(Updates with more detail and fresh share price)
World Heart Corp. (WHRT) said it has paused enrollment in a
study of its Levacor heart pump, pending regulatory approval of
refinements to the device.
Shares dropped 11% to $1.65 in recent trading. The stock has
plunged about 72% over the past year.
The pump uses magnetic levitation to suspend the spinning
impeller, its only moving part, where others use blood or
mechanical bearings. The company says that's expected to provide
improved blood compatibility. World Heart has been unprofitable as
it is focused on development of the device.
The company said Wednesday design modifications will be
"technically ready in the next two to three months," but the
timeline for their implementation depends on approval by the U.S.
Food and Drug Administration, the timing of which is uncertain.
Device makers face the possibility of further inquiry by the agency
in such reviews, which can lead to delays.
World Heart said last month it planned to make the refinements
to the device, and that enrollments would continue to be slow in
the study until they were completed.
-By Matt Jarzemsky, Dow Jones Newswires; 212-416-2240; matthew.jarzemsky@dowjones.com