The Arrow LionHeart™ Left Ventricular Assist System (LVAS), manufactured by Arrow International, Inc., is a "destination therapy" for patients with progressive, irreversible, end stage (Class IV) congestive heart failure. The Arrow LionHeart™ LVAS is not intended as a bridge to transplant or as a bridge to recovery of ventricular function. These patients are not eligible for heart transplantation.
One feature that sets the Arrow LionHeart™ apart is its fully implantable components that eliminate the need for wires and tubes to come through the skin, as most of the short term-Ventricular Assist Devices (VADs) do. An internal battery pack is charged through the skin. The absence of lines and wires through the skin is expected to result in a lower risk of infection, improved mobility and better quality of life.
Currently-available LVAS devices require wires and drive lines that pass through the skin and connect to an external power source. For the Arrow LionHeart™ LVAS, these lines and tethers are eliminated through the use of a transcutaneous energy transmission system, a system where power is transmitted through the skin, but without puncturing it. This power system charges an implanted battery in the patient’s abdomen, giving the patient the freedom to be completely untethered from the power source for about 20 minutes to take a shower or go for a swim. This represents a significant advance in mechanical circulatory assist technology.
The device is designed to respond to changes in the recipient’s condition and optimize the amount of blood that can be pumped to meet the patient’s needs. The Arrow LionHeart™ is made up of an assembly of pieces that allows for replacement or upgrading of individual components over time.
See how all of the LionHeart components work together to help the natural heart do its job.
Implanted Sub-System Components
The total weight of the implanted components of the Arrow LionHeart™ is 3.2 pounds, or 1.3 kilograms.
The blood pump is electrically powered and is implanted in the abdomen on the left side near the ribs. The blood pump features a motor, a pusher plate mechanism, a smooth blood sac, and two tilting disk valves for unidirectional flow. The blood pump is connected to the body’s natural circulation system.
The motor controller and internal coil control the operation of the blood pump. The blood pump and electronic motor controller are powered by either external sources or re-chargeable batteries located in the motor controller. External power is received through the un-punctured skin by the internal coil and sent to the motor controller and blood pump for continuous operation. Internal power is delivered by the motor controller’s re-chargeable batteries and allows the LVAS recipient to function totally free of the external power source for approximately 20 minutes. The motor controller is placed under abdominal wall on the right side near the ribs. The internal coil is placed just under the tissue of the chest wall.
Another component is the compliance chamber and access port which provide gas to evacuated chambers of the blood pump during its operation.
External Sub-System Components
The power transmitter/coil (PT) transfers power non-invasively through the intact skin. The PT is connected to the power pack in normal operation, and can be worn on the belt or in a pack.
The power pack with battery packs provide power to the Arrow LionHeartTM LVAS. The power pack weighs approximately eight pounds when loaded with two battery packs. The re-chargeable battery packs each provide approximately two to three hours of power for mobile operation. The power pack can be worn either with a shoulder harness, in a backpack, or pulled on a handcart.
The charger is floor-based and re-charges depleted battery packs.
The system monitor is intended to provide the clinician with the ability to check the LVAS for its functional status and operating condition during follow-up appointments and remotely, if indicated.
In addition to the system components above, additional accessories have been developed. They include: wearable accessories to facilitate mobility, surgical implant tools, and alternate power supplies.
he Penn State completely implantable total electric artificial heart is being developed in cooperation with ABIOMED, Inc., Danvers, MA.
The Penn State Heart is designed to replace a patient's irreversibly failing heart. It is implanted, along with a controller and energy transmission system, in the space left by removal of the patient's heart. Once the system is implanted in the patient, no wires, tubes or other connections protrude through the skin.
The Penn State Heart, the result of nearly 30 years of research, is one of the most successful devices to emerge from a program supported by the U.S. National Heart, Lung and Blood Institutes. The device is nearing clinical trials.