Introducing the HeartMate 3 LVAD
Abbott continues to set new standards with the world’s most comprehensive portfolio of innovative, evidence-based solutions for heart failure therapy supported by a deep commitment to the success of your heart failure program.
Setting a new standard for hemocompatibility
The HeartMate 3 LVAD with Full MagLev Flow Technology provides better blood handling*1 for significantly improved hemocompatibility-related adverse events (HRAE).
The HeartMate 3™ LVAD addresses the complex interconnectivity of hemocompatibility events by minimizing pump thrombosis without significantly impacting* stroke or gastrointestinal bleeding.
at the 6-month primary end point in the MOMENTUM 3 trial**1
Meaningful innovation driven by Full MagLevTM Flow Technology
Uniquely hemodynamic Full MagLev™ Flow Technology
- Frictionless design
- Wide blood flow pathways
- Intrinsic pulsatility
Designed to deliver
- Minimal Pump Thrombosis1
- Low Hemolysis1
- Reduced Blood Shearing and Stasis3
- Uninterrupted Pump Washing
HeartMate 3 LVAD makes a real difference in patients’ lives
Significant improvement in NYHA class, 6-minute walk distance, and quality of life3
Significant improvement in NYHA Class1
to NYHA Class I or II from NYHA Class III or IV (n = 127) at 6 months (p < 0.0001 compared to baseline)1
Significant increase in 6-minute walk distance
The 6-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 6-minute walk distance - they were able to walk an average of 164m prior to receiving the device, and 6 months after receiving the device improved more than 80% to 300m.
Meaningful Improvement in quality of life
***Kansas City Cardiomyopathy Questionnaire: scores range from 0 to 100, with higher scores indicating better quality of life and fewer symptoms.
in mean KCCQ*** score (QoL scale) from baseline in the Momentum 3 Trial at 6 months1
Adverse event profile1
|Adverse Events||Number of Patients||Percentage of Patients||Number of Events|
|Hemolysis not associated with pump thrombosis||1||0.7%||1|
|Bleeding requiring surgery||15||9.9%||15|
|Device malfunction requiring reoperation||1||0.7%||1|
✝Serious driveline infection HM3: 15(10%), HMII: 5(4%), p=0.0347
Indications and Important Safety Information
Indication: The HeartMate 3 Left Ventricular Assist System is indicated for providing short-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.
Contraindications: The HeartMate 3 LVAS 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 3 Left Ventricular Assist System are listed below. Adverse events are listed in anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: 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 pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis), possible pump thrombosis (has not occurred with HeartMate 3™ in the MOMENTUM 3 short term clinical study through 180 days)
References: 1. Mehra MR, Naka Y, Uriel N, et al; for the MOMENTUM 3 investigators. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2017;376(5):440-450. 2. Uriel N, Colombo PC, Cleveland JC, et al. Hemocompatibility-related outcomes in the MOMENTUM 3 trial at 6 months. Circulation. 2017;135(21):2003-2012. 3. Bourque, K., Cotter, C., Dague, C., Harjes, D., Dur, O., Duhamamel, J., Spink, K., Walsh, K., and Burke, E. Design Rationale and Preclinical Evaluation of the HeartMate3 Left Ventricular Assist System for Hemocompatibility. (2016) American Society of Artificial Internal Organs. 62:375-383