The FDA granted a de novo clearance to Atlantic Therapeutics’ electrical muscle stimulator for women, for treating stress urinary (SUI) incontinence.
The externally worn Innovo device, the first transcutaneous stimulation device cleared by the FDA for incontinence, according to the company, can be prescribed as a primary therapy or after ineffective physical therapy, such as pelvic floor or Kegel exercises.
According to the Galway, Ireland-based Atlantic, a randomized sham-controlled trial showed it to be an effective, low-risk device, with 87.2% of U.S. patients seeing successful treatment after 12 weeks and 93% reporting improvements in four weeks.
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A second controlled study in Europe also demonstrated significant improvements, where the device has received a CE mark. The company reported over 1.5 million Innovo therapy sessions delivered in Europe with no device-related complications.
“For the first time, physicians in the U.S. can offer their patients a safe, clinically effective, noninvasive home-based treatment,” said Steve Atkinson, CEO of Atlantic, which estimated that one-third of all women in the U.S. are affected by SUI.
Previously, invasive treatments for SUI such as pelvic mesh implants have seen complications and thousands of lawsuits. In 2017, a jury awarded a patient $20 million in damages from Johnson & Johnson’s Ethicon business unit, after her TVT-Secur implant failed and eroded inside her body.
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The year before, J&J had set aside more than $120 million to settle the more than 40,000 lawsuits its facing from women alleging chronic pain and organ damage, in one of the largest examples.