PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Gener...( - Tissue Dissection System Represent...)

- Tissue Dissection System Represents Important Advance in Radiofrequency

Surgical Technologies -

PALO ALTO, Calif., July 24 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System combines the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month.

"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," said John Tighe, chief executive officer of PEAK Surgical.

In preparation for the commercialization of the PEAK Surgery System, the company launched a redesigned corporate Web site, which can be accessed at http://www.peaksurgical.com. The Web site provides detailed information about all of the components of the PEAK Surgery System, including a cart and wireless foot switch, as well as video, a brochure, fact sheets, product images, scientific literature and surgeon testimonials, among other information.

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
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