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PEAK Surgical Announces Positive Results From Preclinical Study of PEAK PlasmaBlade(TM) Needle

Thursday, September 18, 2008 General News J E 4
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PALO ALTO, Calif. and CHICAGO, Sept. 18 PEAK Surgical,Inc., a medical device company that has developed a new tissue dissectionsystem based on a proprietary technology, announced preclinical study resultsshowing that its PEAK PlasmaBlade(TM) Needle cuts tissue with significantlyreduced thermal tissue injury compared to traditional electrosurgery andsignificantly less bleeding than that produced by a standard scalpel.

"Traditional electrosurgical instruments produce a zone of thermal injuryto surrounding tissue, which can limit their use in facial surgery," said leadstudy investigator Dr. Gregory S. Keller, co-director of the Facial PlasticSurgery Fellowship at the University of California, Los Angeles Medical Schooland clinical associate professor of surgery at UCLA. "The findings of thiscomparative preclinical study demonstrate that the PlasmaBlade Needle causesless thermal tissue damage than traditional electrosurgery because it cuts andcoagulates at a much lower temperature and delivers less heat. Reducingcollateral tissue damage is important for improved surgical incision woundhealing. The PlasmaBlade Needle may be an important surgical tool for facialtissue dissection in plastic and reconstructive surgery."

Dr. Keller presented the study results today in a poster session at theAmerican Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) AnnualFall Meeting in Chicago. The data also will be featured in a panel discussion,titled "Minimally Invasive vs Maximally Effective Treatments: The Role ofOffice-Based Procedures in Facial Plastic Surgery," on Saturday, September 20,in which Dr. Keller will participate.

The PlasmaBlade Needle, which has been cleared for use by the U.S. Foodand Drug Administration, is a disposable surgical cutting and coagulation tooldesigned for use by surgeons doing ultra-precise surgical procedures. It is acomponent of the PEAK(R) Surgery System together with the PULSAR(TM)Generator, which supplies the PlasmaBlade Needle with pulsed plasmaradiofrequency energy. The PlasmaBlade Needle is one of a family of disposablecutting tools that offer the exacting control of a scalpel and the bleedingcontrol of traditional electrosurgery without the extensive collateral damage.The PlasmaBlade(TM) 4.0, which was the first PEAK Surgical device to be FDAcleared, is designed to cut through all types of soft tissue, including skin,fat and muscle. The PlasmaBlade Needle is designed for use when a fineneedlepoint tip is desired.

Study Design and Results

In the study presented at the AAFPRS conference, a series of surgicalincisions were made on freshly excised human abdominal tissue, in vivo porcineskin and ex vivo bovine cartilage using the PlasmaBlade Needle, a standardscalpel blade and a traditional electrosurgery needlepoint tip. Blood lossfollowing the incisions in porcine skin was collected, and histology sampleswere immediately harvested to evaluate acute thermal tissue injury.

Histological evaluation of the human skin, porcine skin and cartilagesamples showed that incisions made with the PlasmaBlade Needle produced nearly50 percent less collateral tissue damage than the traditional electrosurgeryneedlepoint tip. Evaluation of the porcine skin cuts showed that the amount ofbleeding following incision by the PlasmaBlade Needle was significantlyreduced compared with that produced by the standard scalpel (p=0.001) andsimilar to that produced with the traditional electrosurgery device.

Benefits of the PlasmaBlade and PULSAR Generator

For decades, surgeons have relied on scalpels to cut skin and delicatetissues and used electrosurgical devices to cut and coagulate fat and otherthicker, tougher tissues. Although scalpels precisely cut tissue, they do notcontrol bleeding. Electrosurgical devices, on the other hand, cut efficientlyand control bleeding but can cause extensive thermal damag
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