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.

Improved HRAE Profile
0% pump thrombosis1

at the 6-month primary end point in the MOMENTUM 3 trial**1

Outstanding survival
89%
6-month survival1
*There is no significant difference between the HeartMate 3 and HeartMate II LVADs with regard to stroke or gastrointestinal bleeding in the MOMENTUM 3 study: 7.9% and 15.9% for the HeartMate 3 LVAD, respectively, vs 10.9% and 15.2% for the HeartMate II™ LVAD in the MOMENTUM 3 trial at 6 months.(1) **MOMENTUM 3 = Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 LVAD

Meaningful innovation driven by Full MagLevTM Flow Technology

Uniquely hemodynamic Full MagLev™ Flow Technology

  • Frictionless design
  • Wide blood flow pathways
  • Intrinsic pulsatility
HeartMate 3 LVAD has a levitating, self-centering rotor that performs self-diagnostics tens of thousands of times per second to ensure consistent centering.

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

77%

Patients improved

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.

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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.

68%

improvement

in mean KCCQ*** score (QoL scale) from baseline in the Momentum 3 Trial at 6 months1

Adverse event profile1

Adverse event profile
Adverse Events Number of Patients Percentage of Patients Number of Events
Device thrombosis 0 0% 0
Hemolysis not associated with pump thrombosis 1 0.7% 1
GI bleeding 24 15.9% 47
Stroke* 12 7.9% 12
Ischemic 8 5.3% 8
Hemorrhagic 4 2.6% 4
Bleeding requiring surgery 15 9.9% 15
Device malfunction requiring reoperation 1 0.7% 1
Driveline infection✝ 18 11.9% 21
RVAD usage 4 2.6% 4

✝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