Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, showcased their newly approved wearable device, INNOVO®, at the 2019 American College of Physicians (ACP) Internal Medicine Meeting held in April 2019 in Philadelphia, PA, and the 2019 American College of Obstetricians and Gynecology (ACOG) Annual Meeting held in May 2019 in Nashville, TN.
INNOVO® was approved by the United States Food and Drug Administration (FDA) on November 13, 2018, and is the first ever transcutaneous electrical stimulator cleared by the FDA, offering U.S. women a safe, clinically effective and non-invasive choice to treat stress urinary incontinence (SUI). In its pivotal multi-center randomized controlled clinical trial, 87.2% of INNOVO® users were dry or almost dry after a 12-week treatment period, with 80% of patients experiencing improvement in just 4 weeks.1
"Many people find that SUI gets in the way of their daily and social activities, and INNOVO® is a breakthrough treatment option that can provide relief for millions of women who are living with the burden of incontinence," said Gordie Nye, Chairman of Atlantic Therapeutics. "We are excited to be showcasing our new wearable product here in the US after a successful track record in Europe and sharing it with the professional community at these important meetings."
About one in three women suffer from SUI at some point in their lives.2 SUI occurs when urine leaks out from sudden pressure on the bladder and urethra from coughing, sneezing, laughing or exercising, causing the sphincter muscles to open briefly.2 SUI can happen at any age, but it is most common during pregnancy, post-childbirth and during stages of menopause.2
"SUI is a serious issue facing millions of women and until recently there have been limited treatment options available to those in need of care. We are excited that the INNOVO® device is becoming available as a new treatment option for patients in the U.S. so that they can finally find a treatment option that is right for them," said Steven G. Gregg, Ph.D., Executive Director, National Association For Continence (NAFC).