Salt Lake City-based WorldHeart Corporation is halting efforts to commercialize the Levacor ventricular assist device (VAD) technology and will focus its resources on developing its smaller, next-generation MiFlow VAD. The company says it doesn't believe the Levacor VAD can be competitively commercialized with the bridge-to-transplant (BTT) clinical study delay. World Heart also will reduce its workforce by 42% as a result of this decision.
Although WorldHeart will not pursue further enrollment in the BTT study, it will continue to provide technical support to existing Levacor VAD recipients and clinical centers. It also expects its existing capital resources to be sufficient to allow it to advance the MiFlow program through mid-2012.
"The MiFlow VAD represents a major step in size reduction. We believe it will ultimately support a larger patient population than the late-stage heart failure population alone," says company President and CEO Alex Martin. "We are currently working on a MiFlow VAD prototype and expect to begin conducting animal studies with the MiFlow VAD by mid-2012 and human clinical trials in Europe by 2013. Thus we believe the MiFlow VAD represents significant clinical potential and value to our shareholders."
WorldHeart was established in 1996 to develop the HeartSaverVAD technologies originated by the cardiovascular devices division of the University of Ottawa Heart Institute. While the HeartSaver VAD was shelved, the technologies embodied in the Novacor LVAS and the HeartSaver VAD were amalgamated in the development of the pulsatile Novacor II LVAS, according to the company website.
- check out the WorldHeart release