Device to treat urinary incontinence gets nod

January 14, 2019 0 By FM

Atlantic Therapeutics said the US FDA 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.

FDA cleared the transcutaneous electrical stimulation continence device following the results of two randomized controlled trials demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence in adult females.

The data from its pivotal US trial showed 87.2% of patients were dry or mild after a 12-week treatment period, with 93% of patients experiencing improvement in just 4 weeks. This follows the presentation of data from an earlier placebo-controlled trial conducted in Europe that demonstrated significant improvement across all study endpoints.

Innovo’s Multipath technology uses electrical muscle stimulation to deliver 180 perfect and complete pelvic floor contractions to the entire network of pelvic floor muscles in every  30-minute session. It is designed to optimally strengthen the pelvic floor and re-educate the muscles that control bladder function.