|InControl's InToneMV device for bladder leakage--Courtesy of InControl|
InControl Medical gained 510(k) clearance from the FDA on May 27 to market its InToneMV pelvic floor rehabilitation program to prevent male urine and bowel leakage.
InControl said in a statement that the device "is designed to address the complexities of the pelvic floor, strengthen weakened musculature and improve sphincter closure, all within the comfort and privacy of home."
The device contains a muscle stimulation probe and remote enabling customization of settings. The company says the device gives users voice-guided exercises and visual biofeedback. InToneMV may be purchased on the company's website for $795 with a faxed order from a physician, who must program the device.
The company also makes devices to prevent bladder leakage and promote pelvic health in women. They are a welcome alternative to lawsuit- and side effect-plagued vaginal mesh, and available internationally, including in Canada and Australia.
"It's terribly embarrassing for both men and women to have to live with fecal and urinary incontinence and even worse to have to resort to diapers, pads, meds or a surgical implant," said InControl founder and CEO Herschel Peddicord in a statement. "InToneMV works. Men no longer need to suffer with fecal or urinary incontinence."
InControl says 12 million American men have urinary or fecal incontinence.
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