Brookfield-based InControl Medical LLC has received FDA clearance to sell its Apex Device over-the-counter and without a doctor’s prescription. Apex cures stress incontinence for the one in three women living with bladder leakage by strengthening the muscles of the pelvic floor, thereby eliminating the need for pads or diapers.
“Now millions of women can stop buying bladder leakage pads,” said Herschel Peddicord, president of InControl Medical. “Apex is a scientifically designed device that was previously sold only in physicians’ offices by prescription, and represents a significant leap forward for women’s health freeing them from reliance on inconvenient and expensive pads.”
Women are often told to do Kegel exercises, but Peddicord said they experience difficulty completing these exercises correctly, resulting in no benefit in strengthening the pelvic floor. Apex, however, is said to stimulate and strengthen the appropriate muscles, similar to a personal trainer for one’s pelvic floor.
InControl Medical received ISO 13485 certification and the CE mark of the European Commission, meeting comprehensive quality management requirements in the design and manufacture of medical devices.
