Deltex Medical Regulatory News (DEMG)

14 Apr 2008 07:01

Deltex Medical Group PLC14 April 2008 Deltex Medical Group plc Largest audit of the CardioQ(TM) in "fast-track" bowel surgery set to expand 14 April 2008 - Deltex Medical Group plc ("Deltex Medical"), the UK's leadinghaemodynamic monitoring company, today announces that doctors in Spainundertaking the largest ever audit of the impact of the Company's CardioQoesophageal Doppler monitor (ODM) are expanding the number of hospitals involvedin the project. Dr Jose Manuel Ramirez, one of Spain's most senior surgeons and a specialist inbowel surgery at the University Hospital in Zaragoza, is leading the audit whichwill examine changes in the numbers of complications and lengths of stay inpatients undergoing major bowel surgery using the CardioQ in a "fast-track"surgery setting compared to historical data for patients undergoing similarsurgery using traditional approaches to care. "Fast-track" or "enhanced recovery" protocols combine elements of best practicein surgical techniques and patient care to keep patients as well as possibleimmediately before, during and after their surgery. Originally planned to be conducted across seven hospitals in Spain, interest inthis independent project, organised and supervised by the University of Zaragozahas been such that Dr Ramirez felt it appropriate to expand this to include afurther four hospitals, although many more expressed strong interest in beinginvolved. Deltex Medical has been working closely with Dr Ramirez and his colleagues andtraining at the first group of hospitals is now complete. The new sites will betrained over the coming weeks. Data collection will begin on 1 May 2008 and isexpected to conclude at the end of October, in time for presentation of theresults at the Spanish National Congress of Surgery in Madrid in November 2008. Dr Ramirez commented: "Surgeons have added strategies during surgery designed to enhance patients'recovery still further. They use minimally invasive surgical techniques andepidural anaesthesia wherever possible and precise cardiac and fluid monitoringduring operations through an oesophageal Doppler probe used with CardioQ, whichmonitors blood flow from the heart. In elective complex surgical proceduresthese approaches have been shown in trials to lead to a lower rate ofpostoperative complications and shorten time to recovery and hospital stay, ourobjective is to promote and press forward with these programmes in the field ofgeneral and digestive surgery" The Spanish Agencia Lain Entralgo para la Formacion, Investigacion y EstudiosSanitarios de la Comunidad de Madrid, Spain's equivalent to the UK's NationalInstitute for Health and Clinical Excellence (NICE), is closely involved in theaudit project and its remit includes making recommendations on a national basisabout which new technologies should become integrated as routine practice in theSpanish health service. Mr. Juan Antonio Blasco Amaro, who is responsible for medical device evaluationat the Agencia Lain Entralgo para la Formacion, Investigacion y EstudiosSanitarios de la Comunidad de Madrid commented: "The outcome of this study could make the CardioQ a specification and preferabledevice of use included in the social security health program" Deltex Medical's Chief Executive, Andy Hill commented: "Fast-track and enhanced recovery programmes are gaining ground as the standardof care for patients having bowel and other major surgical procedures. DrRamirez's project has the very real potential to accelerate substantially theadoption of this approach across more than 200 hospitals in Spain performingthis kind of surgery." For further information, please contact:- Deltex Medical Group plc 01243 774 837Nigel Keen, Chairman njk@deltexmedical.comAndy Hill, Chief Executive ahill@deltexmedical.comEwan Phillips, Finance Director eap@deltexmedical.com Gavin Anderson & Company 0207 554 1400Deborah Walter dwalter@gavinanderson.co.ukRobert Speed rspeed@gavinanderson.co.ukStuart Macaulay smacaulay@gavinanderson.co.uk Charles Stanley SecuritiesNominated Advisors 020 7149 6000Philip Davies philip.davies@csysecurities.comRussell Cook russell.cook@csysecurities.com 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 optimisecritically ill patients and those undergoing routine moderate to major surgerythrough the controlled administration of fluid and drugs. Haemodynamicoptimisation has been proven to improve the speed and quality of patientrecovery and reduce hospital stay. There are already around 1,500 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. The SupraQ is an entirely non-invasive device which uses an ultrasound probeheld at the base of the patient's neck to track the flow of blood in the aorta;it presents the same data as the CardioQ in a similar format and is used fortaking snapshots or monitoring over short periods. This information is provided by RNS The company news service from the London Stock Exchange