Healthcare Professionals
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Healthcare Professionals
The effects of thermal injury have been researched extensively. Some of these clinical outcomes are outlined below.
Since Bovie and Cushing used the first electrosurgical instruments in 1928, little had been done to reduce the collateral thermal damage inherent to this technology. The PEAK PlasmaBlade is a unique soft tissue dissection instrument. Energy output from an electrosurgical generator, utilizing varying pulsed waveforms and duty cycles for both the cut and coagulation modes, induces electrical plasma along the cutting edges of a thin (nominally 12.5μm), 99.5% insulated electrode.
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,*
Wound strength comparison: PEAK PlasmaBlade device, scalpel, and traditional electrosurgery
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 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°C – 170°C vs. 200°C – 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 operative efficiency.7,*
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,**
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;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 specifically 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.
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 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;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® Surgery 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.
PEAK PlasmaBlade Technology – General |
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Peer-Reviewed Publications
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Reconstructive and Plastic Surgery |
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Peer-Reviewed Publications
Invited Podium Presentations
Peer-Reviewed Posters and Abstracts
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General Surgery -- Surgical Oncology |
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Peer-Reviewed Publications
Invited Podium Presentations
Peer-Reviewed Posters and Abstracts
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Cardiothoracic |
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Peer-Reviewed Publications
Peer-Reviewed Posters and Abstracts
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Obstetrics and Gynecologic Surgery |
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Peer-Reviewed Publications
Peer-Reviewed Posters and Abstracts
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Neurosurgery |
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Peer-Reviewed Posters and Abstracts
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ENT Surgery |
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Invited Podium Presentations
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Other |
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Peer-Reviewed Publications
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Internal Testing References |
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