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Healthcare Professionals
The effects of thermal injury have been researched extensively. Some of these clinical outcomes are outlined below.
Less Damage Improves Healing and Clinical Outcomes
Since Bovie and Cushing used the first electrosurgical instruments in 1928, little has been done to reduce the collateral thermal damage inherent to this technology. Although thermal injury depth may vary with power setting, pass rate, electrode design, and tissue type, traditional electrosurgical instruments demonstrate average injury values of 500μm to 1.5mm deep to incised tissue. Comparatively, the PEAK PlasmaBlade™ surgical device demonstrates thermal injury values on
the order of 50μm to 250μm.
The postoperative benefits of low thermal technology are well known. Multiple human and animal clinical studies have demonstrated that a reduced thermal injury profile results in improved healing characteristics. Specific to the PEAK PlasmaBlade device, clinical research has demonstrated significant reduction in thermal injury depth, inflammatory response and healed scar width compared to traditional electrosurgery; and equivalence in healed incision strength, inflammatory cell counts and healed scar width compared to scalpel.1-3,*
When this reduction in thermal injury compared to traditional electrosurgery is applied over a large area – as with surgeries requiring extensive electrosurgical tissue dissection – use of the PEAK PlasmaBlade device has resulted in macroscopic postoperative benefits, such as patients reached 50% of normal diet by day 2 (median) vs. day 6.5 (median) for SOC (p = 0.0047).4,*
The PEAK PlasmaBlade uses less total energy and operates at significantly lower temperatures than traditional electrosurgical technology (40 – 170°C vs. 200 – 350°C).5,** The PEAK PlasmaBlade device provides surgeons with a novel alternative to traditional technology that eliminates the risk of scalpel injuries6 and has been shown to dissect 24% (p = 0.0002) more grams of tissue per minute than traditional electrosurgery, increasing surgical efficiency.7,*
Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009;124(6):1849-1859.
Ruidiaz ME, Messmer D, Atmodjo DY, et al. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111.
Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative healing of rat fascia following incision with three surgical instruments. J Surg Res. 2011;167(1):47-54.
Data on file. VR-00055 study summary. 71-10-2456.
Data on file. PEAK PlasmaBlade operating temperature study summary. 71-10-2475.
Vose JG, McAdara-Berkowitz J. Reducing scalpel injuries in the operating room. AORN J. 2009;90(6):867-872.
Data on file. VR-00065 study summary. 71-10-2453.
* Performance has not been specific established in all procedures.
** Operating temperature is a function of device settings, electrode configuration and treatment time. Operating temperatures outside this range may be observed.
Lowering Thermal Damage Improves Outcomes
The PRECISE family of clinical studies encompasses PEAK PlasmaBlade research in plastic, breast, orthopaedic, and oncologic surgery. This work has demonstrated that the PEAK PlasmaBlade System produces significantly improved postoperative outcomes in humans compared to the standard of care technology. Additional pre-clinical research in animal models has supported these results.
A prospective, randomized, controlled study to evaluate patients undergoing abdominoplasty demonstrated that PEAK PlasmaBlade patients reached 50% of normal diet by day 2 (median) vs. day 6.5 (median) for SOC (p = 0.0047), compared to scalpel and traditional electrosurgery1,* as well as a 59% reduction in blood loss during skin incisions, compared to scalpel.2,*
The results of the abdominoplasty this study were presented at the 2009 annual meetings of the American College of Surgeons and European Society of Plastic, Reconstructive, and Aesthetic Surgery.
Thermal injury depth: PEAK PlasmaBlade device vs. Bovie
The PEAK PlasmaBlade’s novel pulsed RF energy and highly-insulated electrode design allows for significantly improved dissection performance, compared to traditional electrosurgery. Unlike traditional electrosurgical tools, the PEAK PlasmaBlade maintains its cutting effectiveness and hemostatic ability even when submerged in liquified tissue or blood, unlike traditional electrosurgical tools.2,* This unimpeded performance in wet and dry surgical fields simplifies surgical procedures, eliminating the need for instrument exchanges.3,* This increase in surgical efficiency may reduce time spent in the operating room.
Additional studies have demonstrated significantly reduced thermal injury depth, inflammatory response and healed scar width compared to traditional electrosurgery,4,* and equivalence in healed incision strength, inflammatory cell counts and healed scar width compared to scalpel.1,4,5,*
Examples of Reduced Thermal Injury with the PEAK PlasmaBlade Device
Data on file. VR-00055 study summary. 71-10-2456.
Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009;124(6):1849-1859.
Palanker DV, Vankov A, Huie P. Electrosurgery with cellular precision. IEEE Trans Biomed Eng. 2008;55(2 Pt 2):838-841.
Ruidiaz ME, Messmer D, Atmodjo DY, et al. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111.
Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative healing of rat fascia following incision with three surgical instruments. J Surg Res. 2011;167(1):47-54.
* Performance has not been specifically established in all procedures.
Research documenting the preclinical and clinical performance of the PEAK® System has been published in major peer-reviewed journals and awarded podium presentations at international surgical conferences including the annual meetings of the American College of Surgeons, Plastic Surgery Research Council, American Society of Breast Surgeons, American College of Obstetrics and Gynecology, and the European Plastic Surgery Research Council.
Peer-Reviewed Publications
Chang EI, Carlson GA, Vose JG, Huang EJ, Yang GP. Comparative Healing of Rat Fascia Following Incision with Three Surgical Instruments. E-Published, January 2011. J Surg Res. 2011; 167(1): e47-54. Chronic wound healing study conducted in living rat model.
Vose JG, Berkowitz JM. Reducing Scalpel Injuries in the Operating Room. Journal of the AORN. 2009; 90(6):867-872.
Palanker DV, Vankov A, Jayaraman P. On Mechanisms of Interaction in Electrosurgery. New Journal of Physics. 2008 Dec;10: 123022.
Palanker DV, Vankov A, Huie P. Electrosurgery with Cellular Precision. IEEE Transactions on Biomedical Engineering. 2007 Feb;55(2 pt 2): 838-841.
Vankov A, Palanker DV. Nanosecond plasma-mediated electrosurgery with elongated electrodes. Journal of Applied Physics. 2007;101: 124701.
Stoker R, Vose JG. Advances in Electrosurgery: Safety and Economic Benefits for Patients, Surgeons, and Hospitals. Managing Infection Control Magazine. 2009; 9(8): 42-47.
Peer-Reviewed Publications
Ruidiaz ME, Messmer D, Huang EJ, Atmodjo DY, Vose JG, Rosenberg HL, Kummel AC, Gurtner GC. Comparative Healing of Human Cutaneous Surgical Incisions Created by the PEAK PlasmaBlade, Conventional Electrosurgery, and a Standard Scalpel. Journal of Plastic and Reconstructive Surgery. 2011; 128(1): 104-111. Chronic wound healing study conducted in subjects undergoing abdominoplasty.
Punthakee X, Keller GS, Vose JG, Stout W. New Technologies in Aesthetic Blepharoplasty and Brow-Lift Surgery. Facial Plastic Surgery. 2010;26:260-265.
Loh S, Carlson GA, Chang EI, Huang EJ, Palanker D, Gurtner GC. 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.
Invited Podium Presentations
Chang EI, et al. Comparative Healing of Surgical Incisions in Rat Fascia Created by the PEAK PlasmaBlade®, Conventional Electrosurgery, and a Standard Scalpel. Plastic Surgery Research Council Annual Meeting, San Francisco, CA, May 24, 2010.
Gurtner GC, et al. Results of the PRECISE Abdominoplasty Study: Improved Outcomes with the PEAK PlasmaBlade Compared to Scalpel and Traditional Electrosurgery. American College of Surgeons Annual Meeting, Chicago, IL, October 20, 2009.
Vose JG, et al. A Randomized Controlled Trial of the PEAK PlasmaBlade vs. Scalpel and Traditional Electrosurgery in Abdominoplasty. European Plastic Surgery Research Council Annual Meeting, Hamburg, Germany, August 22, 2009.
Keller G, et al. Evaluation of the PEAK PlasmaBlade® for Facial Plastic Surgery. American Academy of Facial Plastic Surgery Annual Meeting, Chicago, IL, October 21, 2008.
Loh SA, et al. Comparative Healing of Surgical Incisions Created by Conventional Electrosurgery, a Standard Scalpel Blade, and the PEAK PlasmaBlade®. Plastic Surgery Research Council Annual Meeting, Springfield, IL, May 28-31, 2008.
Loh SA, et al. Comparative Healing of Surgical Incisions Created by Conventional Electrosurgery, a Standard Scalpel Blade, and the PEAK PlasmaBlade®. American College of Surgeons Annual Meeting, New Orleans, LA, October 9, 2007.
Peer-Reviewed Posters and Abstracts
Evaluation of the PEAK PlasmaBlade for Facial Plastic Surgery. Keller GS, Huang EJ, Carlson GA, Vose JG. American Academy of Facial Plastic Surgery Annual Meeting, Chicago, IL, September 18-21, 2008.
Peer-Reviewed Publications
Fine RE, Vose JG. Traditional electrosurgery and a low-thermal-injury dissection device yield different outcomes following bilateral skin-sparing mastectomy: a case report. Journal of Medical Case Reports. 2011, 5:212.
Peer-Reviewed Posters and Abstracts
Naruns P, Vose JG, Atmodjo DY, Sangoi A. A Randomized Controlled Trial of the PEAK PlasmaBlade® in Open Breast Biopsy Compared to Scalpel and Traditional Electrosurgery. American Society of Breast Surgeons Annual Meeting, Las Vegas, NV. April 28 – May 1, 2010.
Ruidiaz ME, Martin DT, Ta CN, Cortes-Mateos MJ, Vose JG, Wang-Rodriguez J, Kummel AC, Blair SL. A Prospective Controlled Trial of the PEAK PlasmaBlade® in the Evaluation of Breast Cancer Surgical Specimens with Touch Prep. Presented at the American Society of Breast Surgeons Annual Meeting, Las Vegas, NV. April 28 – May 1, 2010.
Post-Surgical Incision Healing of Fascia and Skin: A Comparative Evaluation of the PEAK PlasmaBlade, Scalpel, and Traditional Electrosurgery. Loh SA, Chang EI, Jacobson MT, Huang EJ, Vose JG, Carlson GA, Gurtner GC, Yang GP, Berek JS. Society of Gynecologic Oncology Annual Meeting, San Antonio, TX, February 5 – 8, 2009.
Peer-Reviewed Publications
Vose JG, Marieb M. Reducing the Risk of Transvenous Lead Damage During Pacemaker and ICD Generator Replacement. EP Lab Digest. 2010;1(10):28-31
Invited Podium Presentations
Weisberg IL, Desai S, Davison P, Shah D, Baez-Escudero J, Beshai J, Burke MC, Knight BP. Effects of Pulsed RF Energy Compared to Standard Electrocautery on Transvenous Lead Insulation Materials. Cardiostim Annual Meeting, Nice, France, June 18, 2010.
Peer-Reviewed Posters and Abstracts
Weisberg IL, Desai S, Davison P, Shah D, Baez-Escudero J, Beshai J, Burke MC, Knight BP. Effects of Pulsed RF Energy Compared to Standard Electrosurgery on Transvenous Lead Insulation Materials. Heart Rhythm Society Annual Meeting, Denver, CO, May 12 – 15, 2010.
Peer-Reviewed Publications
Vose JG, Ihnken K, et al. Comparison of Porcine Internal Thoracic Artery Harvest with the PEAK PlasmaBlade ® vs. Harmonic Scalpel and Traditional Electrosurgery. Cardiothoracic Surgery Symposium, San Diego, CA, February 22, 2009.
Peer-Reviewed Posters and Abstracts
Comparison of Porcine Internal Thoracic Artery Harvest with the PEAK PlasmaBlade vs. Harmonic Scalpel and Traditional Electrosurgery. Vose JG, Atmodjo DY, Schwartz SP, Ihnken K. Cardiothoracic Surgery Symposium, San Diego, CA, February 22, 2009.
Peer-Reviewed Publications
Jacobson MT. Pulsed Electron Avalanche Knife PlasmaBlade. Expert Reviews in Obstetrics and Gynecology. 2010; 5(1):19-22.
Peer-Reviewed Posters and Abstracts
Jacobson MT, Chang EI, Huang EJ, Carlson GA, Vose JG, Yang GP, Berek JS. Evaluation of Midline Fascia Healing with the PEAK PlasmaBlade ® vs. Traditional Electrosurgery and Scalpel. Presented at the American College of Obstetrics and Gynecology Annual Meeting, Chicago, IL. May 2 – 6, 2009
Post-Surgical Incision Healing of Fascia and Skin: A Comparative Evaluation of the PEAK PlasmaBlade, Scalpel, and Traditional Electrosurgery. Loh SA, Chang EI, Jacobson MT, Huang EJ, Vose JG, Carlson GA, Gurtner GC, Yang GP, Berek JS. Society of Gynecologic Oncology Annual Meeting, San Antonio, TX, February 5 – 8, 2009.
Evaluation of PEAK PlasmaBlade for Obstetric and Gynecologic Surgery vs. Traditional Electrosurgery. P Blumenthal, MT Jacobson, E Huang, GA Carlson, and JS Berek. American College of Obstetrics and Gynecology 2008 Annual Meeting, New Orleans, LA, May 3-7, 2008.
Peer-Reviewed Posters and Abstracts
Evaluation of the PEAK Electrosurgical Tool in Neurosurgery Applications Compared to Standard Electrosurgical Tools and Standard Scalpel Blade. Carlson GA, Taylor S, Shuer LM. Congress of Neurological Surgeons Annual Meeting, San Diego, CA, September 15-20, 2007.
Invited Podium Presentations
Vose JG, Atmodjo DY, Weeks W. A Randomized, Controlled Study of the PEAK PlasmaBlade TnA in Adult Tonsillectomy Compared to Traditional Electrosurgery. American Academy of Otolaryngology Annual Meeting, San Francisco, CA, September 11 - 14, 2011.
Chang KW, et al. Evaluation of the PEAK PlasmaBlade™ for ENT Surgery. American Academy of Otolaryngology – Head and Neck Surgery Annual Meeting, Chicago, IL, October 23, 2008.
Peer-Reviewed Publications
Palanker DV, Vankov A, Huie P. Anterior Capsulotomy with a Pulsed Electron Avalanche Knife. Journal of Cataract Refractive Surgery. 2010 Jan; 36(1):127-32.
Priglinger SG, Palanker DV, Alge CS, Kreutzer TC, Haritoglou C, Grueterich M, Kampik A. Pulsed electron avalanche knife: new technology for cataract surgery. British Journal of Ophthalmology. 2007 Jul;91(7):949-54.
Priglinger SG, Haritoglou C, Palanker DV, Kook D, Grueterich M, Mueller A, Alge CS, Kampik A. Pulsed electron avalanche knife for capsulotomy in congenital and mature cataract. Journal of Cataract and Refractive Surgery. 2006 Jul;32(7):1085-1088.
Priglinger SG, Haritoglou C, Mueller A, Grueterich M, Strauss RW, Alge CS, Gandorfer A, Palanker DV, Kampik A. Pulsed electron avalanche knife in vitreoretinal surgery. Retina. 2005 Oct-Nov;25(7):889-896.
Priglinger SG, Haritoglou C, Palanker DV, Alge CS, Gandorfer A, Kampik A. Pulsed electron avalanche knife (PEAK-fc) for dissection of retinal tissue. Archives of Ophthalmology. 2005 Oct;123(10):1412-18.
Miller JM, Palanker DV, Vankov A, Marmor MF, Blumenkranz MS. Precision and safety of the pulsed electron avalanche knife in vitreoretinal surgery. Archives of Ophthalmology. 2003 Jun;121(6):871-877.
Palanker DV, Marmor MF, Branco A, Huie P, Miller JM, Sanislo SR, Vankov A, Blumenkranz MS. Effects of the pulsed electron avalanche knife on retinal tissue. Archives of Ophthalmology. 2002 May;120(5):636-640.
Palanker DV, Miller JM, Marmor MF, Sanislo SR, Huie P, Blumenkranz MS. Pulsed electron avalanche knife (PEAK) for intraocular surgery. Invest Ophthalmol Vis Sci. 2001 Oct;42(11):2673-78.