"The DuraHeart gives us a new, third-generation option for patients with advanced heart failure who need help to allow them to survive until they can receive a heart transplant," says Pagani, who leads the U-M Center for Circulatory Support.
He has led other national clinical trials of heart-assist devices, including the HeartMate II, which in April received approval from the U.S. Food and Drug Administration after a clinical trial. U-M now offers heart failure patients nearly a dozen different options to support their heart function, including heart transplants.
"This trial will test the DuraHeart's potential to overcome some of the issues that have been seen with other devices, including hemolysis caused by shear stress on red blood cells, and clotting risk caused by blood that does not circulate rapidly enough from all areas of the chamber," Pagani explains. "It also remains to be seen if this device offers superior durability, which might make it useful as a destination therapy that could remove the need for a heart transplant."
Shannon, whose heart has been weakening for nearly 20 years after a heart attack and clogged arteries damaged part of his heart muscle, is one of 5.3 million Americans with heart failure.
Although not all heart failure patients are candidates for a heart-assist device or a heart transplant, tens of thousands could be. At any given time, as many as 4,000 Americans are on the waiting list for a heart transplant, but only 2,100 people receive new hearts in the U.S. each year because of a shortage of suitable donor organs. Hundreds of people each year die while waiting for a heart.
In the past 20 years, many devices have
|SOURCE University of Michigan Health System|
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