The HeartMate II is a rotary blood pump that weighs just 12 ounces and is approximately 1.5 inches in diameter and 2.5 inches long - about a fifth of the size of the commercially available HeartMate XVE. Like the HeartMate on the market now, the new device sits alongside the left ventricle and assists in pumping blood to the heart.
The new heart pump, however, is an axial flow device that provides continuous blood flow through the circulatory system in contrast to existing pulsating devices. Thoratec touts the device as easier to control, in part because of a feature that automatically regulates pumping activity based on the heart's speed. Other devices, Thoratec claims, are manually adjusted.
Because Thoratec's HeartMate device on the market now is larger and more complex, it's inappropriate for children, adolescents and some small adults and is not as durable as the smaller experimental device. Grossman said he believes the new device will extend use over the HeartMate XVE by two to three times, lasting five to eight years, and can be implanted in children.
The ongoing Phase I trial is studying the device's safety in patients awaiting transplants. But Grossman said that Thoratec will likely request that the product also be evaluated in Phase II trials for long-term use as an alternative to a heart transplant.
Thoratec hasn't included revenue projections for the HeartMate II in any short-term or long-term forecasts, nor have Wall Street analysts. Instead, Thoratec is pinning its short-term financial prospects on its existing products, particularly its HeartMate line, and a couple of other new products or uses expected to win regulatory approval within a year.
Thoratec dominates the market for ventricular assist devices. Yet companies such as World Heart Corp. of Ottawa and Oakland, Abiomed Inc. of Danvers, Ma., and MicroMed Technology Inc. of Houston seek to capture more of the business of the 100,000 or so people in the United States suffering from severe heart failure and needing heart pumping devices.
The HeartMate XVE was approved in April 2003 for use not only in patients awaiting heart transplants but also for permanent use in those who are too ill to receive a new heart, expanding Thoratec's potential patient pool and helping to boost Wall Street's expectations. Thoratec's HeartMate is the only product on the market so far to receive approval as a permanent therapy.
november 28 2003 east bay times.
VCR
ventracor limited
