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December 5, 2006 December 12th – December 18th December 12th: Draeger Medical, Inc. Launches New Emergency and Transport Ventilation System Draeger Medical, Inc. announces the launch of its newest ventilation system, the Oxylog 3000, into the U.S. market. Designed for the demanding emergency and transport environments, the Oxylog 3000 is ideal for supporting critical-care patients in transfer situations. With its combination of volume and pressure-controlled and pressure support ventilation across the entire breathing cycle, the Oxylog 3000 delivers the high-end performance sought by today's caregivers. Oxylog 3000 provides the flexibility of both comprehensive invasive or non-invasive ventilation support, including the ability to provide automatic back-up support for spontaneously breathing patients in the event of apneas. In addition, the Oxylog 3000 features integrated PEEP, and 100% oxygen flush - providing three minutes of pre-oxygenation and inspiration hold, for use during X-ray imaging. The Oxylog 3000's tidal volume begins at just 50ml so it can be used for small children and adults alike. And its patented blender permits oxygen concentration adjustments between 40 percent and 100 percent with greater precision and range than previously possible. Designed and manufactured with the same attention to detail and performance as Draeger's high-end Evita ICU ventilators, the Oxylog 3000 represents a significant advance in emergency and transport ventilation systems. "From its large, high contrast display screen to its fast and easy control system, the Oxylog 3000 is built to support the needs of respiratory care professionals in a wide range of situations," noted Tim Scharn, marketing manager for Pre- and Post-Hospital Care at Draeger Medical, Inc. "We've greatly expanded the Oxylog's capabilities so that patients and caregivers benefit from its improved functionality, greater flexibility and reliability." Featuring an entirely new design, the Oxylog 3000 is light, compact and easy to carry and use. It features a combination of the well-known Oxylog "knobs," for quickly setting the most vital parameters, and Draeger's familiar centralized rotary wheel for setting individual parameters. In addition, its robust, spray-proof construction and suitability for use in helicopters mean that the Oxylog 3000 can stand up to aggressive use in even the most extreme environments. December 13th: Ortho-Clinical Diagnostics Receives FDA Approval for First Blood-Screening Test for Chagas ‘disease Ortho-Clinical Diagnostics, a Johnson & Johnson company, announced today that the U.S. Food and Drug Administration (FDA) has licensed its new test designed to screen blood donations for exposure to Chagas' disease -- a tropical, parasitic disease that originates in South America. Called the ORTHO® T.cruzi ELISA Test System, it is the first blood-screening test for Chagas' disease approved by the FDA for use in the United States. A study conducted in the same geographic area of the U.S. documents ratios of Chagas- seropositive blood donors ranging from one positive in 9,900 in 1996, to one in 7,200 in 1997, to one in 5,400 in 1998. (1) A new study, just completed in November of this year, documents the ratio of Chagas-seropositive blood donors at approximately one in 2, 000. (2) In clinical trials, the ORTHO® T.cruzi ELISA Test System demonstrated 100 percent sensitivity to all geographic strains tested of Chagas' disease, and demonstrated an observed specificity of 99.99 percent. The test qualitatively detects T.cruzi antibody in human serum and plasma. The test, fully automated on the Ortho Summit(TM) System, will be used to screen blood donations for the presence of antibodies that develop in response to exposure to the parasite that can cause Chagas' disease. Ortho-Clinical Diagnostics will immediately launch the ORTHO® T.cruzi ELISA Test System and has sufficient production capacity to meet the needs of blood banks nationwide. In 2007, Ortho-Clinical Diagnostics will seek FDA approval to expand use of its test for Chagas' disease in tissue and cell transplants (cadaveric testing) and for general diagnostic purposes. December 18th: FDA Approves Next-Generation Possis AngioJet(R) System Possis Medical, Inc. (NASDAQ:POSS ) a developer, manufacturer and marketer of pioneering medical devices for the cardiovascular and vascular treatment markets, today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for its new AngioJet® Ultra Thrombectomy System. Ultra is the next-generation, completely re-engineered version of Possis' proven, industry leading AngioJet Rheolytic(TM) Thrombectomy System. AngioJet is marketed for blood clot removal (thrombectomy) from arterial and venous blood vessels. The new Ultra System features a simple and fast setup process, the flexibility to use a broad range of catheters, a sleeker design, lighter weight, and handling improvements that make it significantly easier to maneuver than the previous AngioJet drive unit. "This is an exciting time for Possis and our customers," said Robert G. Dutcher, chairman, president and CEO. "Since its debut in 1997, the AngioJet System has become the medical industry's leading thombectomy system and has successfully treated 300,000 patients worldwide. The Ultra System, which is easier to use and offers much broader catheter flexibility, marks the next step in Possis' evolution, and provides the long-term growth platform for our AngioJet business." Simple setup process--Versus Possis' original AngioJet drive unit that requires 20 steps in the setup process, Ultra's advanced microprocessor design automatically performs most of the setup steps by reading a bar code located on each disposable thrombectomy set. The few remaining steps are intuitive and require minimal user training. Flexibility to use a broad range of catheters--The Ultra System provides the ability to use a wide range of catheters, both existing as well as those in development, and the system's flexibility promotes the design of new catheters. Sleeker design and lighter weight--With its updated design, Ultra is 46 percent lighter than the previous AngioJet drive unit and its compact, ergonomic design make it significantly easier to move around the hospital. According to Possis, Ultra features an advanced control system with easier, more intuitive commands. Ultra also allows the physician to easily switch to Possis' patented Power Pulse(TM) delivery when necessary, simultaneously delivering clot-dissolving drugs while removing blockages from the affected arteries and veins. Possis will conduct market evaluations of the Ultra System at key sites throughout the United States. A full-market release is anticipated by Summer 2007.
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