A. Ernest Whiton
Chief Financial Officer
ZOLL Medical Corporation
+1 (978) 421-9655
ZOLL Medical Corporation
+1 (978) 421-9637
ZOLL PROPAQ M MONITOR GRANTED 510(K) CLEARANCE BY U.S. FOOD AND DRUG ADMINISTRATION
Propaq M and Propaq MD, First System Designed with Interchangeability, Flexibility and Portability for Military and Air Medical Operations
September 21, 2010─CHELMSFORD, MASS.–ZOLL Medical Corporation (Nasdaq GS: 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® M Monitor, a vital signs monitor for deployable military medicine that was developed 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 M is a new ultra-lightweight, compact device that combines highly sophisticated, advanced capabilities with the well-accepted and proven features of the Propaq monitors. New features of the Propaq M include 12-lead monitoring, a third invasive pressure channel, extensive trending and data collection, a large high-contrast color display with 4-waveform capability, a night vision goggle (NVG) mode for military and air medical night operations, and a user-removeable battery that will operate all the physiological parameters for over 7.5 hours. These new capabilities were designed into a new small, lightweight, rugged package nearly 5 lbs. lighter than currently deployed technology.
The Propaq M is a companion monitor version of the recently FDA-cleared Propaq MD transport monitor/defibrillator and has been developed to have a completely identical and common interface for operation, batteries, power supplies, blood pressure cuffs, cables, accessories, and data. This common interface between the Propaq M and Propaq MD facilitates a seamless transition and operator readiness. The Propaq M is the first transport monitor to utilize the same user interface and components as the Propaq MD, thus allowing military and air medical services to save significant expenses in training and logistics. These new products comprise the first system designed with a combination of interchangeability, flexibility, and portability to meet the special needs of critical care monitoring and therapy for the military.
“These two products, when combined, will meet the most expansive needs of the military for patient care in difficult environments,” said Jonathan A. Rennert, President of ZOLL. “The FDA clearance of both devices is a significant milestone for ZOLL. Given the success of earlier
Welch Allyn Propaq monitors and ZOLL M Series® CCT (Critical Care Transport) monitor/defibrillators, we are well-positioned to capture a significant share of the military market as the need to replace and upgrade devices creates substantial business opportunities.”
In addition to the common interfaces between the Propaq M and Propaq MD, virtually all existing Propaq 206 monitor accessories, cables connectors, and ZOLL M Series CCT defibrillation accessories currently used in military applications will be compatible with the new products.
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 M 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 M, like Propaq MD, is rated to the most stringent water and sand/dust protection, achieving a rating of IP55, allowing protection from extremely fine sand and jets of water.
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 that 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 August 11, 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. M Series and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners.