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FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence

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

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ICS 2018: Atlantic Therapeutics Exhibit New Data Demonstrating Comparable Efficacy, Increased Tolerability and Reduced Infection Risk of its Non-invasive Device Innovo® in Treating Stress Urinary Incontinence

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

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A Revolutionary Design in Pelvic Floor Weakness Treatment

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