Bovie Medical Gets 510(k) Nod for New Cutting and Coagulation Tool

Bovie Medical Corp., a manufacturer and marketer of electrosurgical products, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its J-Plasma handpiece with retractable cutting feature for soft tissue coagulation during surgery. The handpiece is powered by Bovie’s GS electrosurgical generator, which already has 510(k) clearance.

J-Plasma is formed by passing an inert gas, such as helium, over a sharp conductive point which is held at high voltage and high frequency, producing a luminous discharge beam. The sharp conductive point can also be in the form of a retractable surgical blade, providing multiple modes of operation in a single instrument. The extended surgical blade can be used for incisions and other cutting procedures, and when retracted, the blade is used to form the J-Plasma beam for coagulation. The extended blade can also be used in combination with the J-Plasma beam, providing an enhanced cutting capability with minimal impact on surrounding tissue.

The company, assisted by leading surgeons, will introduce the device at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year.

Bovie continues to explore and review added applications for J-Plasma, including gynecology, dermatology, plastic surgery, infection control, use in robotics and other surgical techniques.

“This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace,” said CEO Andrew Makrides,

Bovie recently received a United States patent for a “Method to generate a plasma stream for performing electrosurgery,” which adds to the J-Plasma patent portfolio. This brings the total to four patents related to J-Plasma, with three additional patent applications pending.