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Publication of clinical study

4th Jan 2007 07:00

Deltex Medical Group PLC04 January 2007 Deltex Medical Group plc New study demonstrates fundamental technological advantages of CardioQ(TM) 4 January 2007 Deltex Medical Group plc ('Deltex Medical' or the 'Company'), theUK's leading haemodynamic monitoring company, today announces the publication bya leading scientific journal of a clinical study comparing multiple, alternativehaemodynamic monitoring technologies to the CardioQ in patients undergoingsurgery. Dr Bundgaard-Neilsen and colleagues at University Hospital, Copenhagen carriedout the study as part of Professor Henrik Kehlet's 'fast-track' surgery researchprogramme. The aim of the study was to determine whether a fluid managementprotocol using the CardioQ, the only haemodynamic monitor proven to improveoutcomes in multiple clinical trials, could be replicated using alternativetechnologies. During the study, patients were given fluid, guided by the CardioQ, using astandard protocol. Changes in the parameters measured by a variety of monitoringtechnologies were recorded simultaneously and compared to changes seen with theCardioQ. The results of the study showed that there were no significant changes in bloodpressure during fluid delivery. There were also no significant changes inblood-oxygen levels during fluid delivery when these were measured in muscle orthe brain and, although centrally measured blood-oxygen levels did increaseduring fluid delivery, these could not be used as a guide to optimisation whencompared to the CardioQ. Heart rate decreased as patients were optimised, aswould be expected from earlier clinical studies, but this is of little value influid management. The pressure-based cardiac output monitoring technology usedin the study was either unable to detect the magnitude of change seen by theCardioQ or unable to detect those changes as quickly as the CardioQ. The study is published in the January edition of the British Journal ofAnaesthesia. The abstract of the paper is available online at http://bja.oxfordjournals.org/cgi/content/abstract/98/1/38 where the full paper is also available to subscribers. Deltex Medical's chief executive, Andy Hill, commented: "In over 80% of patients in this study the chosen pressure-based cardiac outputmonitoring system either suggested that the patient was 'optimised' when theCardioQ clearly showed a requirement for significantly more fluid or vice versa.Based on these results it would be impossible to use this kind of system tofollow the intra-operative fluid delivery protocol that has been repeatedlydemonstrated in studies with the CardioQ to reduce complications and shortenlength of stay. In the absence of clinical evidence supporting any alternative approaches, theCardioQ clearly must be considered the de facto standard of care for fluidmanagement in patients having surgery." For further information, please contact:- Deltex Medical Group plc 01243 774 837Nigel Keen, Chairman [email protected] Hill, Chief Executive [email protected] Phillips, Finance Director [email protected] Gavin Anderson & Company 0207 554 1400Marie Cairney [email protected] Reilly [email protected] Charles Stanley Securities 020 7149 6457Philip Davies [email protected] Notes for Editors Deltex Medical manufactures and markets the CardioQ monitor, which usesdisposable ultra-sound probes inserted into the oesophagus to determine theamount of blood being pumped around the body - 'circulating blood volume'.Reduced circulating blood volume is known as hypovolaemia, which leads toinsufficient oxygen being delivered to the organs. This causes medicalcomplications including peripheral and major organ failure which can lead todeath. Hypovolaemia, which is akin to severe dehydration, affects virtuallyevery patient having surgery because of the combined effects of pre-operativestarvation, the impact of the anaesthetic agents and trauma from the surgeryitself. Using fluids and drugs, guided by the CardioQ, to optimise the amount ofcirculating blood significantly reduces post-operative complications allowingpatients to make a faster, more complete recovery and return home earlier. The CardioQ incorporates the Company's proprietary software and a smalldiameter, easy-to-use, minimally invasive, disposable oesophageal probe that isused for transmitting and receiving an ultra-sound signal. By using thistechnology, the CardioQ provides clinicians with the ability to haemodynamicallyoptimise critically ill patients and those undergoing routine moderate to majorsurgery through the controlled administration of fluid and drugs. Haemodynamicoptimisation has been scientifically proven to improve the speed and quality ofpatient recovery and reduce hospital stay. There are already over 1,250 CardioQs currently in use in hospitals worldwideand distribution arrangements are in place in over 30 countries. In addition,there are currently more than 90 clinical publications on the use of the CardioQwhich have repeatedly:- •Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works •Proved that the CardioQ works in a wide range of surgical procedures •Demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients. This information is provided by RNS The company news service from the London Stock Exchange

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