Published on March 12, 2010 at 12:51 AM
Covidien (NYSE: COV), a leading global provider of healthcare products,
today announced that the U.S. Food and Drug Administration (FDA) and
Health Canada have approved the use of the Maria Research Reactor
(Maria) in Poland as a site to irradiate highly-enriched uranium targets
for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99
obtained from Maria in the manufacture of its Technetium 99m (Tc 99m)
generators. Patients should begin to benefit from Maria-produced Mo 99
in the United States and Canada later this month.
“Their actions are great news for
patients who may have been facing longer delays in receiving critical
nuclear medicine diagnostic procedures.”
Tc 99m is a vital medical isotope used in over 80 percent of all nuclear
medicine diagnostic and functional studies of organs and anatomical
systems. The information from these studies is used by many medical
specialists (including radiologists, nephrologists, oncologists and
cardiologists) to better diagnose and treat patients. More than 35
million nuclear medicine procedures are performed worldwide each year,
more than half in the United States.
On February 17, 2010, in Warsaw, Poland, Covidien and the Institute of
Atomic Energy in Poland (IAE POLATOM) announced an agreement for Maria
to begin supplying Mo 99. At the time, it was estimated that the Mo 99
supplied from Maria would help meet the needs of more than one million
additional patients worldwide in just the first six months.
“We are pleased that both FDA and Health Canada expedited their reviews
of our data, resulting in a quick approval,” said Timothy R. Wright,
President, Pharmaceuticals, Covidien. “Their actions are great news for
patients who may have been facing longer delays in receiving critical
nuclear medicine diagnostic procedures.”
Source COVIDIEN