Ventracor has received approval from the US Food & Drug Administration to begin enrolment in the US Bridge To Transplant (BTT) Pivotal Trial of the VentrAssist Left Ventricular Assist Device (LVAD).
The decision follows a review of clinical data from the Feasibility Trial submitted in March and unconditional approval of the protocol for the BTT trial, received in January.
Ventracor Chief Executive Officer Peter Crosby said: “Ventracor has achieved another major milestone towards the commercialisation of the VentrAssist and further strengthened our position in the world’s largest healthcare market.
“The BTT trial shares the same protocol as the Feasibility Trial. This means that it may be possible that the FDA will accept consolidation of data from suitable patients already implanted in the Feasibility Trial with data from patients enrolled in the BTT trial.
“The VentrAssist US BTT trial will involve up to 140 patients at leading heart transplant hospitals in America.
“The aim of the BTT trial is to evaluate the safety and efficacy of the VentrAssist in patients on the heart transplant list whose heart deteriorates before a donor heart is available.”
“The target clinical performance of the VentrAssist in the BTT trial is for 75 percent of the patients to either have a heart transplant or still be listed for heart transplant at 180 days after implant of the VentrAssist.
The Company has submitted the protocol to Institutional Review Boards (Ethics Committees) at over a dozen leading heart transplant hospitals. Enrolment of patients at these hospitals is expected to begin promptly.
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Sub-editorHeart :: Approval to start US BTT pivotal trial
by Sub-editor ( Author at Spirit India )
Posted on April 5th, 2007 at 10:41 am.
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