SYDNEY, Dec. 18 / MediaNet International-AsiaNet/–
* FDA grants conditional approval for US Destination Therapy trial protocol
* Innovative trial design aimed at minimising time and costs
* Recruitment anticipated to start first quarter 2007.
Ventracor (ASX: VCR) today announced the United States Food & Drug
Administration (FDA) has granted conditional approval of the protocol for the
US Destination Therapy (DT) trial of the VentrAssist.
Ventracor’s DT trial is a prospective randomized clinical trial aimed at
evaluating the effectiveness and safety of VentrAssist as long-term circulatory
support for patients with end stage heart failure who are not eligible for
cardiac transplantation.
Ventracor Chief Executive Officer Peter Crosby said: “Unlike previous US DT
Trials, Ventracor’s trial design does not require prospective randomization
only to a market released LVAD approved by the FDA for Destination Therapy.
“This revolutionary trial design has the potential to significantly shorten
the time to FDA approval for destination therapy.
Ventracor’s US DT protocol and strategy was developed in collaboration with
the FDA and the International Centre for Health Outcomes and Innovation
Research (InCHOIR) at Columbia University in New York. The DT trial will be
conducted at multiple centres.
“This approval will allow the Company to start recruitment in the DT Trial
next quarter, which is in advance of our previously stated milestones,” Mr
Crosby said.
About Ventracor
Ventracor is a global medical device company which has developed an
implantable blood pump, the VentrAssist left ventricular assist device (LVAD),
as therapy to improve the lives of heart failure patients and their families.
Ventracor is dedicated to building partnerships with healthcare professionals
to make the VentrAssist the standard-of-care worldwide.
Further information, please visit www.ventracor.com or contact:
Graeme Fallet
Chief Financial Officer or
Andrew Geddes
Investor Relations
Ventracor
Tel: + 61 2 9406 3100 or
email: info@ventracor.com
SOURCE: Ventracor
December 22, 2006
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