) in porcine
arteries. Black lines
indicate measurements
of thermal damage.
FMsealers provide extremely reliable and consistent vessel sealing.
FMsealers also performed faster than competitive devices in sealing and
dividing vascular tissue, with the least amount of lateral thermal 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.
** Internal data on file
FMX Generator:
The 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.
2012 MDEA
Gold Award
Winner
FMX Power Modules:
Connect FMX surgical tools
to the generator, and intelligently manage
the communication throughout the system.
FMX Surgical Tools:
A variety of surgical tools have been
designed to bring the unique clinical
benefits of ferromagnetic technology to a
broad array of surgical sub-specialties.
How does ferromagnetic
surgical technology work?
1
The active surface of each FMX surgical tool
is plated with a thin ferromagnetic coating.
2
As the tool is activated, the FMX
generator passes electrical energy
through the ferromagnetic coating
and back to the generator, creating a
rapidly alternating magnetic field.
3
The coating instantly reacts to the alternating
magnetic field, producing uniform heat
throughout the coated area. When in
contact with tissue, this uniform heat
precisely cuts, coagulates, and seals with
minimal collateral thermal injury. When
deactivated, the coating cools quickly.
4
FMX surgical tools are electrically silent. The
energy delivered to the tool returns to ground
through the generator and does not pass
through the tissue. The energy also does
not radiate and interfere with intraoperative
monitoring or implanted electronic devices.
are intelligent, multifunctional thermal vessel
sealing devices that use ferromagnetic technology to precisely
seal and divide tissue with minimal lateral thermal spread
in both open and laparoscopic surgical procedures.
Domain Surgical
1370 South 2100 East
Salt Lake City, UT 84108
(801) 924-4950
email: [email protected]
web: domainsurgical.com
Reliable sealing
of vessels up to
7 mm in diameter,
including lymphatics
Minimal thermal
spread, no stray
current, safe around
metal staples & clips
Quick and efficient
operation with single
action seal and divide
or seal-only modes
To watch surgical videos
of FMX tools in action, visit
domainsurgical.com/video
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. © 2015 Domain Surgical, Inc. All rights reserved. LB-053 Rev. A
A Component of the
Ferromagnetic Surgical System
Multifunctional vessel sealing devices that deliver
reliable sealing with precise control of thermal effect.