Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.
Source: Yahoo! Finance, February 6, 2020
“OMG. I just free’d myself!” Today, 20 million women in America will rewrite that whispered, uncomfortable admission of bladder weakness1 into a declarative, celebratory shout thanks to INNOVO®. As the first-in-class wearable, non-invasive solution for Stress Urinary Incontinence (SUI), INNOVO has the potential to positively impact the lives of one in three women.2 These women will now be able to laugh louder, exercise harder and even sneeze with ease. The INNOVO thigh-length, elasticized therapeutic shorts are outfitted with eight electrodes sewn in a crisscross formation across the pelvic region. When activated via its attached hand-held controller, INNOVO delivers a series of pelvic stimulations equivalent to Kegel exercises for strengthening the pelvic floor. Read more.
Source: PRNewswire, June 5, 2019
Atlantic Therapeutics, a company out of Galway, Ireland, will soon be releasing its INNOVO transcutaneous electrical stimulator to treat stress urinary incontinence in women. The device was FDA approved late last year as the first transcutaneous stimulator with such an indication. It delivers electric current through the body toward muscles that control the pelvic floor, which in turn can help maintain continence. The technology provides women a non-invasive option that, in a clinical trial, demonstrated that 87% of women were dry or nearly so after a three month treatment. 80% of the women studied had results after only a month or therapy. Read more.
Medgadget, April 11, 2019
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today (13.11.18) that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females. INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females. Read more.
Source: Business Wire, November 13, 2018
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, exhibits data highlighting comparable safety and efficacy of its INNOVO® therapy, an externally worn electrical muscle stimulation device for the treatment of stress urinary incontinence, with greatly reduced risk of infection and improved user tolerability over existing intravaginal probe devices1. Presented as a poster at the 48th Annual Meeting of the International Continence Society, the data was the result of an FDA designed clinical trial, with patients whose condition had not improved using pelvic floor muscle training. Supporting Atlantic Therapeutics’ FDA approval via the De Novo route for INNOVO®. Designed for at home use and worn as a close-fitting pair of shorts, INNOVO® was compared with an existing FDA approved intravaginal stimulation product as control. Read more.
Source: PRNewswire, August 28, 2018
It’s more common than hay fever, yet women just don’t talk about pelvic floor weakness, a condition resulting in intermittent urinary leakage. It affects one in three women in varying degrees of severity — 82% consider their symptoms severe, while 70% wear absorbent pads to deal with it. Yet, 68% of women never seek medical help. “Women are embarrassed. It’s called stress urinary incontinence and they associate the word ‘incontinence’ with old ladies being wet all the time,” says Dr Ruth Maher, an associate professor at the Department of Physical Therapy, Creighton University in Omaha. Maher is one of the original four inventors of recently launched innovotherapy, a non-invasive treatment for pelvic floor weakness. Innovotherapy directly targets pelvic floor weakness — the root cause of urinary leaks — unlike many other treatments which simply mask symptoms. Read more.
Source: The Irish Examiner, April 3, 2017