Enrollment suspended in WorldHeart's Levacor Ventricular Assist Device Bridge-To-Transplant Study

Feb 10 2011

World Heart Corporation (WorldHeart) (Nasdaq:WHRT), a developer of mechanical circulatory systems, announced today that it has paused enrollment in its Levacor Ventricular Assist Device (VAD) Bridge-To-Transplant (BTT) Study pending U.S. Food and Drug Administration (FDA) review and approval of the previously announced device refinements.

These refinements are the projection of the inflow cannula into the ventricle, the elimination of a false alarm that has led to controller exchanges and the optimization of surface finishing/coating manufacturing processes. Although WorldHeart still expects that the design modifications will be technically ready in the next two to three months, in light of ongoing communications with the FDA, the timeline for implementation is dependent on review and approval by the FDA which is uncertain.