Medtech Solutions For The "Other" Incontinence
This article was originally published in Start Up
Fecal incontinence is a common, devastating condition that often goes untreated. Eyeing the potential multibillion-dollar opportunity, medtech start-ups are developing approaches that range from small and disposable to surgical and permanent.
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Endo International plans to shutter its Astora Women's Health business unit – formerly part of American Medical Systems – this month due to ongoing legal concerns tied to the company’s vaginal mesh products. What’s unclear is what this means for the company’s investigational fecal incontinence treatment, which received unanimous support from an FDA advisory panel just days before the shutdown was announced.
Neuromodulation for urological indications, notably overactive bladder (OAB), has been dominated since the late 1990s by Medtronic’s sacral-nerve stimulation system InterStim, with the more recent addition of Cogentix Medical’s Urgent PC for tibial nerve stimulation. Yet only a fraction of OAB patients receive effective neuromodulation treatment, and several companies hope to lower barriers to this modality by developing alternative devices for urological indications.
With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.