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news.Peak Surgical, a medical device company, has received the FDA 510(k) clearance to market its Peak surgery system for cutting and coagulation of soft tissue during plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures.
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The Peak surgery system, which received FDA clearance for use in general surgery in July 2008, includes the Peak PlasmaBlade family of disposable surgical cutting and coagulation devices. The PlasmaBlade tissue dissection devices are used in conjunction with Peak’s Pulsar generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding.
According to the company, the PlasmaBlade offers the exacting control of a scalpel and the coagulation of traditional electrosurgery without causing extensive collateral damage.
The company has also initiated a series of clinical studies, called the Precise studies to evaluate the use of the Peak surgery system in plastic, gynecologic and oncologic surgery.
John Tighe, CEO of Peak Surgical, said: “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.”