Bovie Medical obtains FDA 510(k) clearance for PlazXact ablator

16 August 2016 (Last Updated August 16th, 2016 18:30)

US-based medical device company Bovie Medical has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its bipolar ablator, PlazXact.

US-based medical device company Bovie Medical has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its bipolar ablator, PlazXact.

The PlazXact ablator is a sterile, single-use device to cut, coagulate and ablate soft tissues.

Used during arthroscopic surgical procedures, the device can operate with a standard saline irrigation solution.

"We are confident that the PlazXact has the potential to become an important tool in a broad range of arthroscopic procedures."

The tip of the device is designed to allow lower saline temperatures and is compatible with standard electrosurgical generators found in ambulatory surgical centers and hospital operating rooms.

It features a patented, wedge-shaped electrode shape which increases its access and visibility during a procedure.

Bovie Medical CEO Robert Gershon said: “This new product launch demonstrates our reasearch and development 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.

“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 commercialisation of the product, including the potential for sales channel partnerships.”

The PlazXact ablator features in shaft diameters of 3.3mm, 2.4mm and 1.8mm, which is designed to operate with electrode face angles of 90°, 50° and 60° respectively.

The 3.3mm configuration of the device will be available in both aspirating and non-aspirating versions, while all others will be available as non-aspirating versions.