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HOPE FOR ADVANCED HEART FAILURE PATIENTS

The HeartMate II™ left ventricular assist device (LVAD) is a small, implantable heart pump designed to help the left side of the heart pump the blood the body needs.

OVERVIEW
HOW IT WORKS
FREQUENTLY ASKED QUESTIONS

 

The first device of its kind to be approved by the U.S. Food and Drug Administration (FDA) for advanced heart failure, the HeartMate II LVAD is the most widely used1 LVAD with over 26,600 patients worldwide.2

HOW AN LVAD CAN HELP HEART FAILURE PATIENTS

The HeartMate II LVAD can restore quality to the lives of advanced heart failure patients. A study showed that over 80 percent of HeartMate II LVAD device recipients were virtually free of heart failure symptoms at six months, and remained so for two years.3 Before the study, they had started out with severe symptoms, even at rest.

The HeartMate II LVAD is small enough to fit people of many sizes and ages, and is proven to work for many years. There are even several HeartMate II LVAD patients on support for more than 10 years.2

COMPLICATIONS AND RISKS

Complications of LVAD surgery are similar to the potential complications of a open-heart surgery procedure. You will be asked to sign a surgical consent form prior to the operation, as well as a consent form for blood transfusions. An LVAD should not be used in patients who cannot tolerate or are allergic to anticoagulation therapy. Common side effects include death, bleeding, cardiac arrhythmia, local infection, respiratory failure, device malfunction, sepsis, right heart failure, driveline or pump pocket infection, renal failure, stroke, neurologic dysfunction, psychiatric episode, peripheral thromboembolic event, hemolysis, hepatic dysfunction, device thrombosis and myocardial infarction.

Consult your doctor about all possible benefits and risks of an LVAD.

See important safety information.

REFERENCES

1. Abbott data on file. SJM-HM-0618-0119. Based on the number of patient implants worldwide.

2. Abbott data on file. SJM-HM-1016-0031(3).

3. Park, S. J., Milano, C. A., Tatooles, A. J., Rogers, J. G., Adamson, R. M., Steidley, E., … Slaughter, M. S. (2012). Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circulation: Heart Failure, 5, 241-248. http://dx.doi.org/10.1161/CIRCHEARTFAILURE.111.963991

HOW THE HEARTMATE II™ LVAD WORKS

The HeartMate II™ Left Ventricular Assist Device (LVAD) is designed to supplement the pumping function of the heart. The device is placed just below the diaphragm in the abdomen. It is attached to the left ventricle and the aorta (the main artery that carries oxygenated blood from the left ventricle to the entire body). An external, wearable system that includes a small controller and two batteries is attached by an external driveline. The wearable system is either worn under or on top of clothing.

HOW IS THE HEARTMATE II™ LEFT VENTRICULAR ASSIST DEVICE (LVAD) USED?

The HeartMate II LVAD may be used to support patients while they wait for a donor heart to become available. This is known as bridge to transplantation. It may also be used as a permanent option for patients who are not eligible for heart transplantation due to age or other medical conditions, known as destination therapy.

IS HEARTMATE II LVAD AN ARTIFICIAL HEART?

No. The HeartMate II LVAD is not an artificial heart, nor is it a heart replacement. The native heart is not removed. The device attaches to the heart and is designed to assist—or take over—the pumping function of the left ventricle, the main pumping chamber of the heart.

HOW LONG DOES HEARTMATE II LVAD LAST?

HeartMate II LVAD is designed to last for years. Many of the system’s recipients have been living with a single device for over ten years, and over 2,600 recipients have been supported more than five years.1

HOW LONG DOES A BATTERY CHARGE LAST?

The latest generation of batteries used to support the HeartMate II LVAD may last up to 12 hours before needing to be recharged.

WHO PAYS FOR MY HEARTMATE II LVAD?

In most cases, the HeartMate II LVAD is covered by Medicare and Medicaid. It is also covered by many private insurance plans. Speak with your insurance provider for details.

WHAT HAPPENS IF MY HEARTMATE II LVAD FAILS?

The device is designed to work for a long time. The controller is always checking the system operation and will let you know if there is a problem. The system also will be checked during your regular medical visits.

WHAT ABOUT A POWER OUTAGE?

Having extra batteries charged and ready will keep you prepared for a power outage. The Mobile Power Unit (MPU) is portable, so you can connect your HeartMate II LVAD system to power. In an emergency, your controller also has at least an additional 15 minutes of backup battery power.

REFERENCES

1. Abbott. Data on file. SJM-HM-1016-0031(3).

GENERAL SAFETY AND USE

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Find important safety and use information for our implantable devices.

RECEIVING TREATMENT

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Discover what receiving treatment for your heart failure can involve.

IMPORTANT SAFETY INFORMATION

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Brief Summary: Prior to using these devices, please review the Instructions for Use (IFU) for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The HeartMate II™ Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.

Contraindications: The HeartMate II Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate II Left Ventricular Assist System are listed below. Adverse events are listed in decreasing order of frequency, except for death, which appears first because it is a non-reversible complication: death, bleeding (perioperative or late), cardiac arrhythmia, local infection, respiratory failure, device malfunction, sepsis, right heart failure, driveline or pump pocket infection, renal failure, stroke, neurologic dysfunction, psychiatric episode, peripheral thromboembolic event, hemolysis, hepatic dysfunction, device thrombosis and myocardial infarction.

Please refer to the HeartMate II Left Ventricular Assist System Instructions for Use for additional warnings and precautions


SJM-CV WEB-0718-0076

IMPORTANT SAFETY INFORMATION
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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
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