The Arrow LionHeart is the first totally implantable left ventricular assist device capable of taking over the entire workload of the left ventricle. Energy from an external battery pack is transmitted across the intact skin to power the system and charge the implanted battery.
The surgery involves attaching a mechanical circulatory assist device to the patient's natural heart. At the beginning of the procedure, the surgeon creates pockets in the abdominal and chest walls to hold the blood pump assembly, the energy source to power the moisture-proof motor, motor controller and internal batteries. Then, the patient is placed on a heart-lung machine to keep blood circulating and oxygenated during the surgery, and tubes are placed to connect the patient's heart and main blood vessel to the pump. Electrical connections are made from the pump and internal coil to the internal motor controller. Once the LVAD is implanted, telemetry is used to monitor the unit. The rate of the pump is increased until the patient can be weaned from the heart-lung machine. The automatic control system is switched on and the pump completely turned on takes over operation of the patient's left ventricle creating a physiologically normal pumping heart.
In February 2001, Arrow announced that the device received FDA approval under the Investigational Device Exemption to begin Phase I human clinical trials. The first U.S. recipient of the LionHeart received the device on Feb. 28, 2001, at Penn State Milton S. Hershey Medical Center. On July 26, Penn State Hershey Medical Center reported that the first U.S. patient died.
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Contact: Valerie Gliem
vgliem@psu.edu
814-865-9481
Penn State
12-Nov-2003