28th Mar 2007 08:00
Deltex Medical Group PLC28 March 2007 Deltex Medical Group plc US Government funded review of the CardioQTM 28 March 2007 Deltex Medical Group plc ('Deltex Medical' or the 'Company'), theUK's leading haemodynamic monitoring company, has completed its preliminaryreview of the US Government funded Health Technology Assessment (HTA) of theclinical evidence supporting the use of oesophageal Doppler monitoring. Background The HTA, dated 16 January 2007, was commissioned by the Centers for Medicare &Medicaid Services (CMS), the government body responsible for determiningcoverage for the reimbursement of medical technologies in the USA. The reportwas published by CMS on 14 March 2007 and is available on www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=45. The HTA process grades evidence whether a technology does or does not work intofour categories: 'strong', 'moderate', 'weak' and 'inconclusive'. Strongevidence is defined as 'Evidence supporting the qualitative conclusion isconvincing. It is highly unlikely that new evidence will lead to a change inthis conclusion'. Key conclusions The HTA concluded that in 'patients undergoing surgical procedures with anexpected substantial blood loss or fluid compartment shifts requiring fluidreplacement' the clinical evidence for ODM was strong in respect of thefollowing three statements: 1. 'Doppler-guided fluid replacement during surgery leads to a clinicallysignificant reduction in major complications'; 2. 'Doppler-guided fluid replacement during surgery leads to a clinicallysignificant reduction in the total number of complications'; and 3. 'Doppler-monitored fluid replacement leads to a reduction in hospitalstay'. The HTA did not reach any conclusions about the use of ODM in intensive care asit considered only one published outcome trial, albeit a good quality positivestudy (McKendry et al: BMJ 2004 July 31;329(7460):258). Other conclusions 1. Quantitative conclusions The HTA methodology applied did not allow the authors to draw any quantitativeconclusions, such as the degree of reduction in major complications or thenumber of days reduction in length of stay. The Company expects that alternativemethodological approaches in other appraisals of ODM will reach conclusions onthese quantitative areas. 2. Pulmonary artery catheter (PAC) PACs, which use the technique of thermodilution to estimate cardiac output, havebeen regarded as a standard of care for cardiac output monitoring for over 30years and are used in between one and a quarter and two million patients eachyear in the USA. Deltex Medical has never manufactured or sold PACs: the CardioQwas originally developed as a minimally invasive alternative to PACs. In thesection on alternative technologies, the HTA notes with respect to PACs: 'Thermodilution is not a true "gold standard" technique. Under idealcircumstances, the fluid bolus method has a 10% error rate related to instrumentinaccuracies, operator error and temperature transduction. The relative accuracyof the continuous method is uncertain. Furthermore, the invasiveness of thesemethods carries a risk of serious complications'. AHRQ's website notes that it is currently undertaking a technology assessment onPACs. To date, the only technology assessment on PAC of which the Company isaware, was funded by the UK Government, looked at use of the PAC in intensivecare units and was published in September 2006 (Harvey S et al; HealthTechnology Assessment 2006; Vol. 10: No. 29): it suggested that 'withdrawing thePAC from routine use in the NHS is likely to produce health gains'. 3. Safety The HTA concludes that 'the available evidence suggests that oesophageal Dopplerprobes are relatively low-risk devices, as reporting of even minor morbidity hasbeen infrequent thus far.' Deltex Medical's chief executive, Andy Hill, commented: "The AHRQ Health Technology Assessment gives a resounding independentendorsement of the CardioQ and its proven ability to reduce major complicationsafter surgery and the time patients have to spend in hospital after surgery. "In the modern era of evidence based medicine, health technology assessments areof increasing importance. In the USA, this report underpins the CMS's proposalto cover the CardioQ for reimbursement for use both during surgery and inintensive care. Outside the USA, we expect that the report will help toaccelerate adoption of the CardioQ as a standard of care." 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 1400Deborah Walter [email protected] Speed [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. 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 ExchangeRelated Shares:
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