Bovie Medical Receives 510K Clearance for its J-Plasma® Precise Flex Handpiece

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The Addition of the J-Plasma® Precise Flex rounds out Bovie Medical’s J-Plasma® offering to include products designed for open and minimally invasive surgical procedures, including laparoscopic and robotic approaches

Bovie Medical (NYSE MKT:BVX) announced today that it has received 510K clearance from the FDA for a new J-Plasma® Precise Flex handpiece. The J-Plasma® Precise Flex handpiece is designed to be used in robotic-assisted procedures including those with Intuitive Surgical’s da Vinci Surgical System. The J-Plasma® Precise Flex includes Bovie Medical’s Cool-Coag™ 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.

The J-Plasma® Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps or grasping instruments and was designed to be used through an accessory port. When used in robotic-assisted procedures, the J-Plasma® Precise Flex can be controlled entirely from a surgeon’s console using a robotic grasper which allows a surgeon the ability to access and visualize a wide variety of surgical planes.

Vipul Patel, M.D., Medical Director of Global Robotics Institute at Florida Hospital Celebration Health states, “This new Precise Flex version of J-Plasma® offers surgeons the ability to use J-Plasma® in areas of the anatomy that otherwise couldn’t be reached with the laparoscopic version.” “Combining this flexibility with the Cool-Coag™ technology may also allow the surgeon to complete all aspects of cutting, coagulating and ablating tissue with one instrument potentially reducing the need to use other instruments,” ended Patel.

“The clearance of the J-Plasma® Precise Flex is an important milestone for our company as part of our strategy to increase utilization of our innovative technologies in robotic surgery,” said Robert L. Gershon, Chief Executive Officer. “This clearance comes on the heels of the recently announced 510k clearances of both our Cool-Coag™ generator and our new open handpiece; together, the J-Plasma® Precise Flex handpiece and Cool-Coag™ technology allows surgeons to benefit from using a single device that offers greater control of tissue effect while being able to switch to a monopolar or helium spray coagulation mode from the robotic console. We look forward to a commercial launch of this innovative technology for use in both open and minimally invasive surgical procedures, including laparoscopic and robotic approaches in the second half of 2017.”



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