btt trial

An exert from the 10th of July announcement...

US Progress
Bridge to Transplant (BTT) Trial
The Bridge To Transplant (BTT) Trial is designed to show the safety and efficacy of the
VentrAssist LVAD in a population of patients who are on the heart transplant list but whose own
heart may deteriorate before a donor heart becomes available. In this trial, the job of the
VentrAssist LVAD is to provide ongoing circulatory support to keep patients alive until heart
transplant. The BTT Trial is designed to look at the results of 140 patients, but there is an
opportunity for an “early look” before all 140 patients have reached an outcome.
There were 20 patients implanted in the BTT Trial by 31 March 2008, and with 58 patients
implanted in the 3 months since then, the enrolment rate is increasing in parallel with the
growing number of hospitals trained and participating in the trial. We expect full enrolment will
be complete well before the end of the calendar year, in line with the guidance in the 2006
Rights Issue Prospectus.
Furthermore, if the clinical results continue to track with the results reported for the Feasibility
Trial, it is possible that the “early look” will show a statistical end point earlier than originally
projected, resulting in submission of a Pre-Market Approval (PMA) Application to the US Food
and Drug Administration (FDA) by the middle of 2009.


VCR will have this early look at implant number 97 in the BTT trial. I suggest this implant number has come and gone and I think VCR will announce these results in the coming weeks/months. Hope they are around 90% like the feasability trial.