Uromedica said today it won a reimbursement code from the Centers for Medicaid and Medicare Services for its ProAct adjustable continence therapy for men, and that it launched the device in the US.
The ProAct system has FDA approval and is indicated for treating adult men with stress incontinence from intrinsic sphincter deficiency of at least 12 monst following radical prostatectomy or TURP who have failed ot respond to conservative therapy, the Plymouth, Minn.-based company said.
“The issuance of these codes will allow Uromedica to deliver its safe and effective therapy to improve the quality of life for men struggling with Stress Urinary Incontinence,” prez & CEO Tim Cook said in a press release.
The ProAct therapy system consists of 2 small adjustable silicone balloons connected with a tube to a filling port. The balloons are surgically placed in the area where the prostate was removed or resected, with ports hidden under the skin, Uromedica said.
The fluid-filled ballons are designed to provide pressure and support the bladder neck to prevent urine leaking and to help maintain normal bladder functionality. The balloon’s volume can be adjusted at any time, the company said.
“Twelve months after a prostatectomy, 1 in 4 men will still have their lives disrupted by SUI. ProACT is an adjustable balloon device designed to treat all severities of SUI in men. Given the minimally invasive nature of the procedure and the low risk profile, ProACT provides a therapeutic alternative to more invasive alternative procedures,” Cook said in a prepared statement.