ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of
medical devices and related software solutions, announced today that it
has received 510(k) clearance from the U.S. Food and Drug Administration
to market and begin distribution of the new Propaq® MD
Monitor/Defibrillator that was developed specifically to meet the
special needs of military customers and air medical operations
worldwide. Development of this product was a joint undertaking between
the Department of Defense and a cooperative arrangement between Welch
Allyn and ZOLL. Development was facilitated with grants from the U.S.
Army Medical Research and Development Command.
The Propaq MD is a new ultra-lightweight compact device with highly
sophisticated, advanced capabilities that combine the well-accepted and
proven features of the Propaq monitors with the clinically superior
therapeutic capabilities of ZOLL defibrillation and non-invasive pacing
technologies. The Propaq MD is 60 percent smaller and 40 percent lighter
than other similar monitor/defibrillators. It is two pounds lighter than
the current military vital signs monitor, the Propaq 206, even with
defibrillation and pacing added.
The Propaq MD provides an unmatched combination of capabilities that
include a large, high-contrast color LCD display capable of viewing up
to four waveforms simultaneously, as well as a full 12-lead ECG for
on-screen review. It also offers a unique night vision goggle (NVG) mode
for military and air medical night time operation. All physiological
monitoring parameter values, including heart rate, SpO2, ETCO2,
respiration, non-invasive blood pressure, two temperatures, and three
invasive pressures, are shown in large color-coded numeric formats. The
device is capable of monitoring all patients, whether adult, pediatric
or neonatal. Alarms are provided for all parameters. The Propaq MD is
the only FDA-cleared airworthy defibrillator to provide monitoring of
three invasive pressures necessary for treating critical patients during
long transports.
A new battery system and AC power charger provides worldwide land, sea
and air operating capability. The system can monitor all physiological
parameters, including three invasive pressures and two temperature
channels, for over six hours on a single battery charge.
In addition to real-time monitoring, the Propaq MD has a full data
collection and trending capability. Keys are provided to annotate all
ACLS interventions such as intubation, drug administration, and
associated ECG and other physiological waveform segments. Full trending
data is available on the unit's display from its integral memory,
supporting data collection over 24-hour periods. Trends can include
1,000 time-stamped events and 32 snapshots of treatment. All data can be
downloaded to a standard USB flash drive and transferred to electronic
medical records using an open architecture XML format. An integrated
printer can provide immediate documentation of events and diagnostic ECG
traces.
?The approval of this product marks a milestone for ZOLL in terms of
expansion of business opportunities with military organizations around
the world,? said Jonathan A. Rennert, President of ZOLL. ?Between the
success of the earlier Welch Allyn Propaq monitors and ZOLL M Series®
CCT (Critical Care Transport) monitors/defibrillators in military
applications over the last decade, the number of devices subject to
upgrade and replacement in the next few years will drive substantial
business in this segment. We believe we are well-positioned to capture a
significant share.?
Designed specifically for the tough demands of battlefield medicine,
encompassing air transport and evacuation, and highly mobile ground, sea
and air deployments of medical assets, the Propaq MD meets an
unprecedented number of military and international standards related to
durability, environmental operation and storage extremes, radio
frequency emissions, and susceptibility to spurious electrical and radio
frequency noise. The Propaq MD is also rated at the most stringent IP55
rating for dust and water ingress.
In addition to the Propaq MD, a companion Propaq M model, which will be
a monitor only version of Propaq MD, has been developed to have, a
completely identical and common interface for operation, batteries,
power supplies, blood pressure cuffs, accessories, data and cables, but
without therapeutic defibrillation and pacing capability. The Propaq M
has not been reviewed and cleared by the FDA. These two products, when
combined, will meet the most expansive needs of the military for patient
care in austere environments. In addition to the common interfaces
between the two units, virtually all existing Propaq monitor
accessories, cables connectors, and ZOLL M Series CCT defibrillation
accessories currently used in military applications will be forward
compatible with the new products.
About ZOLL Medical Corporation
ZOLL Medical Corporation develops and markets medical devices and
software solutions that help advance emergency care and save lives,
while increasing clinical and operational efficiencies. With products
for defibrillation and monitoring, circulation and CPR feedback, data
management, fluid resuscitation, and therapeutic temperature management,
ZOLL provides a comprehensive set of technologies which help clinicians,
EMS and fire professionals, and lay rescuers treat victims needing
resuscitation and critical care.
A NASDAQ Global Select company and a Forbes 100 Most Trustworthy Company
in 2007, 2008, and 2009, ZOLL develops and manufactures its products in
the United States, in California, Colorado, Illinois, Massachusetts,
Pennsylvania, and Rhode Island. More than 400 direct sales and service
representatives, 1,100 business partners, and 200 independent
representatives serve our customers in over 140 countries around the
globe. For more information, visit www.zoll.com.
Certain statements contained in this press release, including
statements regarding the future business of the Company, and other
statements contained herein regarding matters that are not historical
facts, are ?forward-looking? statements (as defined in the Private
Securities Litigation Reform Act of 1995). Because such statements are
subject to risks and uncertainties, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Factors that could cause actual results to differ materially from those
expressed or implied by such forward-looking statements include, but are
not limited to, those factors discussed in the section entitled ?Risk
Factors? in the Company's Quarterly Report on Form 10-Q
filed with the SEC on May 14, 2010. You should not place undue reliance
on the forward looking statements in this press release, and the Company
disavows any obligation to update or supplement those statements in the
event of any changes in the facts, circumstances, or expectations that
underlie those statements.
Copyright © 2010 ZOLL Medical Corporation. All rights reserved. 269 Mill
Road, Chelmsford, MA 01824-4105. ZOLL and M Series are trademarks and/or
registered trademarks of ZOLL Medical Corporation. All product names are
the property of their respective owners.
INVESTOR CONTACT:
ZOLL Medical Corporation
A. Ernest
Whiton, +1-978-421-9655
Chief Financial Officer
or
MEDIA
CONTACT:
ZOLL Medical Corporation
Diane Egan,
+1-978-421-9637
degan@zoll.com
