us feasibility trial results

This looks lile an abstract of what VCR will be presenting at the 16-17Sept 2007 (HFSA) conference

"Introduction: Implantable left ventricular assist devices (LVADs) benefit patients awaiting cardiac transplantation (OHT) or as destination therapy, but patients receiving currently approved devices still experience serious adverse events. The VentrAssist™ LVAD is a bearingless 3rd generation rotary device designed to increase durability and reliability. Here, we review the survival, adverse events (AE) and quality of life (QoL) of the initial US experience of this device as a bridge to transplant. Hypothesis:

The VentrAssist LVAD is ready for a pivotal trial based on survival and AE experience. Methods: This is a single arm, multi-center feasibility trial. The primary endpoint is based on a performance goal: 75% survival to OHT or alive at 180 days and listed for OHT (UNOS 1A or 1B). Secondary endpoints include AEs and QOL measured by the Minnesota Living with Heart Failure (MLHF, 0 = best; 105 = worst). Results: Since 2005, we enrolled 18 patients: mean age 51 and mean LVEF of 16.5% ± 4.6. All patients were NYHA Class IV and 88% were on inotropes. Five (28%) patients were transplanted, 2 (11%) died, and 11 (61%) remain on support (3-614 days).

At baseline the average MLHF was 72 and it improved by an average of 12.7 ± 3.6 points per month (p = 0.01). Serious AEs are provided in Figure 1. Following FDA approval for hospital discharge, 9 patients were discharged to home. Conclusions: Preliminary evidence about effectiveness and safety of the VentrAssist LVAD are promising. Operative mortality was low, as was the stroke rate, and there were no device malfunctions/failures. These results justify a large-scale U.S. trial".

It appears they has an 88% success rate.

They just need to increase the centers, increase implant rate and hence increase SALES and then the SP should take care of itself.................market does need PROOF however.