Deltex Medical Regulatory News (DEMG)

4 May 2005 07:00

Deltex Medical Group PLC04 May 2005 Deltex Medical Group plc CardioQ reduces hospital stay by 2 days in colorectal surgery patients 4 May 2005: Deltex Medical Group plc ("Deltex Medical" and the "Company"),today announces the results of a double-blinded prospective randomisedcontrolled clinical trial using its CardioQ(TM) haemodynamic monitoring system on post-operative colorectal patients. The trial was undertaken by surgeons and anaesthetists at the Freeman Hospitalin Newcastle-upon-Tyne. The first results to come from the study were presentedthis week at the American Society of Colon and Rectal Surgeons meeting inPhiladelphia. In the trial 108 patients undergoing elective colorectal surgerywere divided into two groups of 54 each. The control group were given fluidsperi-operatively at the anaesthetist's discretion whereas the treatment groupwere given fluids based on an algorithm guided by the CardioQ. The statistically significant results of the study presented in Philadelphiaincluded a reduction in major post surgical complications in the CardioQ groupwith only 1% of patients suffering such a complication compared to 13.7% in thecontrol group. The average (median) hospital stay was seven days for CardioQpatients compared to nine days in the control group. Further details areexpected to be given at future clinical meetings and on publication of the fullstudy results. The trial concluded that fluid optimisation using the CardioQleads to shorter hospital stays and a decrease in major morbidity withconsequent major implications for the management of patients in fast-trackregimens. Deltex Medical's Chief Executive, Andy Hill commented: "The results of this study have a number of important implications for theCompany. The study adds to the substantial amount of positive evidencesupporting the use of the CardioQ in moderate and major surgery in general and,following a similar study from Worthing Hospital announced last September, incolorectal surgery as a stand-alone speciality. This allows us to market thebenefits of the CardioQ in the treatment of bowel cancer as well as inperi-operative anaesthesia. "As the study was the first one using the CardioQ to be led by surgeons ratherthan anaesthetists, its findings should reach a wider audience than previousstudies at a time when colorectal surgeons are being increasingly scrutinisedwith regard both to the quality of outcome for their patients and the total costof the patient's surgery and hospital stay." For further information, please contact:- Deltex Medical Group plc 01243 774 837Nigel Keen, ChairmanAndy Hill, Chief ExecutiveEwan Phillips, Finance Director Financial Dynamics 0207 831 3113David YatesLucy Briggs 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 amountof circulating 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