PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in Expanded I...( PALO ALTO Calif. Dec. 17 /- PEAK Surg...),Health

PALO ALTO, Calif., Dec. 17 /PRNewswire/ -- PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PEAK(R) Surgery System for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. The company also announced that it has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAK Surgery System in plastic, gynecologic and oncologic surgery.

The PEAK Surgery System, which received FDA clearance for use in general surgery in July 2008, includes the PEAK PlasmaBlade(TM) family of disposable surgical cutting and coagulation devices. The PlasmaBlade tissue dissection devices are used in conjunction with PEAK's PULSAR(TM) Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. The PlasmaBlade offers the exacting control of a scalpel and the coagulation of traditional electrosurgery without causing extensive collateral damage. Since FDA clearance, surgeons in the United States have used the PlasmaBlade in nearly 350 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries.

"Because the PlasmaBlade cuts at a lower temperature than traditional electrosurgical devices, it reduces collateral tissue damage and scarring, which is important for patients undergoing plastic surgery procedures," said Dr. Howard L. Rosenberg, former chief of surgery at El Camino Hospital in Mountain View, Calif., and co-primary investigator of an ongoing clinical study evaluatin
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