Arrow International, based here, has announced that it has received approval from the Food and Drug Administration under an investigational device exemption to begin phase I human clinical trials in the United States of its Arrow LionHeart left ventricular assist system (LVAS).
The product, which assists in the pumping function of the heart’s left ventricle, is designed to provide cardiac assist for patients with endstage heart failure who are not candidates for heart transplants. According to Arrow, the device is the first fully implantable LVAS that does not use lines or cables through the skin; it is electrically driven by a wearable battery pack that transmits power noninvasively through the skin to charge internal batteries and power the blood pump.
The phase I trial is initially limited to seven patients at up to five sites in the United States. The first U.S. implant is expected to be performed this month in Hershey, Pennsylvania, at the Milton S. Hershey Medical Center of the Penn State University Department of Surgery, whose division of artificial organs pioneered the development of the device, according to Arrow.
"The company believes that its Arrow LionHeart LVAS represents a significant advance in mechanical circulatory assist technology. Because the Arrow LionHeart is the first fully implantable ‘destination therapy’ device, the patient is likely to experience an improved quality of life for an extended period of time," Arrow said.
As of December 2000, ten patients had received the LionHeart LVAS at four European centers.
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