Mallinckrodt Clears Critical Hurdle for New Obstetrical Product
ST. LOUIS, Jan. 27 /PRNewswire/ -- Mallinckrodt (NYSE: MKG) reports that
the U.S. Food and Drug Administration (FDA) Obstetrics and Gynecology Advisory
Panel recommended approval with conditions for its fetal oxygen saturation
monitoring system, Model N-400. Upon the FDA's completion of review of the
Pre-Market Approval (PMA) and Advisory Panel recommendation, it will make its
decision on the PMA.
The Advisory Panel voted 10-1 in favor of the system following public
testimony and presentations by Mallinckrodt and its clinical investigators
reporting on 10 years of development and clinical studies. The conditions
accompanying the panel's recommendation pertain to labeling details and
post-market studies of the product.
Debra Reisenthel, general manager of Mallinckrodt's Nellcor Perinatal
Business, said, "The panel's recommendation is extremely important because the
FDA usually follows the panel's guidance. We are hopeful that the FDA will
complete its review quickly and issue approval."
This new system, used in labor and delivery, measures the fetal oxygen
saturation by pulse oximetry (FSpO2) in the mother's womb. When used with
traditional fetal heart rate monitoring, a reassuring FSpO2 permits the
continuation of labor during periods of non-reassuring fetal heart rate and
results in an important reduction of Cesarean deliveries for fetal distress.
Approximately one-third of the 4 million annual births in the United States
develop a non-reassuring fetal heart rate sometime during labor.
Commenting on the system's potential benefits, Thomas Garite, MD, the
principal investigator and architect of the nine-site U.S. clinical study
said, "The value of this technology is in helping to resolve the current state
of ambiguity about fetal condition that often surrounds the birth process.
The N-400 should enable us to do the right thing, for the right reason, at the
right time -- and that should be very good for babies, mothers, and doctors."
The N-400 system consists of a sterile optical sensor and a monitor. It
uses technology from Mallinckrodt's market-leading Nellcor-brand pulse
oximeters to measure the baby's oxygen saturation by pulse oximetry in the
mother's womb in real-time during labor and delivery.
Mallinckrodt expects that the system will soon be available for sale in
the U.S. The product has been available in Europe and Asia since 1996 and is
also sold in Canada. More than 35,000 babies have been monitored with the
system.
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; it 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, e-mail,
Invest@mkg.com, both of Mallinckrodt Inc.
SOURCE Mallinckrodt Inc.
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http://www.mallinckrodt.com
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http://www.prnewswire.com/comp/440950.html or fax,
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Contact: Media, Barbara Abbett, 314-654-5230, or e-mail,
barbara.abbett@mkg.com, or Investors, Barbara Gould,
314-654-3190, e-mail, Invest@mkg.com, both of Mallinckrodt Inc.
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