FDA 510(k) Clearance for Bovie Medical’s PlazXact Ablator

Bovie Medical Corporation, a maker of medical devices and supplies and the developer of J-Plasma—a patented new surgical product—has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new bipolar ablator, branded PlazXact, a tool that offers surgeons precision and safety when performing arthroscopic procedures.
 
The PlazXact received clearance for the cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures, and will operate with a standard saline irrigation solution. The device’s efficient tip design results in lower saline temperatures, and it has the advantage of being compatible with standard electrosurgical generators found in ambulatory surgical centers and hospital operating rooms.
 
“This new product launch demonstrates our R&D capabilities around advanced energy products, and PlazXact, like other Bovie products, features a high level of precision combined with the additional safety of lower power requirements,” said Robert L. Gershon, chief executive officer. “We see an important market opportunity among orthopedic surgeons treating sports injuries and age-related joint damage, and we are confident that the PlazXact has the potential to become an important tool in a broad range of arthroscopic procedures. Currently, we are evaluating options for full commercialization of the product, including the potential for sales channel partnerships.”
 
“Over the course of the last two years, we have invested in further developing Bovie’s R&D capabilities to take advantage of opportunities within our existing product portfolio as well as to leverage our deep domain experience in the manufacture of advanced energy products. The PlazXact is our first entry into the arthroscopic surgery market, and we expect to launch additional growth products in 2017 and beyond,” Gershon concluded.
 
The PlazXact will be available with shaft diameters of 3.3mm, 2.4mm and 1.8mm, which will operate with electrode face angles of 90°, 50°, and 60° respectively. The 3.3mm models will be available in both aspirating and non-aspirating versions, while all others will be available as non-aspirating versions only.