Healthcare Industry News: THERAPY trial
News Release - December 22, 2006
US Destination Therapy Trial Protocol Approved for VentrAssist(TM) LVAD
* 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
SYDNEY, Dec. 22 (HSMN NewsFeed) -- 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.
Source: Ventracor
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