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PRESS RELEASE - 12 APRIL 2010
TGA APPROVAL AND CE MARK GRANTED - NAVIGATOR™ IS APPROVED FOR SALE IN AUSTRALIA AND EUROPE
Navigator™, the breakthrough cardiovascular care system from Applied Physiology, has received TGA certification and CE marking and is now approved for sale in Australia and Europe. This new device, with its unique graphical display will be available throughout these territories from second quarter, 2010.
Applied Physiology CEO, Philip Daffas, said ”We are delighted to receive these approvals, especially on the back of a very successful ISICEM conference in Brussels. Navigator™ was one of the stand-out products at the conference - we sense the customers and market conditions are ready to adopt the Navigator™ Cardiovascular Clinical Decision Support technology. Navigator™ has been the subject of great commercial and academic interest since the clinical trial phase. This interest intensified at the Brussels ISICEM two weeks ago, after several well-received lectures on the benefits of Guytonian approach to cardiovascular management – the approach implemented by the Navigator™ device.
The talks explaining this approach and its benefits had an obvious impact on the audience throughout the conference, culminating in the “Applied Physiology by the Bedside” satellite symposium.
Dr Michael Pinsky summed up the benefits, emphasizing that this is a new way of looking at patient treatment, but that it is by no means a new, untried theory; clinicians simply need to apply their existing knowledge in order to use Navigator™ and reap the benefits of this physiology-based approach, “We're looking with fresh eyes at disease and it's treatment. This is a new way of considering what we're doing. We're actually able to look for the first time at our patients in the operating room and in the ICU and see cardiac performance, and effective circulating blood volume. Navigator enables you to take your understanding of cardiovascular physiology, what you learned in medical school, and apply it at the bedside. Using Navigator, you have the data in your hand to make that decision”.
Navigator™ is a clinical decision support system designed for use in critical care units. It calculates the patient’s volume, cardioactive and resistive states and uses this information to draw a graph displaying the patient’s current status against pressure and flow targets set by the clinician. Its unique graphical display helps clinicians to anticipate the probably effects of therapy, and to observe the effects of therapies as they are administered.
Regulatory applications have also been lodged with the FDA. Applied Physiology plans to release Navigator™ into the US market after the commercial launch in Europe and Australia.
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