World Heart Gains FDA Approval for Novacor Changes
World Heart Corp. said on Wednesday it obtained pre-market approval from the U.S. Food and Drug Administration (FDA) for engineering changes to its Novacor heart pump.
Ottawa-based World Heart said the implantable heart pump includes a quieter device and smaller, lighter, longer-lasting battery packs.
The changes to the heart pump, already commercially available in Europe, were recently approved by Health Canada.
Introduction of the new product in the U.S. and Canadian markets will begin following completion of final labeling and production of the modified systems.
Shipment is expected to begin late in the first quarter of 2004.
