FDA Clears InControl Medical’s Male Incontinence Treatment
InControl Medical has launched its InToneMV nonsurgical treatment for men with urinary or fecal incontinence throughout the U.S., following receipt of FDA 510(k) clearance, the company said Monday.
The device is a noninvasive rehabilitation program designed to strengthen weakened pelvic floor muscles and improve sphincter closure, all in the privacy of the home, the company said.
A customizable probe delivers muscle stimulation to the muscles of the pelvic floor, strengthening them and eliminating leakage. Patients complete exercises with the help of voice-guidance and get visual biofeedback that lets them know the exercises are being performed correctly, the company said. Data from each home-based session is recorded, allowing physicians to guide progress during monthly follow-up visits.
The predicate device on which InToneMV’s clearance was based was the original InTone, a Class II device for treating female urinary incontinence. InToneMV has a smaller design and can be used by men and women, the company said.
In clinical trials, 90-day use of the original InTone device reduced average daily pad usage and daily incontinence episodes by 56 percent and 77 percent, respectively. Twenty-four hour pad weight declined 87 percent, Colleen Baughn, director of clinical applications at InControl, told Device Daily Bulletin.
According to the Brookfield, Wisc., company, about 12 million men in the U.S. suffer from incontinence. — Kellen Owings
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