Boston Scientific
Radiofrequency Ablation Systems
RF Ablation Needle Electrodes Proceedural Algorithms and Lesions Geometry Guide
Guide
13 Pages
Preview
Page 1
Procedural Algorithms and Lesion Geometry
Summary Liver & Kidney Protocols Soloist™ Single Needle Electrode 1.0cm Treatment Algorithm
1
Soloist™ Single Needle Electrode Lesion Geometry
2
™
3
™
LeVeen Needle Electrode Lesion Geometry
4
LeVeen™ Needle Electrode 3.0cm Treatment Algorithm
5
LeVeen™ Needle Electrode Lesion Geometry
6
LeVeen Needle Electrode 2.0cm Treatment Algorithm
™
7
™
LeVeen Needle Electrode Lesion Geometry
8
LeVeen™ Needle Electrode 4.0cm Treatment Algorithm
9
LeVeen™ Needle Electrode Lesion Geometry
10
LeVeen Needle Electrode 3.5cm Treatment Algorithm
™
11
™
12
LeVeen Needle Electrode 5.0cm Treatment Algorithm LeVeen Needle Electrode Lesion Geometry
Lung Protocols LeVeen™ Needle Electrode 2.0cm Treatment Algorithm ™
13
LeVeen Needle Electrode 3.0cm Treatment Algorithm
14
LeVeen™ Needle Electrode 3.5cm Treatment Algorithm
15
LeVeen™ Needle Electrode 4.0cm Treatment Algorithm
16
Ordering Information Radiofrequency Ablation Needle Electrodes
18
Introduce Soloist™ device into tissue with or without CoAccess™ Cannula
Check needle position to verify if still in target tissue.
Start treatment. Set RF Power at 2W
At 1 minute mark, if, power is under 3W, increase to 3W.
At 2 minute mark, if, power is under 4W, increase to 4W.
Continue to increase power at 1W per min. Refer toTarget Power table for recommended minimum setting during Ramp Up period. Total time of treatment; 0-4 minutes
Stop treatment.
No Roll-Off indication Auto stop after 15 minutes Time to Roll-Off indication
Treatment Time Point (min:sec)
Target Power During Ramp Up (Watts)
0:00
2
1:00
3
2:00
4
3:00
5
4:00
6
5:00
7
6:00
8
7:00
9
8:00
10
9:00
11
10:00
12
11:00
13
12:00
14
13:00
15
14:00
16
15:00
17
Soloist™ Single Needle Electrode Lesion Geometry*
Liver & Kidney Protocols
Liver & Kidney Protocols
Soloist™ Single Needle Electrode 1.0cm Treatment Algorithm
1.0
2.0
3.0
3mm
3.5 1.5cm
4.0 3mm
Relocate 0.5 cm. Restart at 70% of highest set power. Increase 1W per minute
5.0
> 4-15 minutes
Stop and wait approx. 30-60 seconds. Phase 2: Restart in place at approx. 70% of highest set power (i.e. 10W = 7W).
If 5 minute mark reached, increase power by 1 Watt every minute
Continue treatment until Roll-Off indication
Roll-Off ® Indication Power 70% (Watts) Watts
2
2
3
2
4
3
5
4
6
4
7
5
8
6
9
6
10
7
11
8
12
8
1cm
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
1
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
*These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types.
2
50
35
60
42
3.0
After 5 minutes increase power 10W per minute to 60W and maintain
Roll-Off Indication before 5 minutes?
Pause for 30 seconds and restart power at 70% of Roll-Off Indication power
No
3.5
Maintain 60W of power
1.0cm
Yes
4mm
Start treatment: Set Radiofrequency (RF) power to 30W. Increase 10W per minute to 60W, maintain until 5 minutes
Pause for 30 seconds and restart power at 50% of Roll-Off Indication power
1.0
2.0
Roll-Off ® Indication Power 70%
Deploy 2.0cm (20mm) LeVeen Electrode
Liver & Kidney Protocols
LeVeen™ Needle Electrode Lesion Geometry*
Yes
Roll-Off Indication before 15 minutes?
No
Immediately restart at 60W
1.5cm
Liver & Kidney Protocols
LeVeen™ Needle Electrode 2.0cm Treatment Algorithm
4.0
5.0 2.0cm
Continue treatment until Roll-Off Indication
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
3
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
*These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types.
4
Roll-Off Indication before 5 minutes?
No
60
42
70
49
80
56
90
63
100
70
110
77
120
84
130
91
140
98
150
105
1.0
2.0
3.0
3.5
Increase 10W per 30 seconds to 150W
2.5cm
Yes
35
1.6cm
Start treatment: Set Radiofrequency (RF) power to 40W. Increase 10W per 30 seconds to 80W, maintain until 5 minutes
50
Liver & Kidney Protocols
Roll-Off® Indication 70% Power
Deploy 3.0cm (30mm) LeVeen Electrode
Pause for 30 seconds and restart power at 50% of Roll-Off Indication power
LeVeen™ Needle Electrode Lesion Geometry*
5mm
Liver & Kidney Protocols
LeVeen™ Needle Electrode 3.0cm Treatment Algorithm
4.0
5.0 After 5 minutes increase power 10W per 30 seconds to 150W and maintain
Pause for 30 seconds and restart power at 70% of Roll-Off Indication power
Yes
Roll-Off Indication before 15 minutes?
No
Immediately restart at 150W
3.0cm
Continue treatment until Roll-Off Indication
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
5
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
*These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types.
6
No
Increase power 10W per 30 seconds to 180W
60
42
70
49
80
56
90
63
100
70
110
77
120
84
130
91
140
98
150
105
160
112
170
119
180
126
1.0
2.0
3.0
3.5 3.0cm
Yes
Roll-Off Indication before 5 minutes?
35
1.9cm
Start treatment: Set Radiofrequency (RF) power to 50W. Increase 10W per 30 seconds to 90W, maintain until 5 minutes
50
Liver & Kidney Protocols
Roll-Off® Indication Power 70%
Deploy 3.5cm (35mm) LeVeen Electrode
Pause for 30 seconds and restart power at 50% of Roll-Off Indication power
LeVeen™ Needle Electrode Lesion Geometry*
5mm
Liver & Kidney Protocols
LeVeen™ Needle Electrode 3.5cm Treatment Algorithm
4.0
5.0 After 5 minutes increase power 10W per 30 seconds to 180W and maintain
Pause for 30 seconds and restart power at 70% of Roll-Off Indication power
Yes
Roll-Off Indication before 15 minutes?
No
Immediately restart at 180W
3.5cm Continue treatment until Roll-Off Indication
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
7
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
*These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types.
8
Roll-Off Indication before 5 minutes?
No
Increase power 10W per 30 seconds to 190W
60
42
70
49
80
56
90
63
100
70
110
77
120
84
130
91
140
98
150
105
160
112
170
119
180
126
190
133
2.0
3.0
3.5 3.3cm
Yes
35
2.2cm
Start treatment: Set Radiofrequency (RF) power to 80W. Increase 10W per 30 seconds to 130W, maintain until 5 minutes
50
1.0
Liver & Kidney Protocols
Roll-Off® Indication Power 70%
Deploy 4.0cm (40mm) LeVeen Electrode
Pause for 30 seconds and restart power at 50% of Roll-Off Indication power
LeVeen™ Needle Electrode Lesion Geometry*
7mm
Liver & Kidney Protocols
LeVeen™ Needle Electrode 4.0cm Treatment Algorithm
4.0
5.0 After 5 minutes increase power 10W per 30 seconds to 190W and maintain
Pause for 30 seconds and restart power at 70% of Roll-Off Indication power
Yes
Roll-Off Indication before 15 minutes?
No
Immediately restart at 190W
4.0cm
Continue treatment until Roll-Off Indication
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
9
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
*These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types.
10
After 5 minutes increase power 10W per 30 seconds to 200W and maintain
Yes
No
Roll-Off Indication before 5 minutes?
Pause for 30 seconds and restart power at 70% of Roll-Off Indication power
Yes
Increase power 10W per 30 seconds to 200W
Impedance rise before 15 minutes?
No
42
70
49
80
56
90
63
100
70
110
77
120
84
130
91
140
98
150
105
160
112
170
119
180
126
190
133
200
140
Roll-Off Indication before 20 minutes?
3.0
Retract array to marking on handle, reinsert blue retention clip, and reset generator power to 130W
Hold until a 5 ohm increase occurs. Fully deploy array. After 30 seconds, increase power 10W per 30 seconds to 200W.
Yes
2.0
3.5 3.0cm
Start treatment: Set Radiofrequency (RF) power to 100W. Increase 10W per 30 seconds to 150W, maintain until 5 minutes
35
60
2.0cm
Fully deploy the 5.0cm (50mm) array
50
1.0
Liver & Kidney Protocols
Roll-Off® Indication Power 70%
Preset the time on the RF 3000™ Generator to 20 minutes
Pause for 30 seconds and restart power at 50% of Roll-Off Indication power
LeVeen™ Needle Electrode Lesion Geometry*
1.0cm
Liver & Kidney Protocols
LeVeen™ Needle Electrode 5.0cm Treatment Algorithm
4.0
5.0 5.0cm
No Immediately restart at 200W
Continue treatment until Roll-Off Indication
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
11
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
*These diagrams provide estimated lesion geometry. They are to be used as guides only. Parameters may change based on user modifications to treatment, location of needle placement and variables of individual tissue types.
12
Deploy fully 2.0 (20 mm) Le Veen™ Electrode
Deploy fully 3.0 (30 mm) Le Veen™ Electrode
0%
0%
> 25 %
Pleural Contact
Start treatment: Set radiofrequency power (RF) to 10 W. Increase 5 W per minute
Yes
Roll-Off before 15 minutes
No
Start treatment: Set radiofrequency power (RF) to 20 W. Increase 10 W per minute
Start treatment: Set radiofrequency power (RF) to 10 W. Increase 10 W per minute
Start treatment: Set radiofrequency power (RF) to 20 W. Increase 10 W per minute
Yes
Restart et last RF power before automatic shut off
Roll-Off before 15 minutes
P.C = 0% : increase 5 W per 3 minutes P.C < 25% : increase 5 W per minute P.C > 25% : increase 10 W per minute
Continue treatment until Roll-Off
Continue treatment until Roll-Off
Treatment Complete
13
No
Start treatment: Set radiofrequency power (RF) to 30 W. Increase 10 W per minute
Restart et last RF power before automatic shut off
P.C = 0% : increase 10 W per minute P.C < 25% : increase 10 W per minute P.C > 25% : increase 10 W per minute
P.C = 0% : increase 5 W per 3 minutes P.C < 25% : increase 5 W per minute P.C > 25% : increase 10 W per minute
Pause for 30 secondes and restart power at 70 % of Roll-Off power
> 25 %
Pleural Contact
> 25 %
> 25 % Start treatment: Set radiofrequency power (RF) to 5 W. Increase 5 W per 3 minutes
Lung Protocols
LeVeen™ Needle Electrode 3.0cm Treatment Algorithm
Lung Protocols
LeVeen™ Needle Electrode 2.0cm Treatment Algorithm
Pause for 30 secondes and restart power at 70 % of Roll-Off power P.C = 0% : increase 10 W per minute P.C < 25% : increase 10 W per minute P.C > 25% : increase 10 W per minute
Continue treatment until Roll-Off
Continue treatment until Roll-Off
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
14
Deploy fully 3.5 (35 mm) Le Veen™ Electrode
Deploy fully 4.0 (40 mm) Le Veen™ Electrode
0%
0%
> 25 %
Pleural Contact
Start treatment: Set radiofrequency power (RF) to 30 W. Increase 10 W per minute
Yes
Roll-Off before 15 minutes
No
Start treatment: Set radiofrequency power (RF) to 40 W. Increase 10 W per minute
Start treatment: Set radiofrequency power (RF) to 30 W. Increase 10 W per minute
Start treatment: Set radiofrequency power (RF) to 40 W. Increase 10 W per minute
Yes
Restart et last RF power before automatic shut off
Roll-Off before 15 minutes
P.C = 0% : increase 10 W per minute P.C < 25% : increase 10 W per minute P.C > 25% : increase 10 W per minute
Continue treatment until Roll-Off
Continue treatment until Roll-Off
Treatment Complete
15
No
Start treatment: Set radiofrequency power (RF) to 50 W. Increase 10 W per minute
Restart et last RF power before automatic shut off
P.C = 0% : increase 10 W per minute P.C < 25% : increase 10 W per minute P.C > 25% : increase 10 W per minute
P.C = 0% : increase 10 W per minute P.C < 25% : increase 10 W per minute P.C > 25% : increase 10 W per minute
Pause for 30 secondes and restart power at 70 % of Roll-Off power
> 25 %
Pleural Contact
> 25 %
> 25 % Start treatment: Set radiofrequency power (RF) to 20 W. Increase 10 W per minute
Lung Protocols
LeVeen™ Needle Electrode 4.0cm Treatment Algorithm
Lung Protocols
LeVeen™ Needle Electrode 3.5cm Treatment Algorithm
Pause for 30 secondes and restart power at 70 % of Roll-Off power P.C = 0% : increase 10 W per minute P.C < 25% : increase 10 W per minute P.C > 25% : increase 10 W per minute
Continue treatment until Roll-Off
Continue treatment until Roll-Off
Treatment Complete
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
The RF energy should be applied until a rise in impedance and corresponding drop in delivered power (Roll-Off Indication) is achieved. This condition indicates that tissue coagulation has occurred around all elements of the wire array. It is important that the time to Roll-Off Indication is at least 4 minutes in order to ensure conduction of heat throughout the target zone. Roll-Off Indication that occurs too quickly indicates that the heating rate may have been too rapid and an undersized thermal lesion may result.
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
NOTE: These algorithms have been provided as guides and for information purposes only. Treatment parameters may be modified according to user experience and the thermal requirements of individual tissue types. Always refer to the Directions for Use for the most current guidance/indications. Not a diagnostic or treatment referral tool.
16
Radiofrequency Ablation Needle Electrodes ORDERING INFORMATION UPN
Order Number
Array Diameter
Cannula Length (cm)
5.0 5.0 4.0 4.0 3.5 3.5 3.5 3.0 3.0
25 15 25 15 12 15 25 12 15
3.0 3.0 2.0 2.0
25 15 25 15
LeVeen™ Needle Electrodes
WARNING The 2 arrows to the left (shown in blue on this illustration) measure the distance between the base of the umbrella and the top of the tines.
M001262170 M001262160 M001262310 M001262130 M001262020 M001262030 M001262150 M001262040 M001262050
26-217 26-216 26-231 26-213 26-202 26-203 26-215 26-204 26-205
LeVeen™ SuperSlim™ Needle Electrodes top of tines
M001262290 M001262280 M001262270 M001262260
26-229 26-228 26-227 26-226
base of umbrella
LeVeen™ CoAccess™ Needle Electrode System M001262240 M001262230 M001262220
26-224 26-223 26-222
4.0 3.5 3.0
15 15 15
Active Electrode Length (cm) 0.9
18
Soloist™ Single Needle Electrode M001262500
17
26-250
18
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