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PEAK PlasmaBlade Device

Clinical

The effects of thermal injury have been researched extensively. Some of these clinical outcomes are outlined below.

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Thermal Injury Matters

Thermal Injury Matters

Histology Image

PEAK PlasmaBlade device cut vs. traditional electrosurgery cut

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.

Wound strength comparison: PEAK PlasmaBlade device, scalpel, and traditional electrosurgery

Wound strength comparison: PEAK PlasmaBlade device, scalpel, and traditional electrosurgery

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,*

Infrared temperatures: PEAK PlasmaBlade device v. traditional electrosurgery

Infrared temperatures: PEAK PlasmaBlade device vs. traditional electrosurgery

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,*


References/Footnotes

1

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.

2

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.

3

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.

4

Data on file. VR-00055 study summary. 71-10-2456.

5

Data on file. PEAK PlasmaBlade operating temperature study summary. 71-10-2475.

6

Vose JG, McAdara-Berkowitz J. Reducing scalpel injuries in the operating room. AORN J. 2009;90(6):867-872.

7

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.

Precise Studies

Scientific Literature about PEAK PlasmaBlade® Technology

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.

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PEAK PlasmaBlade Technology – General

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.

Reconstructive and Plastic Surgery

General Surgery – Surgical Oncology

Pacemaker/ICD Implants and Revisions

Cardiothoracic

Obstetrics and Gynecologic Surgery

Neurosurgery

ENT Surgery

Other

Internal Testing References