HHS NEWS

P97-6                           Food and Drug Administration
FOR IMMEDIATE RELEASE           Sharon Snider:    (301) 443-3285
February 14, 1997               
                                Consumer Affairs: (800) 532-4440


FETAL STENT RECEIVES FIRST "HUMANITARIAN USE" APPROVAL

     The Food and Drug Administration today granted the first
approval of a medical device under a new regulation that makes it
easier and less costly for manufacturers to bring to market
products for rare conditions or diseases -- those affecting fewer
than 4,000 people in the United States annually.
     The device is a fetal bladder stent, made by Cook OBGYN, of
Spencer, Ind., to treat urinary tract obstruction in unborn babies. 
The stent has been used on a limited basis for the past 15 years
for emergency situations and in FDA-approved clinical studies. 
Under the new Humanitarian Device Exemption (HDE) regulation, the
manufacturer is now approved to market the product commercially.
     "This regulation provides a new way for manufacturers of
devices for which there is a real need but too few patients to
justify a full-scale evaluation to get their product to market,"
said Bruce Burlington, M.D., director of FDA's Center for Devices
and Radiological Health.  "It will offer patients the benefits of
technological advances even when the market size is quite small." 
     Urinary tract obstruction occurs in fewer than 4,000 unborn
babies each year.  Until now the primary way to treat the condition
was by inserting a needle into the baby's bladder every couple of
days to withdraw urine.
     The new fetal bladder stent can be implanted into the baby's
urinary tract through the mother's abdomen via a needle guided by
ultrasound.  The stent remains in place, allowing urine to drain
from the baby's bladder to the amniotic cavity, for the duration
of pregnancy.  After birth, it is removed from the baby.  
     FDA approved the device based on a review of safety data
from a small clinical study submitted by the manufacturer, and on
the benefit to babies seen over the past 15 years of use.
     The manufacturer was required to show that the stent would
not expose the baby to any unreasonable risks, and that the
probable benefit of the stent outweighed the probable risks.  The
manufacturer also was required to show that there was no
comparable treatment available, and that without the HDE, the
company would not be able to bring the product to market.  
     Makers of new medical devices ordinarily must provide FDA
evidence from studies showing that products are both safe and
effective -- a requirement that involves controlled clinical
investigations.  The expense of such studies has been a
disincentive to medical device firms -- many of which are small -
- to develop products for rare conditions for which the market is
limited.  With HDE products, safety must be shown; however, the
manufacturer and FDA, with advice from a panel of experts, makes
a judgment of "probable benefit," rather than waiting for data
from clinical studies to establish effectiveness.
     An HDE approval contains a number of safeguards to ensure
patient protection.  For example, HDE devices may only be used in
medical facilities with local institutional review boards, where
the board has approved use of the device for the specific rare
condition or disease.  Also, an HDE approval is valid for only 18
months, but then can be extended in 18-month increments as long
as certain criteria are met.
     Device firms are also limited in how much they can charge
for the device, based on recovering costs of research,
development, manufacturing and distribution.
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