Deltex Medical Regulatory News (DEMG)

4 Oct 2006 07:01

Deltex Medical Group PLC04 October 2006 Deltex Medical Group plc Publication of clinical trial using SupraQ(TM) to compare different approaches to epidural anaesthesia in women undergoing caesarean delivery 4 October 2006 - Deltex Medical Group plc ('Deltex Medical' or the 'Company'), the UK's leading haemodynamic monitoring company, today announces the publication of a randomised, controlled clinical trial comparing two approaches to epidural anaesthesia in women undergoing elective caesarean delivery. The results were published in the medical journal Anesthesia and Analgesia. Doctors at the Royal Free Hospital in London, under the leadership of Dr RoshanFernando, used Deltex Medical's SupraQ monitor to look at haemodynamic stabilityduring epidural anaesthesia. The SupraQ was chosen because it is whollynon-invasive and can provide doctors with information about a patient'shaemodynamic status that previously was only available using invasive monitoringtechnology. These more invasive systems were felt to pose too great a risk ofcomplications to be appropriate for use in these healthy patients. Traditionalmeasures of haemodynamic status like blood pressure and heart rate areinsufficiently sensitive to detect changes in haemodynamic status early enoughto be of value. This trial is the first to compare the changes in haemodynamic status caused bythese two methods of delivering epidural anaesthesia. The aim of the trial was to test the impact of the different approaches toanaesthetic delivery on haemodynamic stability in order to better inform medicalresearch and the development of improved anaesthetic protocols for patientsundergoing caesarean delivery. Dr Fernando commented: "The results of this trial will prove invaluable in improving the management ofhigh-risk patients presenting for caesarean section, such as those withsignificant cardiovascular disease." Deltex Medical's chief executive, Andy Hill, commented: "This trial confirms the need and potential for a wholly non-invasivehaemodynamic monitor that can provide doctors with the same reliable,high-quality data, in real-time, as the CardioQ. The SupraQ allowed Dr Fernandoand his collaborators to measure changes in key indicators of cardiac functionas they happened, something that more invasive and potentially riskyalternatives cannot do." For further information, please contact: Deltex Medical Group plc 01243 774 837Nigel Keen, Nigel ChairmanAndy Hill, Chief ExecutiveEwan Phillips, Finance Director Gavin Anderson & Company 020 7554 1400Deborah WalterMarie CairneyJodie Reilly Charles Stanley Securities 020 7149 6457Philip Davies 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