Medical technology company Ventracor (VCR) said today that the US Food & Drug Administration (FDA) has recommended conditional approval for the marketing of a second generation Left Ventricular Assist Device (LVAD), developed by rival company Thoratec.
An LVAD is an implantable blood pump which is designed to improve the lives of heart failure patients.
For Ventracor the recommendation of the Thoratec Heartmate II is a major milestone in the growth of the worldwide industry for LVADs and therefore its own LVAD, the VentrAssist.
"This is the first of the new generation of LVADs to win FDA approval, and we believe this will help drive the adoption of LVAD therapy for patients in end stage heart failure," said Ventracor CEO Peter Crosby.
The VentrAssist is a third generation centrifugal flow LVAD that is market released in Europe and Australia.
Ventracor said it is the only third generation device and centrifugal LVAD in clinical trials in the US.
"The early clinical results of the VentrAssist compare very favourably with those of the Heartmate II and we are optimistic the US clinical trials of the VentrAssist will yield very positive results," said Mr Crosby.
There are now fifteen US centres that have been trained and are ready to go, including eleven centres that have transplanted the VentrAssist as part of Bridge to Transplant or Destination Therapy clinical trials.
Despite the news, Ventracor fell by 2.86% or 2 cents today to close down at 68 cents.
