Atlantic Therapeutics has received De Novo clearance for its electrical stimulator treatment for stress urinary incontinence (SUI).
The FDA clearance covers a wearable, garment-based device, Innovo, designed to modulate pelvic floor nerves and thereby strengthen the muscles involved in SUI.
Atlantic is pitching Innovo as an alternative to transvaginal stimulation devices, but it failed a non-inferiority test in a pivotal U.S. clinical trial.
SUI is defined by the unintentional release of urine as a result of pressure on the bladder, as happens during coughing, running and heavy lifting. Estimates of the proportion of women who suffer from some form of urinary incontinence worldwide range from 25% to 45%.
A range of treatment options, from pelvic floor exercises up to surgical procedures, are available to women with SUI. However, there is still a need for non-invasive treatments that work for all women, many of whom struggle to adhere to muscle exercise regimes. Companies have sought to address this need with devices that use electrical stimulation to strengthen pelvic muscles.
Some of the devices consist of a tampon-shaped probe that is inserted into the vagina. In the case of TensCare's itouch Sure, the device Innovo was compared to in the pivotal trial, the probe should be used 20 minutes a day for two months.
Atlantic set out to make a more convenient device, leading to the development of shorts that deliver electrical stimulation and are worn for 30 minutes a day. Atlantic has now received FDA clearance for the device. Innovo can now be prescribed as front-line therapy in SUI, or as a second-line treatment in people who have tried physical therapy without success.
FDA cleared the device on the strength of a pivotal clinical trial that compared Innovo to iTouch Sure in 180 women with SUI. The trial looked at the proportion of women who achieved a 50% reduction in pad weight over the course of the 12-week study. The pad weight test measures urine loss.
Atlantic aimed to show Innovo is as effective as iTouch Sure but fell short of that bar. With 56.3% of women in the Innovo arm achieving a 50% drop in pad weight, the trial failed to show non-inferiority to iTouch Sure and therefore missed its primary endpoint. Sixty-three percent of users of TensCare's device achieved a 50% reduction in pad weight.
Innovo performed comparably to iTouch Sure against a range of secondary endpoints, though. After 12 weeks, 87.2% of women in the Innovo cohort had dry or mild SUI, compared to 86.6% of people in the iTouch Sure arm.