Deltex Medical Regulatory News (DEMG)

1 March 2018

Deltex Medical Group plc

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

Deltex Medical's Oesophageal Doppler Monitoring System

reduces postoperative complications by 75 per cent.

Deltex Medical Group plc (AIM: DEMG), the global leader in Oesophageal Doppler Monitoring ("ODM"), today announces the results of the largest randomised controlled trial to date of its proprietary fluid management and cardiac output ODM system.

Accepted for publication in the British Journal of Anesthesia, the FEDORA trial found use of ODM guided goal-directed haemodynamic therapy ("GDHT") during major elective surgery significantly reduces postoperative complications and length of hospital stay, adding to an already extensive evidence base for the Company's ODM technology.

Conducted by researchers in Spain and funded by the Spanish Government, the FEDORA trial was a prospective, multi-centre, randomised controlled trial aimed at evaluating the impact of ODM guided administration of intravenous (IV) fluids and vasoactive drugs on postoperative complications following major elective abdominal surgery. 420 patients were analysed as part of the trial. Patients were randomised to the GDHT group or the control group. For patients in the GDHT group, anesthetists used Deltex Medical's CardioQ-ODM+ system to guide administration of fluids, inotropes and vasopressors by monitoring stroke volume, mean arterial pressure and cardiac index.

During the 180 days post-surgery, researchers measured the incidence of moderate or severe post-operative complications in both the GDHT and control groups. They found those in the GDHT group experienced 75 per cent. fewer complications. There were statistically significant reductions of between 75 per cent. and 100 per cent. in several specific major complications including acute kidney injury, acute pulmonary oedema, respiratory distress syndrome, pneumonia, and both superficial and deep surgical site infection.

Furthermore, the number of patients suffering at least one post-operative complication was halved and median length of stay for patients in the GDHT group was two days shorter than the control group.

Lead researcher, Professor Jose María Calvo Vecino, Chief of Anesthesia and Intensive Care at the University of Salamanca, Spain, commented:

"This powerful study isolates the impact of oesophageal doppler monitoring. While clinicians understand the need to maintain optimal fluid balance and organ perfusion in patients considered to be at high risk, this study demonstrates a striking impact in the moderate risk surgical patient. Reducing overall risk of complication by half, and even more dramatic reduction in specific complications such as acute kidney injury, points to the significant potential of ODM technology if adopted as standard of care in this lower risk group."

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

"Complications after surgery are unpleasant, expensive to treat and reduce patients' post-operative survival. The ability to eliminate over half of these is of huge value to both patients and healthcare providers.

"FEDORA is the most important randomised controlled trial yet of ODM. It is not only the largest ever randomised trial, but also the first multi-centre one. It highlights that monitored administration of vaso-active drugs as well as fluids is important in optimal haemodynamic management. It also shows that the benefits of ODM are achievable in patients who are otherwise considered low or moderate risk."

The trial is online at: http://bjanaesthesia.org/article/S0007-0912(17)54207-5/fulltext 

For further information, please contact:-

Notes for Editors

Deltex Medical manufactures and markets haemodynamic monitoring technologies. Deltex Medical's proprietary ODM is the only technology to measure 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 which is proven to reduce complications suffered by patients after surgery and save hospitals the costs of treating those complications.

Deltex Medical's CardioQ-ODM+ platform also now provides clinicians with two further advanced haemodynamic monitoring technologies. High Definition Impedance Cardiography is an entirely non-invasive monitoring technology which creates an electrical field across the chest and measures the disruption to this field when the heart pumps blood. Pulse Pressure Waveform Analysis uses peripheral blood pressure signal analysis to give doctors information on changes in the circulation and is particularly suited to monitoring lower risk or haemodynamically stable patients.

Company goal

Haemodynamic management is 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 aims to provide clinicians with a single platform, a 'haemodynamic workstation', which offers them a range of technologies from simple to sophisticated to be deployed according to the patient's condition and skill and expertise of the user. Doing this will enable the Company to partner healthcare providers to support modern haemodynamic management across the whole hospital.

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.