Established in 1976, Thoratec Corporation now offers the broadest range of products for treating chronic heart failure patients. Since merging with Thermo Cardiosystems Inc. in 2001, they have become the world leader in mechanical circulatory support. 

Thoratec develops, manufactures and markets proprietary medical devices used for circulatory support, vascular graft applications, point-of- care diagnostic test systems and skin incision products. A world leader in products to treat cardiovascular disease, Thoratec offers the broadest range of mechanical circulatory support devices available. With its strong commitment to clinical affairs and research, Thoratec Corporation is also a frontrunner in a wide range of emerging markets driven by the development of advanced technology and the approval of new therapy and product indications.

Company Mission

The Thoratec Corporation utilizes the latest technologies to create a variety of products that assist patients with failing hearts allowing them to live normal, full lives.

Products by Thoratec

• Thoratec® PVAD™ (Paracorporeal Ventricular Assist Device)
• Thoratec® IVAD™ (Implantable Ventricular Assist Device)
• HeartMate® I LVAS (Left Ventricular Assist System)
• HeartMate II® LVAS* (Left Ventricular Assist System)
• Thoratec® CentriMag® Blood Pump

On October 24, 2008, Thoratec issued a world-wide recall of the Heartmate II Left Ventricular Assist System (LVAS) with catalogue numbers 1355 and 102139. These systems have ben distributed since the beginning of clinical studies starting in November 2003. According to the FDA Recall information:

Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Anyone who has is currently supported by the HeartMate II LVAS should contact their doctor immediately so that the percutaneous lead can be assessed for wear and fatigue. There has been 27 confirmed cases where the system needed to be replaced. Five deaths have resulted in patients who were unable to receive a pump replacement.

If you or a loved one has been injured by from this defective product, contact us immediately to find out your legal rights.

HeartMate II Left Ventricular Assist System is Thoratec’s newest Left Ventricular Assist Device (LVAD). Its goal is to provide up to 10 years of circulatory support to patients suffering from heart failure. By helping maintain appropriate levels of blood flow, HeartMate II LVAS helps patients survive and live fuller lives.

How Does It Work?

The HeartMate II device is compact in size and is surgically implanted into the patient’s abdomen. It is most commonly used with patients who are suffering from chronic heart failure. Blood enters the device through a tube that is connected to the left ventrical of the heart. As the heart beats, the blood is emptied into the device and a second feature, a flexible diaphragm moved by a pusher plate, drives the blood onward to the aorta. Once the blood reaches the aorta, the main artery that supplies the body with blood, it is dispersed to the rest of the body. The HeartMate can sufficiently pump 10 liters of blood per minute, which is ample blood for the body to maintain normal activity levels.

Who Can Benefit from the HeartMate II?

Ventricular assist devices (VADs) are most commonly used with patients who are suffering from heart failure and have expended all other treatment options with little success. In most cases, the HeartMate is implemented with those patients who have reached stage IV of the disease and/or are in a chronic condition and are waiting for an available transplant.

Left ventricular assist devices (LVADs) are battery-operated mechanical pump-type devices that are surgically implanted on the upper part of the abdomen. They take blood from the left ventricle and pump it through the aorta. LVADs are becoming more common and are often used by heart failure patients who have to wait for heart transplants.

How Do LVADs Function?

Most ventricular assist devices (VADs) operate on similar principles, including the Thoratec Heartmate II. A cannula, a tube that can be inserted into the body with the purpose of delivering or removing fluid, is inserted into the apex of the appropriate ventricle. Blood passes through the ventricle to a pump and then through a tube on the device to the aorta in the case of an LVAD, or to the pulmonary artery in the case of a right ventricular assist device (RVAD). The pump is powered through a lead that connects it to a controller and power supply. In some cases, there is also a tube to vent the pump to outside air.

The Jarvik 2000 operates slightly differently – the pump is actually located inside the left ventricle and its outflow passes through the apex of the ventricle to a tube that leads to the aorta.

Major distinguishing features between the different VADs are the pump (which can vary substantially in method of operation, size, and placement), the controller, the materials used both for the pump and the associated tubes and cannulas, and the lead between the pump and the controller/power supply.

Pulsatile Pumps vs. Continuous Flow Pumps

Pumps used in VADs can be divided into two main categories – pulsatile pumps, which mimic the natural pulsing action of the heart, and continuous flow pumps.

Pulsatile VADs use positive displacement pumps. In some of these pumps, the volume occupied by blood varies during the pumping cycle, and if the pump is contained inside the body then a vent tube to the outside air is required. The only three LVADS approved by the FDA for use in the U.S. are all pulsatile pumps. All were approved between 1994 and 1998, indicating the relative maturity of this technology.

Continuous flow VADs normally use either centrifugal pumps or axial flow pumps. Both types have a central rotor containing permanent magnets. Controlled electric currents running through coils contained in the pump housing apply forces to the magnets, which cause the rotors to rotate. In the centrifugal pumps, the rotors are shaped to accelerate the blood circumferentially and thus cause it to move towards the outer rim of the pump. Whereas in the axial flow pumps, the rotors are more or less cylindrical with blades that are mostly helical, causing the blood to be accelerated in the direction of the rotor’s axis.

An important issue with continuous flow pumps is the method used to suspend the rotor. Early versions used solid bearings; however, newer pumps, some of which are approved for use in the European Union, use either electromagnetic or hydrodynamic suspension. These pumps contain only one moving part. Manufacturers claim that these methods of suspension not only virtually eliminate wear, but also reduce damage to blood cells.