More detailed information on
Introduction
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Medilec is an early stage medical device company focused on
the development of instrumentation and devices which are critical to key
aspects of the management of cardiovascular disease, the western world’s
biggest cause of death and a major focus of attention of health care providers
and governments in the western world.
The
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The
Company’s core technology – Paced Electrogram
Fractionation Analysis (PEFA) – originates from original research by Dr
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PEFA is implemented through unique
electrophysiological instrumentation and associated software developed by Medilec in order to predict the risk of Sudden Cardiac
Death (SCD). SCD can occur when there
is an abnormality in the musculature of the heart (the myocardium),
which causes arrhythmias (an irregular heart beat, including the heart
stopping). Such abnormalities occur in
patients with non-coronary heart disease (people with diseased or
disorganised heart musculature) and coronary heart disease (patients who
may suffer irregular heart rhythm following heart attack or myocardial
infarction).
Clinical need
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SCD is
a major problem and responsible for over 300,000 deaths per annum
worldwide. The majority of these deaths
are from patients with coronary heart disease, but the problem is no less acute
for non-coronary heart disease sufferers: diseases of the myocardium giving
rise to non-coronary heart disease are often genetically determined and can cause
multiple SCDs in families; 8 young people die every week from this disease through SCD in the
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Safe
and accurate prediction of SCD risk in patients remains a serious clinical and
financial challenge for health care providers.
The current method of preventing SCD involves use of the Implantable Cardioverter-Defibrillator (ICD). An ICD is a small device implanted in a
patient’s chest which is connected via leads to the heart. It will detect a potentially lethal
arrhythmia and apply a defibrillating pulse in response, thereby restoring
normal cardiac rhythm. ICDs have a high rate of rescue from such arrhythmia, but
the implantation procedure is costly (approximately £20K per procedure)
with a risk of other complications (including death).
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Current
testing methods are judged to be good at detecting patients who are not at risk
(or at very low risk) of SCD and help to eliminate many patients from the need
for expensive ICD implantations.
However, they are less able to differentiate levels of risk in the
remaining ‘positive’ group of patients so that, in reality, many more ICDs are implanted than are ever activated – at the risk of
other complications and at great cost.
In the
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The
aim of Medilec’s PEFA technology is to significantly
enhance current testing methods by differentiating and stratifying the levels
of risk of SCD. This will have obvious
benefits in the prevention of SCD, including:
- Improved
well-being of patients with cardiac disease;
- More
reliable identification of patients requiring ICD implantation;
- Freeing more
patients from the need for ICD implantation and from the attendant risks
of this procedure;
- Provision
of relief from the anxiety of dying suddenly to patients who are confirmed
to be at low risk.
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The
PEFA technology also offers significant potential for reducing ICD budgets by
avoiding unnecessary implantations, as well as the cost of dealing with the
additional complications that can arise from such procedures.
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Medilec’s business will be of significant strategic importance
as the reduction of heart disease and its impact continue to be given high
priority by governments and health care providers throughout the western
world. Our products are focused on
satisfying a significant and specialist need in the management of cardiac
disease and the unrivalled ability of the Company’s technology to meet this
need is expected to assist in the generation of significant sales revenues for Medilec.
The PEFA technique and
development status
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Medilec’s PEFA technology is uniquely able to measure detailed
aspects about the conduction of electrophysiological signals across the
heart. Using catheters containing
electrodes, which are placed in the heart, it detects the level of disorganised
conduction according to the rate at which ‘fractionated’ potentials from electrogram signals are transmitted between the electrodes:
the greater the fractionation of the potentials, the greater the deduced level
of risk of SCD.
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Clinical
studies form a critical element of the information required to implement the
PEFA technology successfully. In respect
of non-coronary heart disease applications, multi-national, multi-centre
clinical studies involving over 600 patients (
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Medilec’s managing group comprises: Robert Dixon (Chairman: ex Hollister Europe, Coloplast
A/S, Vickers Medical and Johnson & Johnson); Dr
For further information, please contact:
Medilec Ltd
Honiton,
Tel: +44 (0)1404 42455
Fax: +44 (0)1404 41455
Email: medical@staplethorne.co.uk