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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

g the PlasmaBlade in abdominoplasty (or "tummy tucks"). "We expect that the clinical study underway at our hospital will demonstrate improved healing, reduced pain and less post-operative drain output (serous fluid) with the PlasmaBlade compared with electrosurgery."

"We have been impressed with the reduced tissue charring and the ability to work close to delicate and sensitive tissues with the PlasmaBlade, which is especially important in gynecologic procedures in which the bowel, ureter and ovaries are close by," said Dr. Fermin F. Barrueto, chief of endoscopy and pelvic reconstruction at Mercy Medical Center in Baltimore and primary investigator of an ongoing clinical study evaluating the PlasmaBlade in hysterectomies. "We expect that the clinical study we are conducting will show less collateral thermal injury to uterine tissue and less post operative pain, due to the lower temperature associated with the PlasmaBlade compared with traditional electrosurgery."

PRECISE Studies Launch Comprehensive Clinical Study Program

PEAK Surgical recently initiated two clinical studies in plastic and gynecologic surgery, with three additional studies in plastic, gynecologic and oncologic surgery planned. All will evaluate the operative performance and clinical results of the PlasmaBlade compared with traditional electrosurgery. Results from the five PRECISE Studies are expected in the first half of 2009.

"With the FDA clearance of expanded surgical indications and the initiation of our comprehensive clinical study program, PEAK Surgical is poised to drive adoption of the PlasmaBlade based on clinical outcomes," said John Tighe, chief executive officer of PEAK Surgical. "We have already seen significant adoption of the PlasmaBlade by U.S. surgeons, as they discover how easy it is to use and how precisely it cuts tissue and controls bleeding without causing extensive collateral thermal damage to tiss
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SOURCE PEAK Surgical, Inc.
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