PALO ALTO, Calif., Jan. 28 /PRNewswire/ — PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced today that it has received European CE Mark approval for its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System includes the PULSAR(TM) Generator and the PEAK PlasmaBlade(TM) family of disposable, low-temperature surgical cutting and coagulation devices. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding.
PEAK Surgical received 510(k) clearance from U.S. Food and Drug Administration (FDA) in July 2008 for the PEAK Surgery System for use in general surgery and in December 2008 for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. To date, surgeons in the United States have used the PlasmaBlade in more than 500 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries.