Peak Surgical Preclinical Study of PEAK PlasmaBlade Needle showing positive results





PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced preclinical study results showing that its PEAK PlasmaBladeTM Needle cuts tissue with significantly reduced thermal tissue injury compared to traditional electrosurgery and significantly less bleeding than that produced by a standard scalpel.

Traditional electrosurgical instruments produce a zone of thermal injury to surrounding tissue, which can limit their use in facial surgery, said lead study investigator Dr. Gregory S. Keller, co-director of the Facial Plastic Surgery Fellowship at the University of California, Los Angeles Medical School and clinical associate professor of surgery at UCLA. "The findings of this comparative preclinical study demonstrate that the PlasmaBlade Needle causes less thermal tissue damage than traditional electrosurgery because it cuts and coagulates at a much lower temperature and delivers less heat. Reducing collateral tissue damage is important for improved surgical incision wound healing. The PlasmaBlade Needle may be an important surgical tool for facial tissue dissection in plastic and reconstructive surgery."

Dr. Keller presented the study results today in a poster session at the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) Annual Fall Meeting in Chicago. The data also will be featured in a panel discussion, titled "Minimally Invasive vs Maximally Effective Treatments: The Role of Office-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. Food and Drug Administration, is a disposable surgical cutting and coagulation tool designed for use by surgeons doing ultra-precise surgical procedures. It is a component of the PEAK® Surgery System together with the PULSARTM Generator, which supplies the PlasmaBlade Needle with pulsed plasma radiofrequency energy. The PlasmaBlade Needle is one of a family of disposable cutting tools that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage. The PlasmaBladeTM 4.0, which was the first PEAK Surgical device to be FDA cleared, is designed to cut through all types of soft tissue, including skin, fat and muscle. The PlasmaBlade Needle is designed for use when a fine needlepoint tip is desired.

Study Design and Results

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

Histological evaluation of the human skin, porcine skin and cartilage samples showed that incisions made with the PlasmaBlade Needle produced nearly 50 percent less collateral tissue damage than the traditional electrosurgery needlepoint tip. Evaluation of the porcine skin cuts showed that the amount of bleeding following incision by the PlasmaBlade Needle was significantly reduced compared with that produced by the standard scalpel (p=0.001) and similar 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 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 half the 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.

PEAK Surgical is exploring the applicability of its technology across numerous surgical fields beyond general surgery, including 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 has developed the PEAK® Surgery System, a new tissue dissection system based on a proprietary technology that represents an evolutionary leap in the advancement of radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBladeTM, a family of disposable cutting tools that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage, and the PULSARTM 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. The company is exploring the applicability of this technology across additional surgical fields, including cardiothoracic, gynecologic, plastic and reconstructive, and neurosurgery. For more information, please visit www.peaksurgical.com.