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PEAK Surgical Announces Positive Results From Preclinical Study of PEAK PlasmaBlade(TM) for Obstetric and Gynecologic Surgery
Date:5/6/2008

- Data Presented in Poster Session at American College of Obstetricians and

Gynecologists' 56th Annual Clinical Meeting -

PALO ALTO, Calif., May 6 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that is developing new tissue dissection systems based on a proprietary technology, released results from a preclinical study demonstrating that its PEAK PlasmaBlade(TM) cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery. The PEAK PlasmaBlade is a low-temperature tissue dissection tool that uses pulsed plasma energy to create surgical incisions and control bleeding.

The data also showed improved surgical incision wound healing in an in vivo porcine model compared to traditional electrosurgery. The results were presented in a poster session at the American College of Obstetricians and Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans by lead investigator Dr. Paul Blumenthal, M.P.H., professor in the Department of Obstetrics and Gynecology at Stanford University School of Medicine.

"The findings of this comparative preclinical study of tissue cutting and healing are encouraging because they demonstrated that cuts made with the PEAK PlasmaBlade produced minimal collateral damage compared with cuts made with currently available electrosurgical instruments," Dr. Blumenthal said. "This is important because collateral tissue damage may impede wound healing, obscure histological analysis, and lead to scarring and infection in surgical patients. New surgical cutting tools that use less heat but offer precise soft-tissue cutting and coagulation with minimal thermal injury could change the way we operate."

The PEAK Surgery System is not yet available in the United States. The company has filed a 510(k) pre-market notification with the U.S. Food and Drug Administration to market the system in the United States.

Study Design

In the study, freshly excised human abdominal tissue was cut using the PEAK PlasmaBlade, an uncoated traditional electrosurgery scalpel, a teflon-coated traditional electrosurgery scalpel and a fine wire and ceramic electrosurgery scalpel. Histology samples were immediately harvested to evaluate acute thermal tissue injury.

Also as part of the study, full-thickness skin incisions were made on porcine skin using a traditional electrosurgery device, the PEAK PlasmaBlade and a standard scalpel blade. Incisions were made at days 0, 21, 28, 35 and 42, and bleeding was evaluated for 60 seconds post-incision. The wounds were then sutured to allow for healing, and digital photos of the wounds were taken every seven days to evaluate scarring based on a visual analog scale. Histological examination was conducted to evaluate healing and inflammatory response.

Study Results

Histological evaluation of the ex vivo human skin showed that the PEAK PlasmaBlade cuts produced minimal collateral damage compared to cuts made with the other electrosurgery instruments.

In the porcine skin cuts, bleeding for 60 seconds following incision was reduced by 60 percent in the wounds made by the PEAK PlasmaBlade compared with those made by the standard scalpel (p=0.0001). Wound sections showed a 75 percent reduction in acute thermal damage with the PEAK PlasmaBlade compared with the traditional electrosurgery scalpel (p<0.03). After six weeks, there was no significant difference in scar formation between the PEAK PlasmaBlade and the standard scalpel; however, scarring was reduced by 66 percent with the PEAK PlasmaBlade compared with the traditional electrosurgery device (p<0.04). Staining for inflammatory cells showed significantly less infiltration in the wounds made by the standard scalpel and the PEAK PlasmaBlade, indicating less inflammation, compared with wounds made by the traditional electrosurgery device.

"Because of its ability to precisely cut tissue while controlling bleeding and minimizing thermal damage, the PEAK PlasmaBlade has the potential to be an important dissection tool for surgical procedures," said John Tighe, president and chief executive officer of PEAK Surgical. "PEAK Surgical is committed to bringing this highly precise tissue dissection technology to market as quickly as possible."

About PEAK's Technology

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 PEAK PlasmaBlade combines into a single surgical tool the precision of a scalpel and the bleeding control of a traditional electrosurgery device.

In addition, 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 PEAK PlasmaBlade. These pulsed plasma-mediated discharges and electrode insulation techniques were originally developed at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. Because the radiofrequency is provided in short on-and-off pulses and the blade is insulated, 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 half the damage to surrounding tissues compared with traditional electrosurgical devices. The PEAK PlasmaBlade also can cut through all types of soft tissue, including skin, fat and muscle, and can dissect tissue in a wet or dry surgical field.

PEAK Surgical is planning additional preclinical and clinical studies and is exploring the applicability of its technology across numerous surgical fields, including general, cardiothoracic, gynecologic, plastic and reconstructive and neurosurgery. The company believes the technology may have applications in more than 2 million surgical procedures each year.

About PEAK Surgical, Inc.

PEAK Surgical, Inc. is a medical device company that is developing new tissue dissection systems based on a proprietary technology. PEAK's flagship product in development, the PEAK(R) Surgery System, combines the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBlade(TM), a disposable cutting tool that offers the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage. The company is exploring the applicability of this technology across numerous surgical fields, including general, cardiac, gynecologic, plastic and neuro surgery. For more information, please visit http://www.peaksurgical.com.


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SOURCE PEAK Surgical, Inc.
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