PEAK PlasmaBlade Device
 

Clinical

The effects of thermal injury have been researched extensively. Compared to traditional electrosurgery, PEAK PlasmaBlade™ technology offers significantly improved clinical outcomes without collateral thermal damage.

Thermal Injury Matters

Less Damage Improves Healing and Clinical Outcomes

PEAK PlasmaBlade device cut vs. traditional electrosurgery cut

Detail - PEAK PlasmaBlade device cut vs. traditional electrosurgery cut

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 with superior cutting performance compared to traditional electrosurgery.1

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, additional clinical research has demonstrated significant reduction in inflammatory cell counts, improvement in healed wound strength, and equivalent cutaneous scarring to the scalpel.2

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

Detail - 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 macroscopic postoperative benefits, including:

Infrared temperatures: PEAK PlasmaBlade device vs. traditional electrosurgery

Detail - Infrared temperatures: PEAK PlasmaBlade device vs. traditional electrosurgery

  • Decreased serous drainage and seroma formation3
  • Improved VAS pain scores and narcotic consumption3
  • Increased diet volume and return to normal activity level3

Other preclinical studies have demonstrated that the PEAK PlasmaBlade surgical instrument cuts tissue at an average temperature that is half that of traditional electrosurgical devices, thus reducing the potential for injury to adjacent tissue structures during dissection.4

Based on these results, the PEAK PlasmaBlade device provides surgeons with a novel alternative to traditional technology that improves postoperative outcomes, operative efficiency, and the cost-effectiveness of healthcare.5

References/Footnotes

  1. Data on file. ETR-00127.
  2. 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.
  3. 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.
  4. Data on file. ETR-00023.
  5. Data on file. VR-0083.

PRECISE Studies for PEAK PlasmaBlade Technology

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.

The first PRECISE study was a randomized, controlled trial (RCT) of patients undergoing abdominoplasty. It demonstrated significantly improved narcotic consumption and pain scores, return to normal activity and diet volume levels, and less blood loss compared to scalpel and traditional electrosurgery.

Graph showing results of the PRECISE studies

Results of the PRECISE studies with the PEAK PlasmaBlade device

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

Thermal injury depth: PEAK PlasmaBlade device vs. Bovie

Additional studies in orthopaedic surgery1 are examining the effects of less inflammation on recovery from total joint replacement (TJR). In breast reduction2 and mastectomy,3 preliminary study results have demonstrated that the PEAK PlasmaBlade device improves cutting performance compared to traditional electrosurgery.2

Examples of reduced thermal injury with the PEAK PlasmaBlade device

Examples of reduced thermal injury with the PEAK PlasmaBlade device

References/Footnotes

  1. Data on file. VR-0083.
  2. Data on file. VR-00065.
  3. 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.

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.

PEAK PlasmaBlade Technology – GeneralPEAK PlasmaBlade Technology – General

Reconstructive and Plastic SurgeryReconstructive and Plastic Surgery

General Surgery – Surgical Oncology General Surgery – Surgical Oncology

Pacemaker/ICD Implants and Revisions

CardiothoracicCardiothoracic

Obstetrics and Gynecologic Surgery Obstetrics and Gynecologic Surgery

NeurosurgeryNeurosurgery

ENT Surgery ENT Surgery

OtherOther

Internal Testing References Internal Testing References

 

Last updated: 26 Feb 2013

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