A new device developed by Peak Surgical (Palo Alto, California) could cut into the longstanding role played by the surgical scalpel.

For years, surgeons have used scalpels to cut skin and delicate tissues and used electrosurgical devices to cut and coagulate fat and other thicker, tougher tissues. Although scalpels can precisely cut tissue, they don't control bleeding. The alternative is electrosurgical devices, which 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.

Peak released pre-clinical study results last week showing that its PlasmaBlade Needle represents the best of both worlds, combining electrosurgery and the traditional scalpel for facial surgeries.

The company received clearance to market the device nearly two months ago (Medical Device Daily, July 25, 2008).

"With the introduction of the PlasmaBlade, general surgeons now have access to a single surgical tool that cuts tissue as precisely as a scalpel and controls bleeding as effectively as traditional electrosurgery without causing extensive collateral thermal damage to tissues," John Tighe, president/CEO of Peak Surgical, told Medical Device Daily. "It allows a burst of energy and tissue to cool."

Results were presented at the American Academy of Facial Plastic and Reconstructive Surgery (Alexandria, Virginia) conference. Posters showing results displayed a series of surgical incisions that were made on freshly excised human abdominal tissue, in vivo porcine skin and ex vivo bovine cartilage using the PlasmaBlade Needle. 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% less collateral tissue damage than the traditional electrosurgery needlepoint tip.

Evaluation of the porcine skin cuts demonstrated that the amount of bleeding following incision by the PlasmaBlade Needle was significantly reduced compared with that produced by the standard scalpel and similar to that produced with the traditional electrosurgery device.

"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 Keller, co-director of the Facial Plastic Surgery Fellowship at the University of California, Los Angeles Medical School. "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."

Here's how the device works.

Unlike most radio frequency-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 radio frequency is provided in short on-and-off pulses and the blade contains highly insulated electrodes, 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 C.

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.

"Eventually we want to go into the cardiology and ob/gyn market with this device," Tighe said.

He added that the technology "may have applications in more than 2 million surgical procedures each year."

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 (Stanford, California).

To date the company has raised more than $29 million in three rounds of private financing. In February the company reported getting $21 million in Series C financing led by Signet Healthcare Partners, with Lehman Brothers and Venrock Associates also participating (Medical Device Daily, Feb. 5, 2008).

The company was founded in August 2005.

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