510(k) For Bovie’s Patented J-Plasma™ Technology

Abstract

Electrosurgical products company Bovie Medical Corporation, has announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery. The handpiece will be powered by Bovie’s GS electrosurgical generator, which has prior 510(k) market clearance.

Background

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 has recently been granted a US patent for a “Method to generate a plasma stream for performing electrosurgery”, adding to the Company’s J-Plasma™ patent portfolio. Bovie has four patents related to its J-Plasma™ technology with three additional patent applications pending.

Planned introduction

The Company, assisted by leading surgeons, will introduce J-Plasma™ at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year by its independent sales distribution network.

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

The press release issued on February 1st makes no mention of the company’s plans in Europe nor the CE status of the device.

Company comments

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

Source: Bovie Medical Corporation