FDA Approves Feasibility Trials of Arrow LionHeart Left Ventricular Assist Device
The US Food and Drug Administration has approved the first US trials of the Arrow LionHeart left ventricular assist device (LVAD).
“We have been approved to do a limited study of the safety of the device in seven patients,” Dr. Walter E. Pae, Jr., from the Penn State Hershey Medical Center in Hershey, Pennsylvania, told Reuters Health. The device has been in clinical trials in Europe since 1999, he added.
The Arrow LionHeart device is unique, Dr. Pae said, because once implanted it is completely enclosed within the chest cavity. Power for the device is delivered through an external battery pack that charges internal batteries via conduction through the skin.
The Arrow LionHeart is not designed as a bridge to transplantation, but rather as a permanent implant that might allow the patient to have a quality of life better than can be achieved with transplantation, Dr. Pae said.
“For the 3 to 4 million people in the US who have heart failure, there are only a couple of thousand transplants a year, so the epidemiologic significance of treating patients with transplants is really trivial,” Dr. Pae noted. “The Arrow LionHeart device is a step toward providing hope for people who don’t qualify or are unable to get transplants.”
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