ST. LOUIS, June 8 /PRNewswire/ -- Mallinckrodt Inc. (NYSE: MKG) has
acquired the exclusive worldwide rights to intrauterine sensor technology
patented by Dr. Jason Gardosi of Nottingham, England. The company plans to
integrate this technology into its next generation of Nellcor fetal pulse
oximetry sensors.
The Gardosi-designed sensor features a balloon which, when inflated with
saline, "wedges" the fetal sensor between the uterine wall and the fetal head.
This wedging action secures the sensor in place during labor and delivery,
greatly reducing the need for a clinician to reposition the sensor as the
fetus moves.
Mallinckrodt plans to integrate the new sensor technology into its N-400
fetal pulse oximetry system, currently available outside the United States.
The N-400 provides real-time measurements of oxygen levels in fetal arterial
blood during active labor using the Nellcor FS-14 intrauterine sensor.
Studies have shown that fetal pulse oximetry reduces the need for collecting
scalp blood pH samples from some fetuses during labors in which the fetal
heart pattern is non-reassuring. Studies also have indicated that the
technology may have further potential to reduce C-Sections associated with
non-reassuring fetal status.
"The expandable intrauterine sensor has the potential to substantially
augment our current fetal pulse oximetry technology," said John Hesemann,
president of Mallinckrodt's Respiratory Group. "In addition, our evaluation
of the Gardosi design suggests that it may enable multiple measurements, such
as fetal oxygen saturation, fetal heart rate and intrauterine pressure from
one fetal sensor.
Dr. Gardosi stated, "Mallinckrodt's leadership in developing fetal pulse
oximetry technology will help accelerate the commercial development and
adoption of the expandable intrauterine sensor. In turn, the new sensor
should help the clinical application of fetal pulse oximetry and speed its
acceptance as a modern method for monitoring fetal well-being during labor."
The Mallinckrodt acquisition gives the company worldwide patent protection
over any sensor designed to create a wedge between a uterine wall and the
fetus through a balloon, sponge or any other expandable means.
Mallinckrodt's Nellcor Perinatal Business has recently completed a
multisite, randomized-controlled clinical trial in the United States in
preparation for a PMA submission to the U.S. Food & Drug Administration (FDA)
for the N-400 fetal oximetry system. Design and operation of the N-400 fetal
oximeter is based on the proven Nellcor pulse oximetry technology used in
other clinical areas for many years.
The fetal oxygen sensor is non-invasive to the fetus and minimally
invasive to the mother. The N-400 system has been in use in Europe since 1995
and has monitored more than 20,000 fetuses worldwide.
Mallinckrodt Inc., based in St. Louis, Missouri, has three healthcare
product groups -- Imaging, Pharmaceuticals and Respiratory. The company
operates in more than 100 countries and had fiscal 1998 net sales of
$2.4 billion. In August 1997, Mallinckrodt acquired Nellcor Puritan Bennett
(NPB), the world's leading producer of pulse oximeters and sensors, and with
the integration of NPB, with its critical care division, has maintained the
global leadership position in pulse oximetry. The Mallinckrodt website
address is http://www.mallinckrodt.com.
CONTACT: Media, Barbara Abbett, 314-654-5230, or e-mail,
Communications@mkg.com, Investors, Barbara Gould, 314-654-3190,
or e-mail, Invest@mkg.com, or Perinatal, Debra Reisenthel,
925-463-4514, or e-mail, debbie.reisenthel@mkg.com
SOURCE Mallinckrodt Inc.
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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, Communications@mkg.com, investors, Barbara Gould,
314-654-3190, or e-mail, Invest@mkg.com, or perinatal, Debra
Reisenthel, 925-463-4514, or e-mail, debbie.reisenthel@mkg.com,
all for Mallinckrodt Inc.
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