PEAK Plasma Blade Pacemaker ICD Brochure

2013-06-18

: Pdf Peak Plasmablade Pacemaker-Icd Brochure PEAK_PlasmaBlade_Pacemaker-ICD_Brochure 6 2013 pdf

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PEAK PlasmaBlade™ for
Pacemaker/ICD
Implants and Revisions
The PEAK PlasmaBlade: Pacemaker/ICD Implants and Revisions
Selected References*
1. Loh SA, Carlson GA, Chang EI et al. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery and a scalpel. Plas
Reconstr Surg 2009; 124(6):1849-1859. Chronic wound healing study conducted in living porcine model.
2. Data on file. ETR-00023.
3. Ruidiaz ME, Messmer D, Huang EJ et al. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery,
and a standard scalpel. Plas Reconstr Surg 2011; 128(1): 104-111. Chronic wound healing study conducted in subjects undergoing abdominoplasty.
4. Chang E, Carlson GA, Vose JG, et al. Comparative healing of rat fascia following incision with three surgical instruments. J Surg Res 2011; 167:e47-e54.
5. Data on le. VR-0055.
6. Weisberg IL, Desai S, Davison P et al. Effects of pulsed RF energy compared to standard electrosurgery on transvenous lead insulation materials. Heart Rhythm
Society Annual Meeting 2010. Denver, Colorado.
7. Lim K, Reddy S, Desai S et al. Effects of electrocautery on transvenous lead insulation materials. J Cardiovasc Electrophysiol 2009; 20(4):429-435.
8. Reynolds MR, Cohen DJ, Kugelmass AD et al. The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable
cardioverter-defibrillators. J Am Coll Cardiol 2006; 47:2493-2497.
* Performance has not been specifically established in all surgical procedures.
Conclusion
Use of the PEAK PlasmaBlade for pacemaker/ICD
implants and revisions may reduce the likelihood of
transvenous lead damage compared to traditional
electrosurgery. Although the overall risk of
transvenous lead injury is relatively low, the patient
and nancial consequences are serious and the use
of additional measures to reduce potential risk, such
as the PEAK PlasmaBlade, should be considered.
Copolymer lead, perpendicular device orientation, cut mode
Traditional ESU: 30 WattsPEAK PlasmaBlade: Setting 5
© 2013 Medtronic Advanced Energy LLC. All rights reserved. Printed in USA. PEAK, PEAK PlasmaBlade and PULSAR
are registered and/or trademarks of Medtronic Advanced Energy LLC. U.S. Patent Nos. 6,135,998, 6,913,605, 6,730,075,
6,780,178, 7,238,185, 7,357,802, 7,736,361, and 7,789,879. Additional patents pending.
71-10-2400 4.13 Rev B
Rx only. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions For Use (IFU) that accompany PEAK PlasmaBlade disposable devices and/or the
PEAK Surgery System User Guide.
Medtronic Advanced Energy LLC
180 International Drive
Portsmouth, NH 03801
USA
www.medtronicadvancedenergy.com
Tel: (866) 777-9400
Fax: (866) 222-0900
For further information, please call 866-777-9400 or 603-742-1515.
You may also consult our website:
www.medtronicadvancedenergy.com
International Telephone Numbers
Adriatic Regional Oce 385-1-488-1120
Australia 1800-668-670
Baltic Regional Oce 37-1-67560226
Belgium 32-2456-09-09
Canada 1800-217-1617
China 86-21-50800998
Czech Republic 420-2-9657-9580
France 33-470-679-800
Germany 49-2159-8149-209
Greece 30-210-67-79-099
Hong Kong 852-2919-1312
Hungary 36-30-5052987
India 91-22-26836733
Israel 972-9-972-4400
Italy 39-02-24137-324
Japan 81-6-4795-1506
Korea 82-2-3404-3600
Lebanon 961-1-370-670
Luxembourg 32-2456-09-09
Netherlands 31-45-566-8800
Poland 48-22-465-6942
Russian Federation 7-495-580-73-77
Singapore 65-6776-6255
South Africa 27-11-466-1820
Spain 34-91-625-05-40
Taiwan 886-2-2183-6000
UK 44-1923-205-166
USA 1-603-742-1515
The PEAK PlasmaBlade: Pacemaker Generator and Battery Replacement
Scalpel
PEAK PlasmaBlade Cut
Electrosurgery Cut
Thermal Injury Profile1
Device Effect on Transvenous Lead Insulation
The PEAK PlasmaBlade: Pacemaker/ICD Implants and Revisions
Damage Score:
0 - none, 3 - severe
Polyurethane Copolymer Silicone
PARALLEL
AT SETTING 5
PARALLEL
AT SETTING 4
PERPENDICULAR
AT SETTING 5
PERPENDICULAR
AT SETTING 4
CUT COAG
0
1
2
3
PEAK PlasmaBlade
Damage Score:
0 - none, 3 - severe
Polyurethane Copolymer Silicone
PARALLEL
AT 30W
PARALLEL
AT 30W
PERPENDICULAR
AT 30W
PERPENDICULAR
AT 30W
CUT COAG
0
1
2
3
Traditional ESU
Significant Reduction in Transvenous
Lead Damage When Compared to
Traditional Electrosurgical Devices
The PEAK PlasmaBlade is a surgical device that uses
very brief (40µs range), high frequency pulses of
RF energy to induce electrical plasma along the
edge of a thin (12.5µm), 99.5% insulated electrode.
Due to the low duty cycle from RF pulsing and
proprietary TPS insulating technology, the PEAK
PlasmaBlade uses less total energy and operates
at significantly lower temperatures than traditional
electrosurgical technology (40 – 170°C vs. 200 -
350°C).1,2 Comparatively, PEAK PlasmaBlade incisions
demonstrate 74% less thermal injury depth than
traditional electrosurgical devices. (p<0.05).3
Pre-clinical and clinical studies with the PEAK
PlasmaBlade have demonstrated that the
improved thermal injury profile of the device,
compared to traditional electrosurgery,
results in the following benefits:
• Improves wound strength, wound healing and the
cosmetic appearance of scars1,3,4
• Decreases inflammatory cell counts3 and serous
drainage5
•
Enables patients to return to a normal
diet earlier5
• Reduces patient intra-operative narcotic
consumption by 22% (p=0.07)5
• Reduces patient post-operative narcotic
consumption by 28% (p=0.59)5
Materials and Methods6
A series of ten polyurethane, silicone, and silicone-
urethane copolymer transvenous leads were
superficially tunneled into chicken breasts maintained
at 37°C. These leads were then subjected to simulated
surgical extraction using traditional electrosurgery
or the PEAK PlasmaBlade. Extraction was performed
with either parallel or perpendicular-to-lead technique
using purely Cut or Coag mode at 3 second power
outputs of either 20W or 30W. Lead damage was
numerically characterized (0 to 3 scale, by severity) in a
blinded fashion by visual and microscopic inspection.
Results6
Using traditional electrosurgery, significant lead
damage was noted in all polyurethane leads, with
more damage occurring with 30W vs. 20W, Cut vs.
Coag mode, and perpendicular vs. parallel orientation.
Considering alternative materials, silicone leads
demonstrated less damage than polyurethane, and
co-polymer leads demonstrated the greatest amount
of damage of all three lead types with traditional
technology. Comparatively, the PEAK PlasmaBlade
did not damage the silicone or polyurethane lead
in Coag mode with either parallel or perpendicular
technique. Using Cut mode, only minimal damage
was demonstrated with perpendicular technique
in the polyurethane and co-polymer leads. Of the
three insulation materials, silicone lead insulation
demonstrated the highest tolerance to electrosurgery,
regardless of technique or energy mode.
The PEAK PlasmaBlade: Pacemaker Generator and Battery Replacement
PEAK PlasmaBlade: 40 - 170°C1
Traditional ESU: 200 - 350°C1
Temperature Profile2
Discussion
Silicone, polyurethane, and copolymers are
widely used in transvenous pacing leads due
to their favorable flexibility, insulative, and
tunneling characteristics. While they are readily
available and cost-effective, polyurethane and
copolymers in particular are also susceptible to
damage from high-temperature electrosurgical
instruments.6,7 Surgeons are advised by lead
manufacturers to use low power settings
and maintain operative vigilance during
dissection to prevent damage. However, this
is not always possible. The consequences of
lead damage during generator or battery
replacement carry significant morbidity
and mortality risk, including increased
length of stay and death, and serious
financial implications – averaging between
$5,000 and $20,000 per incident.8 The PEAK
PlasmaBlade’s lower operating temperature
and thermal spread resulted in reduced
damage regardless of orientation or mode
when compared to traditional electrosurgery.
The PEAK PlasmaBlade: Pacemaker/ICD Implants and Revisions
The PEAK PlasmaBlade demonstrated an average 64% reduction in blade
temperature compared to traditional electrosurgery for similar Cut settings
The PEAK PlasmaBlade demonstrated an average 40% reduction in blade
temperature compared to traditional electrosurgery for similar Coag settings
PEAK PlasmaBlade Cutting Temperature
vs. Traditional ESU
PEAK PlasmaBlade Coagulation Temperature
vs. Traditional ESU
PULSAR Setting & Conventional Electrosurgery Power (W) PULSAR Setting & Conventional Electrosurgery Power (W)
Temperature (c)
Temperature (c)
PEAK PlasmaBlade Traditional Electrosurgery
PULSAR 1/2
& 10W
PULSAR 1/2
& 10W
PULSAR 3/4
& 20W
PULSAR 3/4
& 20W
PULSAR 5
& 30W
PULSAR 5
& 30W
PULSAR 6/7/8
& 40W
PULSAR 6/7/8
& 40W
PULSAR 9/10
& 50W
PULSAR 9/10
& 50W
0
350
300
250
200
150
100
50
0
300
250
200
150
100
50
PEAK PlasmaBlade Traditional Electrosurgery

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