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news.Peak Surgical, a medical device company, has received the European CE Mark approval for its Peak surgery system for use in general surgery.
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The Peak surgery system includes the Pulsar generator and the Peak PlasmaBlade 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, the company said.
Peak Surgical has recently initiated a series of clinical studies, called the Precise studies, to evaluate the use of the Peak surgery system in plastic and reconstructive, gynecologic and oncologic surgery.
Peak Surgical’s pulsed plasma-mediated discharges and electrode insulation techniques were originally invented at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University and developed by Peak Surgical.
John Tighe, president and CEO of Peak Surgical, said: “We are pleased that the European authorities have approved the use of the Peak surgery system. We look forward to commercializing this innovative device in Europe, where we believe the PlasmaBlade could eventually be used in more than one million surgical procedures each year.”