The therapy has become common enough that hospitals can now apply for accreditation as certified VAD centers, an indication of their experience in implanting the devices and taking care of patients before and after they receive their device. This spring, U-M became one of the first few such accredited VAD centers in the nation.
The DuraHeart was invented and developed by a team led by Chisato Nojiri, M.D., Ph.D., the chief executive officer of Terumo Heart. More than a decade of research and development has led to this clinical trial and the trial in Europe, as well as a trial in Japan that may begin later this year. Pagani serves as an unpaid consultant to Terumo Heart.
The clinical trial will enroll 140 patients in a prospective, non-randomized fashion, and up to 40 hospitals may eventually take part. All of the devices are being made in Ann Arbor at Terumo Heart.
To implant a DuraHeart device, the surgeon diverts blood flow from the ailing left ventricle of the heart into a titanium tube that leads into the pumping chamber. The magnetically levitating impeller, a flat magnetic disc, acts as a paddlewheel, turning constantly as it is magnetically attracted to the turning motor within the pump housing. This pushes blood into a flexible artificial blood vessel, which is connected to the large blood vessel called the ascending aorta.
By assisting the weak left ventricle, which is the heart chamber most commonly affected by heart failure, the DuraHeart allows the heart muscle to rest. It also provides better blood flow to the body, brain and organs than a weak heart ever could - which helps patients prepare for the arduous surgery of a heart transplant.
Devices such as the HeartM
|SOURCE University of Michigan Health System|
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