Deltex Medical Group PLC
05 June 2007
Deltex Medical Group plc
Further update on US reimbursement coverage for oesophageal Doppler
5 June 2007 - Deltex Medical Group plc ('Deltex Medical' or 'Company'), the UK's
leading haemodynamic monitoring company, today announces further details of the
reimbursement status of oesophageal Doppler monitoring (ODM) and its CardioQ
(TM) ODM products in the USA.
The Company has confirmed with the Centers for Medicare & Medicaid Services
(CMS) that, with effect from 22 May 2007, any doctor treating a CMS patient is
entitled to claim reimbursement (payment for professional services) if they use
oesophageal Doppler monitoring (ODM) to guide fluid delivery:
• in patients in intensive care whose breathing is assisted by a
ventilator; or
• in patients undergoing surgery who require fluid management.
CMS reached its decision because it considers using ODM on these groups of
patients to be both 'reasonable and necessary'.
The Company's clinical advisers have confirmed both that a significant
proportion of patients treated in intensive care units in the USA are placed on
a ventilator at some stage and that there is growing clinical consensus that all
patients undergoing moderate and major surgery are exposed to the sorts of fluid
shifts requiring ODM-led fluid therapy; furthermore they have indicated that
there is increasing evidence that such fluid shifts are seen in all patients
undergoing surgery of any kind under general, spinal or large regional
anaesthetic.
Reimbursement rates have not yet been formalised: the process to do so typically
takes up to 18 months. In the meantime users will individually negotiate rates.
In addition to reimbursement for the treatment of elderly and poor patients, who
make up the majority of the more than 40 million people falling into the
Medicare and Medicaid population, the Company expects, as is usual practice,
that private insurance groups will follow CMS's lead and also agree to reimburse
physicians for the use of ODM.
CMS's Acting Administer Leslie V. Norwalk commented:
'(This) decision reflects CMS' commitment to using evidence-based approaches to
provide Medicare beneficiaries with reasonable and necessary medical
technologies as they evolve through innovation in the marketplace. As we
developed this decision, we used the best available medical evidence-in the form
of randomized controlled clinical trials-to re-evaluate our position on this
important non-invasive method of caring for patients in intensive care
situations.'
CMS's press release on 22 May 2007 also noted that:
'In contrast to other techniques for measuring cardiac output, the probe of the
esophageal Doppler can be inserted within minutes, requires minimal technical
skill, and is not associated with major complications.'
Deltex Medical's Chief Executive, Andy Hill commented:
'Over five million patients in the USA every year could benefit from the use of
the CardioQ. CMS's ruling is based on overwhelming clinical evidence and clearly
confirms that ODM should be the standard of care for guiding fluid delivery in
these patients.
This decision paves the way for the USA to turn evidence-based medicine into
evidence-based practice in by making use of Deltex Medical's CardioQ routine for
haemodynamic management.'
For further information, please contact:-
Deltex Medical Group plc 01243 774 837
Nigel Keen, Chairman njk@deltexmedical.com
Andy Hill, Chief Executive ahill@deltexmedical.com
Ewan Phillips, Finance Director eap@deltexmedical.com
Gavin Anderson & Company 020 7554 1400
Deborah Walter dwalter@gavinanderson.co.uk
Robert Speed rspeed@gavinanderson.co.uk
Charles Stanley Securities 020 7149 6457
Philip Davies philip.davies@csysecurities.com
Russell Cook russell.cook@csysecurities.com
Notes for Editors
Deltex Medical manufactures and markets the CardioQ monitor, which uses
disposable ultra-sound probes inserted into the oesophagus to determine the
amount of blood being pumped around the body - 'circulating blood volume'.
Reduced circulating blood volume is known as hypovolaemia, which leads to
insufficient oxygen being delivered to the organs. This causes medical
complications including peripheral and major organ failure which can lead to
death. Hypovolaemia, which is akin to severe dehydration, affects virtually
every patient having surgery because of the combined effects of pre-operative
starvation, the impact of the anaesthetic agents and trauma from the surgery
itself. Using fluids and drugs, guided by the CardioQ, to optimise the amount of
circulating blood significantly reduces post-operative complications allowing
patients to make a faster, more complete recovery and return home earlier.
The CardioQ incorporates the Company's proprietary software and a small
diameter, easy-to-use, minimally invasive, disposable oesophageal probe that is
used for transmitting and receiving an ultra-sound signal. By using this
technology, the CardioQ provides clinicians with the ability to haemodynamically
optimise critically ill patients and those undergoing routine moderate to major
surgery through the controlled administration of fluid and drugs. Haemodynamic
optimisation has been scientifically proven to improve the speed and quality of
patient recovery and reduce hospital stay.
There are already over 1,250 CardioQs currently in use in hospitals worldwide
and distribution arrangements are in place in over 30 countries. In addition,
there are currently more than 90 clinical publications on the use of the CardioQ
which have repeatedly:-
• Validated the results of the Monitor against known standards for
measuring cardiac output, demonstrating that the technology works
• Proved that the CardioQ works in a wide range of surgical procedures
• Demonstrated that the Company's technology provides significant health
and economic benefits by helping to reduce post-operative complications and
length of hospital stays by an average of 30 to 40 per cent for a wide range
of patients.
The SupraQ is 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 in a similar format and is used for
taking snapshots or monitoring over short periods.
This information is provided by RNS
The company news service from the London Stock Exchange
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