Bovie bags FDA clearance for surgical device

FDA
Bovie hopes the FDA 510(k) will expand use of its J-Plasma technology.

FDA has granted 510(k) clearance to Bovie Medical’s revamped J-Plasma generator and handpiece. The model combines the J-Plasma technology Bovie sees as a more precise way to perform procedures with the more powerful monopolar coagulation approach.

Bovie has racked up multiple 510(k) clearances for J-Plasma-based products in recent years, making the surgical technology an emerging growth driver for the company. But its most recent FDA nod is for a device designed to give surgeons access to the best features of other coagulation approaches, namely monopolar and helium spray modes.

Surgeons using the generator and accompanying handpiece can access all three modes, in theory allowing them to pick the best tool for each task.

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Feedback from surgeons drove development of the multi-mode technology. In particular, surgical and gynecological oncology specialists told Bovie they need coagulation capabilities beyond those delivered by J-Plasma. By providing precision and power modes in one handheld instrument, Bovie hopes it can increase use of its devices among people previously put off by the lack of coagulation grunt.

Monopolar coagulation, like J-Plasma, is a radiofrequency-based approach to surgery. By pairing a generator to an active electrode built into a handheld instrument, monopolar electrosurgical devices deliver electric current to coagulate blood.

J-Plasma is designed to offer greater precision than such approaches by combining radiofrequency energy and helium plasma. The plasma is included to focus the radiofrequency energy, cutting the risk of injuries to non-target tissues.

Bovie sold $3.5 million worth of J-Plasma products last year. That amounted to less than 10% of the company’s total revenue for the year. But, with J-Plasma sales growing by 167% year on year, the technology is central to the company’s growth plans. The latest product is designed to further these plans by removing a barrier to its use by certain surgeons.

Memorial Sloan Kettering Cancer Center’s Dennis Chi, M.D. thinks Bovie can realize this ambition.

“This new Cool-Coag technology has the potential to increase usage of the J-Plasma device in many of our most complex cancer procedures,” Chi said in a statement. “It combines J-Plasma’s ability to be used close to vital structures with minimal collateral damage and standard full monopolar coagulation capability.”

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