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 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 financial consequences are serious and the use of additional measures to reduce potential risk, such as the PEAK PlasmaBlade, should be considered. PEAK PlasmaBlade: Setting 5 Traditional ESU: 30 Watts Copolymer lead, perpendicular device orientation, cut mode 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 file. 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. 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. For further information, please call 866-777-9400 or 603-742-1515. You may also consult our website: www.medtronicadvancedenergy.com Medtronic Advanced Energy LLC 180 International Drive Portsmouth, NH 03801 USA www.medtronicadvancedenergy.com Tel: (866) 777-9400 Fax: (866) 222-0900 International Telephone Numbers Adriatic Regional Office 385-1-488-1120 Australia 1800-668-670 Baltic Regional Office 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 © 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 Selected References* The ThePEAK PEAKPlasmaBlade: PlasmaBlade:Pacemaker/ICD Pacemaker Generator Implants andand Battery Revisions Replacement 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: Thermal Injury Profile1 Materials and Methods6 A series of ten polyurethane, silicone, and siliconeurethane 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. Scalpel Results6 • 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 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. PEAK PlasmaBlade Cut Electrosurgery Cut Device Effect on Transvenous Lead Insulation PEAK PlasmaBlade Polyurethane Copolymer Silicone 2 1 0 PARALLEL AT SETTING 5 PERPENDICULAR AT SETTING 5 CUT PARALLEL AT SETTING 4 PERPENDICULAR AT SETTING 4 COAG Polyurethane 3 Damage Score: 0 - none, 3 - severe 3 Damage Score: 0 - none, 3 - severe Traditional ESU Copolymer Silicone 2 1 0 PARALLEL AT 30W PERPENDICULAR AT 30W CUT PARALLEL AT 30W PERPENDICULAR AT 30W COAG The ThePEAK PEAKPlasmaBlade: PlasmaBlade:Pacemaker/ICD Pacemaker Generator Implants andand Battery Revisions Replacement 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 PEAK PlasmaBlade: 40 - 170°C1 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. Traditional ESU: 200 - 350°C1 Temperature Profile2 PEAK PlasmaBlade Cutting Temperature vs. Traditional ESU PEAK PlasmaBlade 350 PEAK PlasmaBlade Coagulation Temperature vs. Traditional ESU Traditional Electrosurgery 300 200 200 Temperature (c) Temperature (c) Traditional Electrosurgery 250 250 150 100 150 100 50 50 0 PEAK PlasmaBlade 300 PULSAR 1/2 & 10W PULSAR 3/4 & 20W PULSAR 5 & 30W PULSAR 6/7/8 & 40W PULSAR 9/10 & 50W PULSAR Setting & Conventional Electrosurgery Power (W) The PEAK PlasmaBlade demonstrated an average 64% reduction in blade temperature compared to traditional electrosurgery for similar Cut settings 0 PULSAR 1/2 & 10W PULSAR 3/4 & 20W PULSAR 5 & 30W PULSAR 6/7/8 & 40W PULSAR 9/10 & 50W PULSAR Setting & Conventional Electrosurgery Power (W) The PEAK PlasmaBlade demonstrated an average 40% reduction in blade temperature compared to traditional electrosurgery for similar Coag settings
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