SIGNAL HILL, Calif., Oct. 13 /PRNewswire/ -- Integrated Medical Systems, Inc., a medical technology systems integrator developing fully integrated products for critical care, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its MedEx 1000(TM) "suitcase" intensive care unit (ICU).
"FDA clearance of the MedEx 1000 is a major accomplishment for the company as we continue to demonstrate the economic and clinical value of integrated patient care technologies," said Todd Kneale, President and Chief Operations Officer of Integrated Medical Systems, Inc. "This clearance is significant because it was received in less than 60 days from submittal of the application, includes the company's new modular integrated architecture that will serve as a basis for an entire product family of scalable, customizable integrated solutions, and includes the first centralized control - as well as the first remote control - of multiple medical, data and utility capabilities. Just like systems integration transformed the automotive, aerospace and computer industries, the company is at the forefront of transforming healthcare through systems integration."
"We believe this innovative system addresses a large unmet clinical need to support continuous patient care," said Adam Seiver, MD, PhD, Adjunct Clinical Associate Professor of Surgery Medical School, Stanford, former Director of Surgical Critical Care at Stanford Medical Center, and a member of company's Board of Advisors. "The MedEx 1000 is the first hand-portable integrated medical, data and utility suite. Caregivers will now be able to provide continuous care, never needing to disconnect and re-connect a patient from therapy and monitoring as the patient is moved throughout a hospital, or even pre-hospital transport or disaster response. This technology meets a key need to increase patient and caregiver safety, while at the same time reducing the weight, volume, cost and clutter of current equipment.
Initial deliveries of the MedEx 1000 are expected in the first quarter of 2009. IMS expects to have a CE Mark by fall 2008, permitting marketing and sales in Europe.
About the MedEx 1000
The MedEx 1000 is a portable unit intended to supply ICU functionality for adult and pediatric patients. The MedEx 1000 combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities and the ability to deliver oxygen to a patient. The functions of the MedEx 1000 are controlled from a central user interface. The MedEx 1000 may be operated using either hot-swappable battery power or an external source. The unit can accept external high pressure or low pressure sources of oxygen. A USB Port provides connectivity to an external printer, and allows for a connection of a USB flash drive to off-load (download) logged data. An Ethernet Port allows for Local Area Network (LAN) connectivity. The MedEx 1000 is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities. A future upgrade will allow additional medical devices to be added using the Auxiliary Device Port and be controlled and displayed through the MedEx 1000.
The purpose of the MedEx 1000 is to help support continuous patient care during transport from outside of the hospital or within the hospital environment. Current practice includes frequently disconnecting and reconnecting a patient from therapy and monitoring when a patient is transported. During transport, caregivers have to juggle multiple medical devices and when they arrive at a destination, connect the devices to a central computer. Use of the MedEx 1000 not only increases patient safety, but caregiver efficiency, as well. Clinical studies with the predicate device, the LSTAT(TM) stretcher-based integrated patient care platform, demonstrated the need for fewer caregivers during transport, faster response time to adverse events, faster 'time to go' between wards, and potential reduction in the hospital length-of-stay ("Life Support for Trauma and Transport: a mobile ICU for safe in-hospital transport of critically injured patients", Velmahos et al, Journal of the American College of Surgeons, 2004 July;199 (1):62-8).
About Integrated Medical Systems
Integrated Medical Systems, Inc. (IMS) is the leading innovator in the development of fully integrated products for critical care. Our firm, whose principal shareholders include Northrop Grumman Corporation (NGC), is committed to the rapid deployment of products that include portable intensive care systems, advanced diagnostic and therapeutic devices, telemedicine networks, and related information systems. For more information on IMS and the MedEx 1000 "suitcase ICU", please visit http://www.medex1000.com
|SOURCE Integrated Medical Systems, Inc.|
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