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As Thoratec Corp. launches a campaign to convince hospitals that implanting its leading commercially available heart assist device pencils out, it's keeping an eye on a smaller target, too.
The Pleasanton company has begun a Phase I trial of a smaller, longer-lasting heart device - the HeartMate II.
Doctors at the Texas Heart Institute in Houston last week implanted the experimental device into an 18-year-old man, the first patient to participate in the trial.
Thoratec plans to enroll about seven patients in the first phase of the trial in the next two to four months, and each patient will be evaluated for 30 days. Then the company intends to apply to conduct pivotal or Phase II trials, from which it would gather data for a submission with the U.S. Food and Drug Administration for marketing approval. The company believes it will have its new device on the market in 2006.
"By design, one of the most significant differences is the durability," CEO D. Keith Grossman said of the HeartMate II.
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...