Stress urinary incontinence clearance announced

Atlantic Therapeutics has announced that the Food and Drug Administration granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in women.

It is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, the company said, and follows studies demonstrating it as a low-risk treatment for stress urinary incontinence.

“INNOVO® therapy is a compelling treatment option for all those women who today simply suffer in silence from stress urinary incontinence,” said Steve Atkinson, CEO, Atlantic Therapeutics.

INNOVO® has been used in 1.5 million therapy sessions in Europe, the company said.

“INNOVO® is a major breakthrough for the millions of women who have to deal with the emotional and physical daily burden of incontinence,” said Gordie Nye, Chairman of Atlantic Therapeutics, “INNOVO® is the active solution for U.S. women who otherwise face a life wearing absorbent pads.”