The Thoratec HeartMate II Left Ventricular Assist Device (LVAD) is a mechanical circulatory support (MCS) device intended for a broad range of advanced-stage heart failure patients. HeartMate II is designed to restore blood flow and improve survival, functional status and quality of life.
Based on the impressive clinical outcomes of the landmark HeartMate II clinical trial initiated in 2005, the HeartMate II received FDA approval in April 2008.
The HeartMate II incorporates many features specifically intended to minimize the risk of complications and to improve device durability, while enhancing patient outcomes.
- Survival. The HeartMate II was designed with the objectiveThe HeartMate II LVAS provides all energy necessary to propel blood throughout the body.of providing up to 10 years of circulatory support for a broad range of advancedstage heart failure patients.
- Quality of life. The HeartMate II is an implantable device that facilitates freedom of movement, routine daily activities, travel and even some sports like golf - leading to an improved quality of life for patients.
- Home discharge. HeartMate II patients can be discharged from the hospital, providing significant psychological and social benefits to the patient as well as cost savings to the patient and hospital alike.
- Low incidence of thromboembolic (TE) complications - stroke. The blood flow path has been optimized to ensure thorough surface washing and eliminate stagnation, and bloodcontacting surfaces are designed to avoid blood damage. As a result, the HeartMate II is durable, dependable and thromboresistant.
- Simplicity/ease-of-use. The simple design - with one moving part - contributes substantially to reliable operation.
- Durability. The device's hydrodynamic bearings are designed to provide up to 10 years of support.
The HeartMate II LVAS provides all energy necessary to propel blood throughout the body.
The HeartMate II is implanted alongside a patients native heart and designed to take over the pumping ability of the weakened heart's left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. The device is placed just below the diaphragm in the abdomen. It is attached to the aorta (the main artery that feeds blood into the entire body) from the natural heart, leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body. An external, wearable system that includes a controller and batteries is attached via an external driveline. A power cable connects the device to a small monitor, a power base unit.
The HeartMate II LVAD system can pump up to 10 liters of blood per minute, covering the full output of a healthy heart. The HeartMate II is designed to provide long-term cardiac support for patients who have advanced-stage heart failure. An axial flow device, the HeartMate II is designed to have a much longer functional life than the previous generation of devices, and to operate simply and quietly. It is also smaller and designed to be easier to implant. Bench studies project that the HeartMate II LVAD system has the capability to operate for up to 10 years.
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