Sydney, Mar 17, 2008 (ABN Newswire) - Ventracor Limited (ASX: VCR)(ADR: VTCRY) announced today that the US Food and Drug Administration (FDA) has granted unconditional approval for the US Destination Therapy Trial of the VentrAssist Left Ventricular Assist Device (LVAD).
There are now 20 hospitals in the US trained and ready to implant the VentrAssist LVAD in both the Bridge To Transplant (BTT) and Destination Therapy (DT) trials, and 17 of those have enrolled at least one patient. There have been 218 patients implanted with the VentrAssist at 32 hospitals worldwide, including three hospitals in the last month who implanted their first VentrAssist. There is over 110 years of cumulative patient experience, and the longest duration patient is still surviving 3.5 years after implant.
The CEO of Ventracor, Mr. Peter Crosby, said: "We are pleased that the granting of unconditional approval of the DT trial removes an obstacle to recruitment of reimbursement in some centres."
Ventracor is one of only two companies with unconditional approval for both a BTT and DT Clinical Trial of an LVAD in the USA. There is more clinical experience of the VentrAssist LVAD than all other implantable centrifugal LVADs combined.
Ventracor is a global medical device company which produces an implantable blood pump, the VentrAssist left ventricular assist device (LVAD), as a therapy to improve the lives of heart failure patients. Ventracor is dedicated to building partnerships with healthcare professionals to make the VentrAssist the standard-of-care worldwide.
Ventracor Limited
