Deltex Medical Group PLC
27 February 2007
Deltex Medical Group plc
Oesophageal Doppler Monitoring recommended for reimbursement coverage in USA
27 February 2007 Deltex Medical Group plc ('Deltex Medical' or the 'Company'),
the UK's leading haemodynamic monitoring company, today announces that
oesophageal Doppler monitoring has been recommended for reimbursement coverage
in the United States. The Deltex Medical CardioQ system is the most widely used
oesophageal Doppler monitor in the world.
The Centers for Medicare & Medicaid Services (CMS), the government body
responsible for determining coverage for the reimbursement of medical
technologies in the USA, yesterday published a favourable draft decision memo
based on an application originally submitted by Deltex Medical in mid-2006. This
application sought to reverse an existing national non-coverage determination
that oesophageal Doppler monitoring had no proven clinical benefit. This
determination was made before Deltex Medical's CardioQ technology and the
clinical evidence supporting its use was available. This pre-existing
determination effectively precluded any reimbursement for the use of the CardioQ
in the USA. The draft decision memo is available for review at:
www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=196
Under its due process CMS is obliged to publish the final decision memo not more
than sixty days after a thirty-day public consultation period that started 26
February. Only after this period will the process of negotiating the level of
reimbursement begin that, when complete, will enable hospitals and physicians to
make formal reimbursement claims.
If a technology is 'covered' it is possible for hospitals to receive a payment
(reimbursement) that covers the costs associated with the purchase and use of
that technology. In some cases coverage will also allow a physician to be
personally reimbursed for the time and skill required to use a particular
technology. While a positive coverage determination does not absolutely
guarantee that reimbursement will be granted or, if it is, that it will be at an
adequate level, it is all but impossible for reimbursement to be granted without
a positive coverage determination being in place.
Deltex Medical's chief executive, Andy Hill, commented:
'This draft decision represents an important milestone in the development of our
US business. Securing reimbursement for a new medical technology is the single
most important step in establishing it as a standard of care in the world's
largest market for medical equipment.
The decision was based on a CMS-commissioned Technology Assessment - an
extensive, independently conducted analysis of the existing body of clinical
data related to the use of oesophageal Doppler monitoring. All the data
reviewed in the Technology Assessment was from clinical trials undertaken using
Deltex Medical's products. The assessment states that using the CardioQ 'during
surgery effectively reduces total complications and length of hospital stay'.'
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 0207 554 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
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
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.