Advisory panel to review Mallinckrodt's PMA application this month
ST. LOUIS, Jan. 11 /PRNewswire/ -- Mallinckrodt Inc. (NYSE: MKG) said
today that its premarket approval (PMA) application for a new fetal oxygen
saturation monitoring system, OxiSure(TM), has been accepted for filing by the
Food and Drug Administration (FDA). An advisory panel will review the
application in late January and make a recommendation to the FDA on whether
the application should be approved. Subsequently, the FDA will review and
make a decision on the application.
The OxiSure Fetal Oxygen Saturation Monitoring System is designed to
enable obstetricians to directly measure, for the first time, the arterial
oxygenation of a fetus during labor and delivery. Using technology derived
from Mallinckrodt's market-leading Nellcor-brand pulse oximeters, the OxiSure
system comprises a non-invasive fetal sensor containing red and infrared light
sources connected to a monitor that displays the percentage of oxygen in the
fetal blood in real time.
Currently, clinicians rely on fetal heart rate (FHR) monitoring as the
primary decision support tool during labor and delivery. A normal FHR pattern
reliably indicates a baby that is tolerating the stresses of labor. However,
many labors exhibit nonreassuring FHR patterns, suggesting a problem and often
leading to interventions that are subsequently found to have been unnecessary.
Mallinckrodt Chief Medical Officer Oye' Olukotun, M.D., said, "The fetal
oximetry monitoring system is just another example of how Mallinckrodt is
working to improve healthcare for patients worldwide. OxiSure is a new
monitoring system for use during labor and delivery that provides reassurance
to the obstetrician, nurse and mother that the baby is adequately oxygenated
and labor can safely continue."
According to John Q. Hesemann, president of the company's Respiratory
Group, the OxiSure system has the potential to benefit 30 to 40 percent of
births where an abnormal fetal heart rate is present at sometime during labor.
It is estimated that nonreassuring FHR occurs in over 1.6 million deliveries
in the United States each year. The OxiSure system has already been used in
the delivery of over 30,000 babies in Europe and parts of Asia, where the
product has been marketed by the Nellcor Perinatal business since 1996,
following 10 years of research and development.
To support the PMA application, Tom Garite, M.D., professor and chairman
of the Department of Obstetrics and Gynecology, University of California at
Irvine, led a randomized clinical trial of the OxiSure technology at nine
United States centers. The results from the clinical trial will be presented
to the Society of Maternal and Fetal Medicine Conference in Miami on February
3, 2000.
Mallinckrodt Inc. is a global manufacturer and marketer of healthcare
products. Based in St. Louis, Missouri, the company has three product
groups -- Respiratory, Imaging and Pharmaceuticals; had fiscal 1999 net sales
of $2.6 billion and operates in more than 100 countries. Mallinckrodt's
Respiratory Group develops, manufactures and markets products that help
diagnose, monitor and treat respiratory and anesthesiology patients across the
continuum of care. The Respiratory Group is a world leader in pulse oximeters
and sensors, airway management products, ventilators and alternate care
products. The Mallinckrodt website address is (http://www.mallinckrodt.com ).
CONTACT: Media, Barbara Abbett, 314-654-5230, or e-mail,
barbara.abbett@mkg.com, or Investors, Barbara Gould, 314-654-3190, or e-mail,
Invest@mkg.com, both of Mallinckrodt Inc.
SOURCE Mallinckrodt Inc.
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Related links:
http://www.mallinckrodt.com
Company News On-Call:
http://www.prnewswire.com/comp/440950.html or fax,
800-758-5804, ext. 440950
CONTACT:
Media, Barbara Abbett, 314-654-5230, or
e-mail, barbara.abbett@mkg.com, or Investors, Barbara Gould,
314-654-3190, or e-mail, Invest@mkg.com, both of Mallinckrodt
Inc.
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