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PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded Indications
Date:12/17/2008

ues. We expect the results of our PRECISE Studies to further validate our preclinical results showing effective bleeding control, minimal thermal tissue injury, positive wound healing, minimal scarring and inflammation, and improved surgical incision healing and strength compared with traditional electrosurgical devices."

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 offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical device.

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 energy is provided through short on-and-off pulses via a highly insulated cutting electrode, the PlasmaBlade cuts 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 significantly less damage to surrounding tissues compared to traditional electrosurgical devices. The PlasmaBlade is also able to dissect tissue in a wet or dry surgical field.

The pulsed plasma-mediated discharges and electrode insulation techniques were originally developed at the Hansen
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SOURCE PEAK Surgical, Inc.
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