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PEAK Surgical Announces Positive Fascia Incision Healing Results From Preclinical Study of PEAK PlasmaBlade(TM) for Gynecologic Surgery
Date:5/7/2009

- Data Presented in Poster Session at American College of Obstetricians and Gynecologists' 57th Annual Clinical Meeting -

PALO ALTO, Calif., May 7 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, released results from a preclinical study demonstrating that the use of its PEAK PlasmaBlade(TM) is associated with improved fascia incision healing in an in vivo model compared to the use of traditional electrosurgery. Overall, the PlasmaBlade demonstrated reductions in acute thermal injury depth, healed fascial scar width and inflammatory response with greater healed wound strength.

The study results were presented in a poster session at the American College of Obstetricians and Gynecologists' (ACOG) 57th Annual Clinical Meeting in Chicago by lead investigator Dr. Mary T. Jacobson, clinical assistant professor in the Department of Obstetrics and Gynecology at Stanford University School of Medicine.

"The findings of this comparative preclinical study are encouraging because they demonstrated that fascial incisions made with the PlasmaBlade were stronger than the standard of care at one week following surgery - a critical point when abdominal surgery patients are becoming more mobile. We believe this result is the product of the PlasmaBlade being able to cut and coagulate at a much lower temperatures, thus producing significantly less collateral tissue damage than incisions made with traditional electrosurgery. Because collateral tissue damage impedes wound healing, reducing this is important for patients undergoing gynecologic procedures where a faster recovery is desired," said Dr. Jacobson. "The PlasmaBlade is an important new device for surgery because it delivers scalpel-like cutting precision with improved healing characteristics compared to traditional electrosurgery."

The PEAK PlasmaBlade(TM) is a family of disposable, low-temperature surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage. The PlasmaBlade is part of the PEAK(R) Surgery System, which also includes the PULSAR(R) Generator. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. The PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the United States, and for use in general surgery in the European Union. It was launched in July 2008 in the United States and has been used by U.S. surgeons on more than 1,000 patients, including general, gynecologic, and plastic and reconstructive surgeries.

Study Design and Results

In the study presented at the ACOG Annual Meeting, midline abdominal fascia incisions were made in a rat model using the PlasmaBlade, a standard scalpel blade and a traditional electrosurgery tip on the Cut and Coagulation settings. Incisions were closed with a nylon suture and monitored for healing. Wound tissue samples were harvested immediately after incision and at weeks 1, 2, 3 and 6, and compared with a skin-only incision control to evaluate for thermal injury depth, inflammatory response, collagen deposition and stage of healing. Results showed:

  • Histological evaluation of the rat fascia incisions demonstrated that the PlasmaBlade produced a 75 percent reduction in acute thermal injury depth with significant reductions in healed fascial scar width at 1, 2 and 6 weeks compared to the traditional electrosurgery tip.
  • The PlasmaBlade incisions demonstrated reduced inflammatory response at Week 1 compared with the scalpel incisions (p=0.0001), and at Weeks 1 and 2 compared with the traditional electrosurgery tip on the Cut setting (p=0.02) and Coagulation setting (p=0.006).
  • The PlasmaBlade and scalpel were associated with greater wound strength than traditional electrosurgery on the Cut setting at Week 1 (p=0.004), with a continued trend of greater wound strength compared with the traditional electrosurgery tip on the Cut setting (p=0.22) at Week 2.

Benefits of the PlasmaBlade and PULSAR Generator

For decades, surgeons have relied on scalpels to cut skin and delicate tissues and have 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 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 electrosurgical device for coagulation.

The PlasmaBlade family of devices offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical instrument. The PlasmaBlade family includes the PlasmaBlade 4.0, which is designed to be used to cut through all types of soft tissue, including skin, fat and muscle; the PlasmaBlade Needle, which has a fine needlepoint tip and is specifically designed for ultra-precise surgical procedures; and the PlasmaBlade EXT, which is designed for use in surgical procedures requiring an extended-reach tip.

Unlike most radiofrequency-based surgical products that use continuous voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. Because the radiofrequency energy is provided through short on-and-off pulses via a highly insulated cutting electrode, the PlasmaBlade cuts at half the average temperature of a conventional electrosurgery device and can be as low as 50 degrees Centigrade. This temperature reduction results in significantly less damage to surrounding tissues compared to traditional electrosurgery. The PlasmaBlade is also able to dissect tissue in a completely submerged surgical field, another shortcoming of traditional electrosurgical devices.

Preclinical results have demonstrated that the PlasmaBlade is associated with effective bleeding control, minimal thermal tissue injury, reduced scarring and inflammation, and improved surgical incision healing and strength compared with traditional electrosurgical or electrocautery devices.

PEAK Surgical's pulsed plasma-mediated discharges and electrode insulation techniques were originally invented at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University and developed by PEAK Surgical.

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 devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage, and the PULSAR(R) Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the United States, and for use in general surgery in the EU. For more information, please visit www.peaksurgical.com.


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SOURCE PEAK Surgical, Inc.
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