Med Device Monday: INNOVO – Therapy Device to Treat Stress Urinary Incontinence granted via the De Novo Pathway

Image from http://www.atlantictherapeutics.com/

Image from http://www.atlantictherapeutics.com/

Urinary incontinence is a very common, often ignored health issue. Stress incontinence is the most common type of urinary incontinence, and describes accidental leaks that occur when coughing, sneezing, laughing, jumping or doing heavy lifting. These simple movements, or stressors, put pressure on the bladder. Unfortunately, when the pelvic floor muscles are weak, this pressure can lead to a messy and potentially embarrassing leak. In women, stress urinary incontinence (SUI) can happen at any age, however it is most common during pregnancy, after childbirth, and during stages of menopause.

In November of last year, FDA granted a De Novo automatic reclassification to Atlantic Therapeutics’ INNOVO therapy device to treat stress urinary incontinence in women. INNOVO is a wearable device that may be prescribed as a front-line therapy to those suffering stress urinary incontinence, or as a second line therapy to those that previously failed physical therapy (in the form of supervised or unsupervised pelvic floor exercises, also known as Kegel exercises).

So, what exactly is a pelvic floor?

The term pelvic floor describes the group of muscles that span the bottom of the pelvis and support the pelvic organs. The pelvic organs in men (yes, men also have a pelvic floor) are the bladder and bowel, and in women they are the bladder, bowel and uterus. Weak pelvic floor muscles can lead to incontinence, pain, and prolapse, or the slipping down or forward of a pelvic organ. Honestly, we can’t think of anything good that comes from a weak pelvic floor.

According to the manufacturers, using a hand-held controller that is attached to a two-part garment, the INNOVO therapy device sends targeted impulses via conductive pads (attached to your upper thigh and buttocks) to activate the muscles of the pelvic floor. It is a technology that has been designed to optimally strengthen your pelvic floor with 180 contractions per session, allowing the device to do your pelvic floor exercises for you.

The device has demonstrated promising results. 87.2% of patients were dry or almost dry of after a 12-week treatment period, with 93% of patients experiencing improvement in as little as four weeks using the device five days a week for 30 minutes. One potential benefit of the device is that it is a transcutaneous electrical stimulator that offers a non-invasive choice to treat stress urinary incontinence. Elizabeth LaGro, Vice President of The Simon Foundation for Continence said it well, “INNOVO offers a new frontline therapeutic option for the millions of American women living with stress urinary incontinence, and in a significant group could delay or prevent the need for higher risk surgery or medical intervention.”

And finally, in addition to talking about a novel device coming soon to the US market, this week’s Medical Device Monday gives us the opportunity to again mention the De Novo pathway. In December, now outgoing FDA Commissioner Dr. Scott Gottlieb provided a high level description of the pathway; “the De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health”. In practice, the De Novo pathway is used for the review of novel, low to moderate risk devices for which there are ways to provide reasonable assurance of the device’s safety and effectiveness, but for which there is no existing predicate to use in the determination of substantial equivalence. So now, after years on the European market, women in the US will soon have access to INNOVO. We hope to see more US moms on trampolines in the near future!

Additional Reading:

1.      FDA Classification order

2.      Atlantic Therapeutics website

3.      Video explaining how INNOVO works

4.      Press release

5.      More info on SUI