The HeartMate 3™ lvad and HeartMate ii™ LVAD: innovation, experience and improved outcomes

HeartMate LVADs have been both the innovators and leaders of left ventricular assist device (LVAD) therapy for decades: Beginning with the very first FDA approved HeartMate LVAD in 1994, to the proven success of the HeartMate II LVAD in 2008, and now today, the next milestone – the HeartMate 3 LVAD.

HeartMate LVADs are intended for certain advanced heart failure patients. They are designed to restore blood flow and improve survival, functional status and quality of life.1-4

HeartMate 3 lvad: proven clinical results

The HeartMate 3 LVAD received FDA approval in 2017 and is the latest innovation in LVAD therapy. MOMENTUM 3, the largest LVAD trial ever conducted*, showed that the HeartMate 3 LVAD can reverse symptoms of heart failure — improving long-term survival, functional status and quality of life for patients.

HeartMate 3 LVAD outcomes are made possible with Full MagLev™ Flow Technology, which helps protect the blood as it flows through the pump.

Reversed Heart Failure Symptoms1

NYHA Class is a common scale that doctors use to measure heart failure symptoms. In a long-term clinical study, all patients were in NYHA Class IIIB or IV heart failure before receiving the HeartMate 3 LVAD. After being implanted with the HeartMate 3 LVAD, 79% of patients improved to NYHA Class I or II by six months. This improvement continued in 80% of patients through two years.

79% of patients improved to NYHA ClassI or II by six months1
80% of patients remained at NYHA Class I or II out to at least two years 1

Long-Term Survival1

Patients implanted with a HeartMate 3 LVAD have been shown in a clinical study to have a two-year survival rate of 79%.

83%25 two-year survival rate


Significant Increase in Six-Minute Walk Distance1

The Six-Minute Walk Test is a common way to test for your ability to perform daily physical activities. Patients who received the HeartMate 3 LVAD had a significant improvement in six-minute walk distance. Before receiving the device, patients were able to walk an average of 136 meters (about 149 yards) in six minutes. Twenty-four months after receiving the HeartMate 3 LVAD, patients were able to walk an average of 323 meters (about 353 yards) in six minutes. That’s more than two times farther in distance.

80% increase in distance

HeartMate ii lvad: Proven Long-term results

To date, over 27,000 heart failure patients have received the HeartMate II LVAD. Many have passed the 5-year milestone on therapy, with some still on therapy after 10-plus years.5 The HeartMate II LVAD was the first device approved by the FDA for Destination Therapy, sometimes called permanent support. Destination Therapy may be an option for people who are ineligible for a heart transplant. The HeartMate II LVAD is the most widely used and extensively studied LVAD in the world.6

OVER 27,000 heartmate ii™ lvad patients5
80%

of HeartMate II LVAD Recipients

reversed the symptoms
of their heart failure by
6 months, sustained
through to 24 months3

HeartMate II LVAD
Survival Rates

 77%

2-yr survival1

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RISK AND ADVERSE EVENT INFORMATION

There are serious adverse events associated with LVAD therapy. It is important to understand these risks and discuss them with your doctor. HeartMate LVADs should not be used on patients who cannot tolerate, or who are allergic to, anticoagulation therapy (blood-thinning medication). Other than the risks normally associated with major surgery and having general anesthesia, the potential complications of having a HeartMate LVAD are listed here.

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heartmate™ LVADs are available nationwide

or call us at 1-855-7-HEARTMATE

Each testimonial relates an account of an individual's response to the treatment. The patient's account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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

HeartMate 3™ LVAS Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.

HeartMate II™ LVAS 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.

HeartMate 3 and HeartMate II LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

HeartMate 3 and HeartMate II LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System include, but are not limited to those listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS), thromboembolism, pericardial fluid collection, pump pocket or pseudo pump pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and pump thrombosis.

*Ongoing evaluation of over 2,000 patients (1,028 all-comers (BTT, BTD, DT) plus 1,500 CAP).

References:

1. Mehra MR, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. N Engl J Med. 2019; 380:1618-1627.  2. Cowger J, Naka Y, Aaronson K, et al. Quality of life and functional capacity in the multicenter study of MAGLEV technology in patients undergoing mechanical circulatory support therapy with the HeartMate 3 (MOMENTUM 3) Pivotal Trial 2017.  3. Park S, Milano CA Tatooles, et al. for the HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ. Heart Failure, 2012;5(2), 241-248.  4. John R, Naka Y, Smedira N, et al. Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. Annals of Thoracic Surgery. 2011;92(4), 1406-1413.  5. Based on clinical and device tracking data as of April 12, 2019  6. Abbott data on File. SJM-HM-0817-0090.