Deltex Medical Group PLC ODM reduces postoperative complications by 75% (3140G)
01 March 2018 - 6:01PM
UK Regulatory
TIDMDEMG
RNS Number : 3140G
Deltex Medical Group PLC
01 March 2018
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:-
Deltex Medical Group 01243 774 837
plc investorinfo@deltexmedical.com
Nigel Keen, Chairman
Ewan Phillips, Chief
Executive
Jonathan Shaw, Group
Finance Director
Nominated Adviser &
Broker
Arden Partners plc 020 7614 5900
Chris Hardie
Ciaran Walsh
Joint Broker
Turner Pope Investments 0203 621 4120
(TPI) Ltd info@turnerpope.com
Andy Thacker
Financial Public Relations
IFC Advisory Ltd 0203 934 6630
Tim Metcalfe
Graham Herring
Heather Armstrong
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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