NICE

RNS Number : 1858N

Deltex Medical Group PLC

08 June 2010

 



Deltex Medical Group plc

NICE

8 June 2010 - Deltex Medical Group plc ("Deltex Medical" or "Company"), the global leader in oesophageal Doppler monitoring ('ODM'), announces today that the National Institute for Health and Clinical Excellence ('NICE') has selected CardioQ-ODM™ as one of the first products for review by its newly established Medical Technologies Advisory Committee ('MTAC').

MTAC was set up by NICE in November 2009 as part of the NHS response to Lord Darzi's Next Stage Review of the NHS which identified the need to improve the process of identifying, evaluating and adopting effective new medical devices. NICE's Evaluation Pathway Programme for Medical Technologies is intended to help enable new medical technologies to be used more quickly and consistently in the NHS.

NICE's External Assessment Centre has already started the process of reviewing the clinical evidence in respect of the CardioQ-ODM. Clinical evidence submitted to NICE by Deltex Medical includes the health technology assessment on ODM published by the National Institute for Healthcare Research in January 2009 and the How To, Why To guide "Doppler guided intraoperative fluid management" published by the NHS National Technology Adoption Centre in January 2010.

NICE has indicated that draft recommendations are due to be developed by MTAC at its meeting in September 2010 after which there would be a period of public consultation prior to NICE issuing final guidance in 2011.

Ewan Phillips, Deltex Medical's Chief Executive commented:

"We are delighted that NICE selected CardioQ-ODM as one of the very first medical technologies on which to issue Medical Technologies guidance. Their decision to evaluate CardioQ-ODM supports our strategy to drive system-wide adoption of CardioQ-ODM through establishing a robust evidence-base of its clinical and cost-effectiveness.

"NICE is the global leader in making evidence-based recommendations on the clinical and cost effectiveness of medical technologies: a positive NICE recommendation should not only accelerate significantly the adoption of CardioQ-ODM in the UK but also help us create opportunities for accelerated uptake in many of our export markets."

For further information, please contact:-

Deltex Medical Group plc                                01243 774 837

Nigel Keen, Chairman                                         [e-mail]

Ewan Phillips, Chief Executive                            [e-mail]

Paul Mitchell, Finance Director                            [e-mail]

Nominated Adviser & Broker

Arden Partners plc                                           020 7614 5900

Chris Hardie                                                      [e-mail]

Matthew Armitt                                                  [e-mail]

Kreab Gavin Anderson                                    020 7074 1800

Robert Speed                                                    [e-mail]

Deborah Walter                                                  [e-mail]

Notes for Editors

Deltex Medical manufactures and markets the CardioQ-ODMÔ system. CardioQ-ODM changes the way doctors care for surgical patients allowing them to recover faster and leave hospital sooner and in better health than they otherwise would do. The performance of the system has been validated through independently conducted, randomised controlled clinical trials and is being translated into routine clinical practice in leading hospitals around the world.

CardioQ-ODM comprises a monitor and a single patient disposable probe. The probe is placed into the oesophagus through either the mouth or nose and the tip positioned facing the adjacent descending aorta. A low frequency ultrasound signal, generated by the monitor, is bounced off the blood travelling down the aorta and the Doppler principle is used to determine the velocity of the blood flow, expressed in distance per cardiac cycle - 'Stroke Distance'. The monitor also calculates the amount of time that blood is flowing down the aorta as a proportion of a cardiac cycle - 'Flow Time'.

The monitor uses a validated proprietary nomogram to extrapolate volumetric data (Stroke Volume, Cardiac Output etc) from the directly measured flow velocity. The nomogram utilises the patient's age weight and height, effectively to estimate the size of the aorta in which the velocity of the flow is being measured. Crucially this means that any reported relative change in Stroke Volume is absolutely identical to the relative change in the directly measured flow velocity variable of Stroke Distance. CardioQ-ODM immediately and reliably identifies even very small changes in the blood flow velocity allowing doctors to intevene earlier and on smaller changes than with any other approach.

Intra-operative individualised Doppler guided fluid management entails insertion and focusing of the probe to obtain a baseline reading, giving a small (200 to 250 ml) fluid challenge directly into the vascular system and seeing if Stroke Volume (or Stroke Distance) increases by more than 10%. If the increase is more than 10%, repeat fluid boluses are administered until such time as the increase is less than 10%: after this no further fluid is given unless Stroke Volume falls by more than 10% - the process is designed to achieve and maintain the individual patient's optimal Stroke Volume. CardioQ-ODM is also used during surgery to guide administration of vaso-active agents such as inotropes.

The CardioQ-ODM helps patients by enabling doctors to reduce the complications that arise from a medical condition that is common to almost all patients having surgery and many others in intensive care or arriving in the accident and emergency department. This condition is known as hypovolaemia - a reduction in circulating blood volume - and in surgical patients arises as a direct consequence of the combined effects of pre-operative starvation, the anaesthetic agents and the blood and fluid losses associated with the surgical procedure itself. Hypovolaemia means that the body struggles to get sufficient blood to the tissues and vital organs which are consequently starved of essential oxygen. This can cause medical complications including peripheral and major organ failure, which if not dealt with quickly can lead to severe compromise or even death.

There are already over 2,000 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 200 clinical publications on the use of the CardioQ-ODM which have repeatedly:-

·    Validated the results of CardioQ-ODM against known standards for measuring cardiac output

·    Proved that CardioQ-ODM works in a wide range of surgical procedures

·    Proved that CardioQ-ODM delivers 50% or more reductions in post-operative complications and 25% or more reductions in length of hospital stay: better care at lower cost.

The SupraQÔis 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.

 

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