Sydney, April 14, 2008 AEST (ABN Newswire) - Ventracor Limited (ASX:VCR)(US:VTCRY) today released the clinical results of the US Feasibility Trial of the VentrAssist(R) Left Ventricular Assist Device (LVAD). The results were presented on Saturday 12 April at the annual meeting of the International Society of Heart and Lung Transplantation (ISHLT) in Boston by Dr. Andrew Boyle, Assistant Professor of Medicine at the University of Minnesota Medical School, in Minneapolis MN.
There were 28 patients enrolled in the trial, all of whom were implanted with the VentrAssist LVAD for the Bridge to Transplant (BTT) indication, at four leading US hospitals. The performance goal was 75% of patients transplanted or continued listing for transplant at six months. In the trial, 86% of the patients were transplanted or survived to the six months end point. All patients displayed improvement in their functional status and quality of life. The profile of Serious Adverse Events (SAEs) was similar to previously published results from second generation LVADs. The longest duration patient continues to survive at well over 2.5 years. The results are consistent with those of the 33 patient CE Mark Bridge Trial that have been previously released.
The full presentation is available for download at www.ventracor.com Dr Andrew Boyle said: "All the investigators have been very pleased with the performance of the VentrAssist LVAD. Following the excellent results of the feasibility trial, we are optimistic that the bridge to transplant pivotal trial will yield similar results."
Ventracor's CEO, Mr. Peter Crosby, stated: "We are grateful for the hard work and dedication of all the US investigators that led to these results. With over 230 implants of the VentrAssist LVAD worldwide to date, recruitment in both the Bridge to Transplant and Destination Therapy clinical trials in the US is accelerating, and Ventracor moves closer to full worldwide market release of the VentrAssist."
The VentrAssist continues to be the only third generation LVAD, and the only centrifugal LVAD which has been implanted in US clinical trials. It is also one of only two devices in the US which has been implanted in both a BTT and DT trial, and there is more experience with the VentrAssist than all other third generation centrifugal LVADs, combined.