Urology: Redefining the Standards of Care
Serving the aging US demographic is a golden opportunity for urology device companies. However, at this year's meeting of the American Urological Association, the field concentrated more on consolidation of older techniques than on breakthrough technologies.
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Urinary incontinence is a growing health problem with increasing social and economic significance--the direct and indirect costs of treating it total almost $20 billion in the US alone. Device companies are providing a variety of treatment options for patients with UI, including a growing number of increasingly less invasive surgical options.
Directed energy device-based medical therapies have greatly influenced the way physicians deliver care in a number of medical specialties. One of the most dramatic areas of change has been in the management of benign prostatic hyperplasia, commonly referred to as an enlarged prostate. DE treatments in this area have become so popular there has been a noticeable decline in once standard surgical therapies since the late 1990s as patients have migrated to these less-invasive alternatives. This expansion in BPH DE-based therapies is being driven not only by a shift toward less-invasive treatment options, but also by the rising number of patients susceptible to prostate ailments.
Novasys Medical is using radio frequency (RF) energy to treat stress urinary incontinence in women. The company chose to adopt a much more rigorous and expensive clinical trials strategy than was needed to gain FDA approval of its device. This approach flummoxed the FDA,, slowing approval of the company's IRenessaI system. Novasys is betting that the enhanced data collected from its clinical study will result in the company gaining faster reimbursement that it hopes will drive adoption.