WorldHeart announces pulsatile pump implant in animal

By Elaine Rigoli

Tampa, Fla., March 30 - World Heart Corp. announced Thursday that its next-generation pulsatile left ventricular assist system (LVAS), the Novacor 2, has entered a key phase of animal testing on the development pathway toward human trials.

The successful animal implant took place Wednesday at the University of Utah in Salt Lake City.

The combination of durability and smaller size of the Novacor 2 LVAS is expected to result in less traumatic surgery, faster recovery and higher quality of life for patients, according to a news release.

The Novacor 2 LVAS is the only small, bearingless pulsatile ventricular assist device in development, the release said.

Built on Novacor LVAS technology, the blood pump is driven by direct magnetic actuation, eliminating any components subject to wear and promising enhanced long-term durability, the release said.

WorldHeart said there is a clinical need for both pulsatile and rotary devices for advanced heart failure patients, with pulsatile devices suited to providing full support or "functional" replacement for the left heart in end-stage heart failure patients and rotary devices providing partial support or "assist" in late-stage heart failure patients.

"We plan to conduct a series of animal implants in this preclinical stage over approximately the next 15 months. We are pleased to enter this advanced phase of development. We look forward to feedback from the surgeons to help us continue to refine this next-generation product before we begin the clinical trials expected to take place in late 2007," said Jal Jassawalla, president and chief executive officer, in a statement.

Heart failure affects nearly 5 million Americans of all ages and is responsible for more hospitalizations than all forms of cancer combined, the release said.

World Heart develops mechanical circulatory support systems and has headquarters in Oakland, Calif.

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