Regulatory Trials Commence
Aortech International PLC
1 October 2001
AORTECH INTERNATIONAL PLC
New Trileaflet Heart Valve
Commencement of Regulatory Trials
AorTech International plc, the Scottish-based manufacturer of cardio-vascular
devices, announces the commencement of the regulatory testing phase of its new
synthetic trileaflet heart valve prior to the commencement of clinical trials
in patients in the latter part of 2002.
The new trileaflet heart valve, made from Elast-EonTM a novel synthetic
material, aims to surmount the current clinical problems of mechanical valves
and bioprosthetic (tissue) valves which, in the case of mechanical valves,
require daily anticoagulant treatment for patients and, in the case of
bioprosthetic valves, have a limited lifespan.
The development and testing work to date has demonstrated excellent results in
terms of the valve's performance. The formal regulatory testing will be
carried out in the European Union and in the United States to comply with the
requirements of both the European Regulatory Bodies and the FDA in the USA.
Eddie McDaid, Chief Executive of AorTech, commented:
'The excellent results of our development work to date on both the material
and the design of the valve has enabled us to reach the stage of regulatory
testing which is required prior to starting clinical trials in patients in the
latter part of next year.
'This development is indeed a milestone for AorTech and the heart valve
industry in that the new synthetic trileaflet heart valve will represent the
major innovation in replacement of diseased and damaged heart valves over the
last 25 years. This milestone could not have been reached without the
substantial work and efforts of our development teams, both in the United
Kingdom and in Australia and I take this opportunity of acknowledging their
outstanding contribution in bringing the development of this new heart valve
to this stage.'
For further details go to AorTech's website at: www.aortech.com
1 October 2001
ENQUIRIES:
Aortech International plc Tel: 01698 746 699
Eddie McDaid, Chief Executive
College Hill Tel: 020 7457 2020
Michael Padley
Nicholas Nelson