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PEAK Surgical Announces Completion of First PRECISE Clinical Study, Receipt of Medical Design Excellence Award for PEAK(R) Surgery System and Achievement of Over 1,000 Surgeries Using PEAK PlasmaBlade(TM)
Date:4/7/2009

hospitals and clinics are cutting back their spending on surgical devices and patients are postponing elective procedures, we have seen significant uptake of the PlasmaBlade by surgeons," said John Tighe, president and chief executive officer of PEAK Surgical. "The fact that in just eight months, more than 1,000 patients have undergone surgical procedures with the PlasmaBlade is a testament to the benefits the technology provides to surgeons and patients, including improved surgical incision healing, minimal bruising, scarring and inflammation."

"The PlasmaBlade technology has been extensively validated through preclinical data, and I expect that the comprehensive clinical study program under way will confirm the positive patient outcomes we are seeing clinically," said Dr. Howard Rosenberg, former chief of surgery at El Camino Hospital in Mountain View , Calif., and co-primary investigator of the PRECISE abdominoplasty study.

Since the PEAK Surgery System was cleared by the U.S. Food and Drug Administration for use in general surgery and launched in July 2008 in the United States, PEAK Surgical has achieved several other milestones, including:

  • Introduction of two new products in the PlasmaBlade family, including the PlasmaBlade Needle, specifically designed for ultra-precise surgical procedures, and the PlasmaBlade EXT, designed for use in surgical procedures requiring an extended-reach tip;
  • Receipt of 510(k) clearance for the PEAK Surgery System to expand the indications to include cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures;
  • Receipt of European CE Mark approval for the PEAK Surgery System for use in general surgery.

Benefits of the PlasmaBlade and PULSAR Generator<
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SOURCE PEAK Surgical, Inc.
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