FDA approves launch of CardioQ-EDM monitor in USA

RNS Number : 3138R

Deltex Medical Group PLC

02 November 2011

 



Deltex Medical Group plc

FDA approves launch of CardioQ-EDM monitor in USA

2 November 2011 - Deltex Medical Group plc ("Deltex Medical", "Company" or "Group"), the global leader in oesophageal Doppler monitoring ("ODM"), announces that it has received regulatory approval from the US Food and Drug Administration ('FDA') to market and sell its substantially updated CardioQ-EDM monitor in the United States. This monitor will be available for marketing and sale in the US with immediate effect. 

The CardioQ-EDM offers a number of user interface and patient management enhancements over the predecessor CardioQ monitor. The key additional benefits of CardioQ-EDM come from increased data sharing capability, allowing the monitor to integrate more closely with hospital systems as well as enhanced tracking and downloading of patient responses to interventions guided by the system. It is similar to the CardioQ-ODM model marketed in Europe since 2008 and also incorporates sophisticated signal screening technology.

Ewan Phillips, Deltex Medical's chief executive, commented:

"The FDA approval is welcome news and means we can now plan to introduce the enhanced functionality of the CardioQ-EDM to our existing US customers and prospects. In particular, this generation of monitor makes it easier for doctors to collect the patient and intervention data necessary to participate in projects designed to demonstrate the significant potential impact on US surgical outcomes from our technology."

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]

Jamie Cameron                                                  [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 2,300 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 250 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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