Atlantic nets de novo clearance for pelvic floor muscle stimulator for urinary incontinence
Questex LLC | November 14, 2018
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 the 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. 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.