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FDA OKs clearance for Peak surgery system

Article-FDA OKs clearance for Peak surgery system

Peak Surgical, Inc. has received FDA clearance to market its Peak surgery system for general surgery use. According to its manufacturer, the system combines the Pulsar Generator, which supplies pulsed plasma radiofrequency energy, with the Peak PlasmaBlade 4.0, a low-temperature surgical cutting and coagulation tool.

The Peak Surgery System includes a cart and wireless foot switch, as well as video, a brochure, fact sheets, product images, scientific literature and surgeon testimonials.

The company states that the PlasmaBlade combines into a single surgical tool the precision of a scalpel and the bleeding control of a traditional electrosurgery device. The Pulsar Generator supplies pulsed plasma-mediated electrical discharges through the PlasmaBlade. The radiofrequency is provided in short on-and-off pulses and the blade contains highly insulated electrodes enabling the PlasmaBlade to cut tissue at an average temperature half that of a conventional electrosurgery device. The PlasmaBlade also can dissect tissue in a wet or dry surgical field.

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