FDA Clears Bovie Medical’s Cool-Coag Generator and Open Handpiece

Bovie Medical announced that it has received 510(k) clearance from the FDA for a new J-Plasma generator and handpiece that incorporate Cool-Coag technology.
 
Cool-Coag is a new technology that combines the unique benefits of J-Plasma, namely increased precision with minimal thermal spread, with standard monopolar coagulation and helium spray coagulation capabilities, all in one handpiece. This allows the surgeon to benefit from using a single device that offers the greater control of tissue effect that J-Plasma delivers, while being able to switch to a monopolar or helium spray coagulation mode with just the push of a button.
 
“The development of Bovie’s Cool-Coag technology is a direct result of feedback from surgeons who have used our J-Plasma product for procedures that require greater coagulation capability, specifically in the areas of gynecologic oncology and surgical oncology,” said Robert L. Gershon, CEO. “The unique flexibility of Cool-Coag enables the surgeon to use J-Plasma to perform the most delicate procedures, where precision and low risk of injury to surrounding tissue are paramount and also have the full power of monopolar coagulation to control, pinpoint and diffuse bleeding as needed.”
 
“This new Cool-Coag technology has the potential to increase usage of the J-Plasma device in many of our most complex cancer procedures. It combines J-Plasma’s ability to be used close to vital structures with minimal collateral damage and standard full monopolar coagulation capability, all in one hand-held instrument. Cool-Coag may also expand the use of J-Plasma in additional procedures and specialties,” said Dr. Dennis Chi, head of the Ovarian Cancer Surgery at Memorial Sloan Kettering Cancer Center in New York City.
 
“We are pleased with our ability to continue to provide innovation that meets the needs of surgeons and are confident in the substantial growth opportunity for J-Plasma as we continue to penetrate the market,” Mr. Gershon noted.