Bovie Medical Receives FDA 510(k) Approval for Bovie Ultimate™ Generator

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Bovie Medical Corporation
BVX
, a maker of medical devices and supplies, and the developer of J-Plasma®, a patented new surgical product, today announced that it has received FDA 510(k) approval for the Bovie Ultimate™ generator. The Bovie Ultimate™ is a high frequency electrosurgical generator that can be used for delivery of RF energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The generator offers users monopolar, bipolar and plasma features, including one J-Plasma® helium gas outlet, in a single generator. Its pad-sensing system reduces the risk of patient burns, but this feature is not required when using helium gas mode for soft tissue coagulation. The Bovie Ultimate™ will replace Bovie's ICON™ GS plasma system. “We are pleased to have received FDA approval for this leading edge product, which combines J-Plasma® technology with the highest wattage operating room electrosurgical generator,” said Robert L. Gershon, Chief Executive Officer. We designed the Bovie Ultimate™ to provide medical practitioners with greater flexibility, including the ability to easily incorporate our J-Plasma® product. This is an excellent illustration of our strategy to leverage synergies between our core product and J-Plasma® businesses to drive future revenue growth.” The Company expects commercial launch of the new product in February, 2015.
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