Two-in-one surgical tool meets FDA approval
The American Food and Drug Administration has granted Peak Surgical, approval to market its PEAK Surgery System for use in general surgery.
The PEAK Surgery System combines the PULSAR Generator, which supplies pulsed plasma radio frequency energy, with the PEAK PlasmaBlade 4.0, a low-temperature surgical cutting and coagulational tool.
Traditionally surgeons use scalpels to cut skin and delicate tissue, and electrosurgical devices for cutting and coagulating fat and other thicker, tougher tissues. While scalpels cut tissue precisely, they do not control bleeding. On the other hand, electrosurgical devices cut efficiently and control bleeding, but can cause extensive thermal damage to surrounding tissue. In cases where there is an unacceptable risk of collateral damage or scarring from electrosurgery, surgeons must use both a traditional scalpel for cutting, and an electrosurgical tool for coagulation.
The PlasmaBlade combines the precision of a scalpel with the bleeding control of an electrosurgical device.
The PULSAR Generator supplies pulsed plasma-medicated electrical discharges through the PlasmaBlade. Because radio frequency is provided in short on-an-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?C. This temperature reduction results in reduced heat transfer and half the damage to surrounding tissues compared with traditional electrosurgery devices.
John Tighe, PEAK Surgical, explained: “With the introduction of the PlasmaBalde, 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.”
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