ZOLL Propaq MD Monitor/Defibrillator Granted 510(k) Clearance by U.S. Food and Drug Administration

Published on Friday, 30 July 2010 08:08 Written by TradersHuddle Staff

CHELMSFORD, Mass.-( Business Wire )-

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 CorporationA. Ernest Whiton, +1-978-421-9655Chief Financial OfficerorMEDIA CONTACT:ZOLL Medical CorporationDiane Egan, + This e-mail address is being protected from spambots. You need JavaScript enabled to view it.