PEAK Surgical Announces Positive Results From Preclinical Study

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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.