Last checked at 1 Jun 2016 07:00
1 June 2016
Deltex Medical Group plc
("Deltex Medical" or the "Company")
Excellent results from Spanish multi-centre ODM trial presented at major international clinical conference: ODM adopted into new national clinical guidelines in Spain
Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring ("ODM"), today announces the initial results of the largest ever randomised clinical trial of ODM which show substantial reductions in post-operative complications.
A group of doctors from Spain, led by Professor Jose Maria Calvo Vecino, presented the findings from their 450 patient multi-centre randomised controlled trial to doctors attending Euroanaesthesia 2016 in London, the annual meeting of the European Society of Anaesthesia. The trial was undertaken in five hospitals and included patients undergoing gastrointestinal, urological, gynaecological and orthopaedic surgery. Professor Calvo is head of the Department of Anaesthesia and Critical Care at the Infanta Leonor Universtity Hospital in Madrid and Vice President of the Spanish Society of Anaesthesia.
The trial, the first completed multi-centre randomised controlled trial of ODM during surgery, showed:
· 72% reduction in total number of complications from 198 to 56 (p
· 45% reduction in number of patients suffering one or more complications meaning Doppler use saved 28 additional patients from suffering any complication at all (15% v 28%: p
· 2 day reduction in median length of stay (p
In addition the study found statistically significant reductions in five types of major complication:
· Acute Kidney Injury: 75% reduction (5 patients v 21)
· Cardiopulmonary oedema: 100% reduction (0 v 13)
· Pneumonia: 83% reduction (4 v 22)
· Superficial surgical site infection: 75% reduction (4 v 16)
· Deep surgical site infection: 74% reduction (6 v 23)
Intra-operative fluid management has been adopted within the Spanish Society of Enhanced Recovery ('SSER') national clinical guidelines which have been developed for major surgery, for example http://portal.guiasalud.es/contenidos/iframes/documentos/opbe/2015-07/ViaClinica-RICA_English.pdf. These guidelines note that "Monitoring with oesophagic Doppler is preferred, or else methods based on validated pulse contour analyses". The Company understands that SSER, with the backing of both national and regional health systems, intends to start rolling out their guidelines into selected hospitals during the second half of the year.
Ewan Phillips, Deltex Medical's Chief Executive, commented:
"These are superb results from the largest ever ODM randomised controlled trial. They confirm the unique ability of ODM to help doctors eliminate more than half of dangerous complications after surgery. They bring the robust evidence base for ODM right up to date and confirm both the high value and the wide applicability of our ODM products. Complications after surgery are expensive to treat and reduce post-operative survival by an average of over seven years for each patient who suffers one.
"We are pursuing a number of options to expand our business in Spain to exploit the opportunities which would follow a successful national roll-out of enhanced recovery approaches to surgery."
For further information, please contact:-
Deltex Medical Group plc | 01243 774 837 investorinfo@deltexmedical.com |
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 | |
Joint Broker Zeus Capital Limited Phil Walker Dominic Wilson
|
020 3829 5000
|
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 Medical 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.