Bovie’s Cool-Coag generator and handpiece obtain FDA 510(k) clearance

28 March 2017 (Last Updated March 28th, 2017 18:30)

Medical device firm Bovie Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new J-Plasma generator and handpiece equipped with Cool-Coag technology.

Medical device firm Bovie Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new J-Plasma generator and handpiece equipped with Cool-Coag technology.

Cool-Coag technology features J-Plasma's increased accuracy with minimal thermal spread combined with capabilities of standard monopolar coagulation and helium spray coagulation.

The combination allows use of a single device for greater control of tissue effect as well as an option to switch to a monopolar or helium spray coagulation mode with 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."

Bovie Medical chief executive officer Robert Gershon said: "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.

“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.”

According to Memorial Sloan Kettering Cancer Center Ovarian Cancer Surgery head Dr Dennis Chi, the new technology has the potential to enhance the use of J-Plasma in several complex cancer procedures.

The device also facilitates usage close to vital structures with minimal collateral damage and standard full monopolar coagulation capability.

Estimated to be launched in the second half of this year, Cool-Coag  is expected to enable the use of J-Plasma in additional procedures and specialties.