Company introduces device for cutting and coagulation of soft tissue during otolaryngology surgery
PEAK Surgical, Inc. introduces the PEAK® PlasmaBlade TnA (Tonsil and Adenoid) tissue dissection device following 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new product is indicated for cutting and coagulation of soft tissue during otolaryngology (ear, nose and throat [ENT]) surgery, including removal of the tonsils and adenoids.
The PEAK PlasmaBlade™ is a family of disposable, low-temperature surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage to surrounding tissue. The PlasmaBlade is part of the PEAK® Surgery System, which also includes the PULSAR® Generator. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding.
In the United States, the PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. It was launched in the United States in July 2008 and has been used by U.S. surgeons on more than 2,000 patients, including general, gynecologic, and plastic and reconstructive surgeries.
PEAK Surgical has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAK Surgery System in plastic and reconstructive, ENT and oncologic surgery. Initial study results are expected later this year.