NAFC supports PMAA of Uromedica's ACT device for SUI, speaks to FDA

On March 24, Nancy Muller, executive director of The National Association For Continence (NAFC), spoke to the Food and Drug Administration (FDA), in support of a Premarket Approval Application (PMAA) of Uromedica, Inc.'s Adjustable Continence Therapy (ACT®) device to approve its usage in the U.S. The ACT is designed to treat female stress urinary incontinence (SUI).

Since 2002, two Uromedica minimally invasive post-operatively adjustable devices, the ACT and the ProACT™ (a similar technology for use in incontinent men), have been available in Europe, Australia, Canada and selected countries in Asia and South America, with over 3,000 ACT implants and approximately 7,000 ProACT implants to date and no reports of serious adverse events. The difference in the ACT and ProACT (women and men, respectively) is the four to six centimeter longer tubing for the men. Everything else is identical.

The ACT® device consists of an inflatable balloon connected to a subcutaneous filling port. Once the complete device is implanted, the device can be post-operatively adjusted through the skin with a small gauge needle in an office setting with no further surgery. Based upon the patient's individual needs, fluid can be added or withdrawn from the balloon via the subcutaneous filling port either during the surgery or years later. The ACT device protects against unintentional urine leakage by applying increased pressure to the bladder and keeping the patient dry. This device can be repeatedly adjusted as needed for optimal functionality for the patient.

"Stress urinary incontinence is the most common type of incontinence in women younger than 60," stated Muller to the FDA panel. "From the phone calls, letters and e-mails we receive daily, at our national headquarters, I can attest to the fact that women limit their activities, as a result of symptoms, placing them at risk of isolation, depression and an unhealthy sedentary lifestyle. We must offer these sufferers an acceptable alternative between irreversible, problematic surgery and 'Kegels.' Approval by the FDA [for ACT] will help put a safe, simple and minimally invasive treatment for recurrent female SUI in reach to women who would otherwise simply give up following surgical failures."

For the past nine years, Uromedica has continually established assurance of safety and effectiveness through pre-clinical, biocompatibility and human clinical data for the ACT device. The company has great hopes that the FDA will approve this device based on existing evidence without further delay.

SOURCE National Association For Continence


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