InControl Medical Gains FDA Clearance for InTone MV Device

InControl Medical LLC, a women’s health company focusing on female urinary incontinence, has received U.S. Food and Drug Administration (FDA) clearance for its proprietary, patented InTone MV, a device that provides women who suffer from vaginal atrophy a smaller, more comfortable medical device for the treatment of stress, urge and mixed female urinary incontinence without surgery or drugs.

The InTone MV technology was developed by the makers of InTone, a Class II medical device for the treatment of female urinary incontinence.

“While InTone has helped countless women solve the embarrassing and uncomfortable issue of involuntary loss of urine, InTone MV allows us to help an even greater number of women who experience vaginal atrophy,” said Herschel Peddicord, InControl’s founder and CEO. “Vaginal atrophy is a common complaint among menopausal women or those who have had a vaginal hysterectomy. Often atrophy is accompanied by incontinence and InControl recognized the need for a smaller device designed just for them.”

Both the InTone and InTone MV devices combine muscle stimulation with voice-guided pelvic floor exercise, visual biofeedback, and a unique, customizable probe to create a home-based treatment for incontinence. This approach provides users with an easy-to-use program without pain, pills or side-effects, the company noted. In addition, InTone sends a calming signal to the detrusor muscle to decrease spasm and retrains the muscle to create more functional voiding.

InControl Medical LLC develops and markets solutions for women’s urinary incontinence including InTone, Apex and Intensity. The company is based in Brookfield, Wis.