US HTA on pulmonary artery ca

RNS Number : 3922D

Deltex Medical Group PLC

15 September 2008

 



Deltex Medical Group plc

US health technology assessment finds no benefit from pulmonary artery catheters

15 September 2008 - Deltex Medical Group plc ('Deltex Medical' or the 'Company'), the UK's leading haemodynamic monitoring company and global leader in oesophageal Doppler monitoring ('ODM'), notes the publication in the USA of a health technology assessment evaluating the evidence in the benefits and harms of pulmonary artery catheter (PAC) use in critical care settings including major surgery.

The report was prepared by the Tufts Medical Center Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ) and commissioned by the Centers for Medicare & Medicaid Services (CMS), the taxpayer funded part of the US healthcare system. Although dated 28 March 2008, the report has only recently been made generally available at:

www1.cms.hhs.gov/mcd/viewtechassess.asp?from2=viewtechassess.asp&where=index&tid=55&

The report addresses primarily the use of PAC in the CMS population of US patients over the age of 65 and concludes that:

'The available evidence does not consider many special circumstances where there may be reason to suppose that PAC is of value. However, the evidence does support the conclusion that in patients for whom PAC use is not deemed absolutely necessary, the routine use of PAC does not improve long-term clinical outcomes. At the same time, PAC use imposes uncommon, but identifiable, risks of adverse events. Physicians should be educated about the risks and benefits of PAC-directed therapy to allow for judicious decisions about its use on an individual basis.'

Deltex Medical's Chief Executive, Andy Hill commented:

'Unlike in the UK, where use of PAC has fallen dramatically in the last few years, accounting for some part of the CardioQ-ODM's considerable growth, PAC use in the USA remains very high, with most estimates suggesting between one and two million uses a year. Although not yet clear how they might react to this report, it is hard to see how the bodies which pay for healthcare in the USA will wish to continue to spend hundreds of millions of dollars a year to support a technology which appears ineffective at best.

'This represents a tremendous market opportunity for Deltex. All clinical trials on ODM have shown benefit. ODM has never caused a patient an adverse event and, as previously announced, ODM was the subject of a highly positive health technology assessment in 2007 which was also commissioned by CMS. The number of patients for whom CMS deemed ODM both reasonable and necessary is estimated to be at least two or three times higher than even the highest estimate of US PAC use.

For further information, please contact:-

Deltex Medical Group plc            01243 774 837

Nigel Keen, Chairman                    [e-mail]

Andy Hill, Chief Executive              [e-mail]

Ewan Phillips, Finance Director      [e-mail] 

Gavin Anderson & Company       0207 554 1400

Deborah Walter                            [e-mail]

Robert Speed                               [e-mail]

Stuart Macaulay                           [e-mail]

Nominated Adviser & Broker

Charles Stanley Securities         020 7149 6000

Philip Davies                                [e-mail] 

Russell Cook                               [e-mail] 

  Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODM™ monitor, which uses disposable ultra-sound probes inserted into the oesophagus to determine the amount of blood being pumped around the body - 'circulating blood volume'. Reduced circulating blood volume is known as hypovolaemia, which leads to insufficient oxygen being delivered to the organs. This causes medical complications including peripheral and major organ failure which can lead to death. Hypovolaemia, which is akin to severe dehydration, affects virtually every patient having surgery because of the combined effects of pre-operative starvation, the impact of the anaesthetic agents and trauma from the surgery itself. Using fluids and drugs, guided by the CardioQ-ODM, to optimise the amount of circulating blood significantly reduces post-operative complications allowing patients to make a faster, more complete recovery and return home earlier.

The CardioQ-ODM incorporates the Company's proprietary software and a small diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is used for transmitting and receiving an ultra-sound signal. By using this technology, the CardioQ-ODM provides clinicians with the ability to haemodynamically optimise critically ill patients and those undergoing routine moderate to major surgery through the controlled administration of fluid and drugs. Haemodynamic optimisation has been scientifically proven to improve the speed and quality of patient recovery and reduce hospital stay.

There are already over 1,500 CardioQ-ODMs currently in use in hospitals worldwide and distribution arrangements are in place in over 30 countries. In addition, there are currently more than 100 clinical publications on the use of the CardioQ-ODM which have repeatedly:-

• Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works

• Proved that the CardioQ-ODM 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 probe held 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-ODM in a similar format and is used for taking snapshots or monitoring over short periods.

 

END

 

 

NRAILFFEAFIVLIT