Results from head to head trial presented

RNS Number : 7475D

Deltex Medical Group PLC

11 July 2016

 

11 July 2016

Deltex Medical Group plc

("Deltex Medical", "Deltex" or "the Company")

Results from head to head trial presented

Significantly better outcomes from ODM

Deltex Medical Group plc (LSE-AIM: DEMG), the global leader in oesophageal Doppler monitoring ("ODM"), today announces initial results from the first randomised controlled trial to compare post-operative outcomes when using ODM to the most commonly used alternative technology.

Doctors from St Thomas' Hospital, London, presented the findings from their study of 127 patients at the annual meeting of The Association of Coloproctology of Great Britain and Ireland. All patients were undergoing bowel surgery, 40% of them using laparoscopic ('keyhole') techniques, within a well established enhanced recovery programme. Each was monitored with both CardioQ-ODM and an uncalibrated Pulse Pressure Waveform Analysis ("PPWA") monitor which was originally developed at St Thomas' Hospital for intensive care use about 25 years ago: in half the patients care was guided using ODM and in the other half using PPWA.

Statistically significant results included:

·      "Poor agreement": the PPWA device prompted a different intervention to that indicated by ODM two times in every five, resulting in either too much or too little fluid being given at that time

·      50% more PPWA patients required treatment with vaso-active drugs

·      ODM patients were able to get out of bed and move around on average one day sooner

·      ODM patients went home on average two days earlier (six days compared to eight days)

Prior to these results, there have been 13 studies using ODM during surgery with positive outcomes (i.e. either a statistically significant reduction in complications or length of stay or both) and eight trials using this particular PPWA device during surgery but no positive outcomes.

Ewan Phillips, Deltex Medical's Chief Executive, commented:

"These results confirm both the superiority of ODM over PPWA and that intra-operative fluid management, done properly, has a crucial role in determining optimal patient outcomes in modern enhanced recovery programmes incuding laparoscopic surgical techniques.

"This is the second important new trial to be presented since we launched our new, easier to use, TruFlow probes in May. The first trial from Spain, the largest ever randomised controlled trial of ODM, showed significant reductions in both post-operative complications and length of hospital stay and this second study shows why all the key evidence in this field comes from use of ODM."

For further information, please contact:-

Deltex Medical Group plc	01243 774 837 [e-mail]
Nigel Keen, Chairman
Ewan Phillips, Chief Executive
Jonathan Shaw, Group Finance Director Barry Curtis, Company Secretary
Nominated Adviser & Broker
Arden Partners plc	020 7614 5900
Chris Hardie
Financial Public Relations
IFC Advisory	0203 053 8671
Tim Metcalfe Graham Herring Heather Armstrong

Notes for Editors

Deltex Medical manufactures and markets haemodynamic monitoring technologies. Deltex Medical's ODM is the only technology to measure continuously blood flow in the central circulation in real time. Minimally invasive, easy to set up and quick to focus, the technology generates a low-frequency ultrasound signal, which is highly sensitive to changes in flow and measures them immediately. Deltex has been the only company in the enhanced haemodynamic space to build a robust and credible evidence base proving the clinical and economic benefits of its core technology, ODM. Randomised, controlled trials using Doppler have demonstrated that early fluid management intervention will reduce post-operative complications, reduce intensive care admissions, and reduce the length of hospital stay.

Company goal

ODM is increasingly recognised as a standard of care for patients undergoing major surgery and in critical care. The broader clinical area of haemodynamic management of which ODM is a core constituent is also now becoming widely accepted as an important major new medical modality. Consequently, the Company's focus is on maximising value from the opportunities presented as enhanced haemodynamic management is adopted into routine clinical practice around the world.

The Company is currently in the implementation phase of achieving this goal in a number of territories worldwide, operating directly in the UK, USA, Spain and Canada and through distribution arrangements in a further 30 countries.

There are over 3,200 monitors installed in hospitals around the world and over 650,000 patients have been treated to date using Deltex Medical's single patient disposable probes.

 

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