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PEAK Surgical Introduces PlasmaBlade(TM) Product Line Extensions for Use in General Surgery
Date:10/28/2008

- PlasmaBlade Needle and PlasmaBlade EXT Extend PlasmaBlade Family of Tissue Dissection Tools, Which Have Been Used in More Than 150 Surgical

Procedures Since FDA Clearance in July -

PALO ALTO, Calif., Oct. 28 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, has introduced two extensions to its PEAK PlasmaBlade(TM) family of disposable surgical cutting and coagulation tools. The PlasmaBlade Needle, which has a fine needlepoint tip, is specifically designed for ultra-precise surgical procedures. The PlasmaBlade EXT is designed for use in surgical procedures requiring an extended-reach tip.

In July, the U.S. Food and Drug Administration granted PEAK Surgical 510(k) clearance to market the PEAK(R) Surgery System, including the PlasmaBlade 4.0, for use in general surgery. The PlasmaBlade 4.0 is designed to be used to cut through all types of soft tissue, including skin, fat and muscle. All of the PlasmaBlade tissue dissection tools are used in conjunction with PEAK's PULSAR(TM) Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to create surgical incisions and control bleeding. They offer the exacting control of a scalpel and the coagulation of traditional electrosurgery without extensive collateral damage.

Since FDA clearance, surgeons have used the PlasmaBlade 4.0 in more than 150 surgical procedures, including in general, gynecologic, orthopedic, cardiothoracic, plastic and reconstructive surgeries.

"The PlasmaBlade will change the way our practice performs surgery because we will no longer need to switch between a scalpel and a traditional electrosurgery device depending on the surgical field and type of tissue we are cutting," said Dr. Jonathan S. Berek, professor and chair of the Department of Obstetrics and Gynecology at Stanford University School of Medicine and co-director of the Women's Cancer Program at the Stanford Cancer Center. "Since our practice has adopted the PlasmaBlade, we have found that we can cut through all types of tissue quickly and precisely with minimal bleeding and improved surgical incision healing for the patient. With the extended shaft on the PlasmaBlade EXT, we will be able to reach tissues and structures that reside deeper in the abdomen."

"The PlasmaBlade cuts more precisely than a traditional scalpel and causes less thermal tissue damage than traditional electrosurgery. Also, because it cuts at a much lower temperature and delivers less heat, we have seen minimal tissue charring and reduced surgical smoke, which is a concern given the potential health risks," said Dr. Bryant A. Toth, plastic and reconstructive surgeon at California Pacific Medical Center. "We expect the PlasmaBlade Needle to allow us to provide even more focused precision, such as for surgical procedures involving very delicate face and eyelid skin."

Benefits of the PlasmaBlade and PULSAR Generator

For decades, surgeons have relied on scalpels to cut skin and delicate tissues and used electrosurgical devices to cut and coagulate fat and other thicker, tougher tissues. Although scalpels precisely cut tissue, they do not control bleeding. Electrosurgical devices, on the other hand, cut efficiently and control bleeding but can cause extensive thermal damage to surrounding tissue. In cases where the risk of collateral damage or scarring from electrosurgery is considered to be unacceptable, surgeons must use both a traditional scalpel for cutting and an electrosurgery device for coagulation. The PlasmaBlade offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical tool.

Unlike most radiofrequency-based surgical products that use continuous voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed plasma-mediated electrical discharges through the PlasmaBlade. Because the radiofrequency is provided in short on-and-off pulses and the blade contains a highly insulated cutting electrode, the PlasmaBlade cuts tissue at an average temperature that is half that of a conventional electrosurgery device and can be as low as 50 degrees Centigrade. This temperature reduction results in reduced heat transfer and significantly less damage to surrounding tissues compared with traditional electrosurgical devices. The PlasmaBlade also can dissect tissue in a wet or dry surgical field.

The pulsed plasma-mediated discharges and electrode insulation techniques were originally developed at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University.

About PEAK Surgical, Inc.

PEAK Surgical, Inc. is a medical device company that has developed the PEAK(R) Surgery System, a new tissue dissection system based on a proprietary technology that represents an important advance in radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBlade(TM), a family of disposable cutting tools that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage, and the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is cleared for use in general surgery in the United States. For more information, please visit http://www.peaksurgical.com.


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SOURCE PEAK Surgical, Inc.
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