One of the concerns patients with neurologic diseases such as multiple sclerosis face is decline or loss of bladder control. It can be an embarrassing and frustrating problem, which is estimated to occur in about 80% of MS patients, as the disease causes a slowing down or interruption in signal transmission to and from the brain. This, of course, gets in the way of efficient bladder innervation, which can manifest as urgency, incontinence, nocturia, or hesitancy.
Yesterday, the US Food and Drug Administration granted marketing approval for a revolutionary product from Redmond, Washington-based Vesiflo, Inc. indicated for female patients suffering from impaired detrusor contractility (IDC) — the reduced ability to contract the muscles needed to squeeze urine out of the bladder. The inFlow Intraurethral Valve-Pump is a replaceable urinary prosthesis, which has the potential to soon replace the need for other standard solutions for IDC, likecatheterization.
The deputy director for science and the chief scientist at the FDA’s Center for Devices and Rediological Health, William Maisel, M.D. M.P.H., explained that the device offers women with IDC a more convenient and mobile solution to urination by drawing urine from the bladder and blocking urine flow. The patient would only have to see a physician, get fitted for an inFlow device, and have it inserted. The device’s 4 components need replacing every 29 days, so as an option to having it inserted in a doctor’s clinic, the patient or a caregiver can receive proper training to perform the removal and insertion themselves.
The device garnered an FDA approval through the de novo classification process, which covers low to moderate risk devices, after a review of findings that showed 98% of the 115 female participants with IDC, using the inFlow device, retained post-void residual urine volumes similar to those who still used clean intermittent catheterization (CIC).
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