CARDIOVASCULAR
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Clinical Evidence

MOMENTUM 3 is the largest LVAD trial ever conducted demonstrating unprecedented* survival and safety outcomes with HeartMate 3™ LVAD.†1

Excellent Survival Rates at 2 Years

Highest published 2-year survival rate for any LVAD in a randomized controlled trial1-3

MOMENTUM 3 Trial

79% of HeartMate 3 LVAD patients improved 24 months after implant.

 

Real-World outcomes confirm excellent survival rates‡4

Intermacs Registry

84% survival rate for HeartMate 3 LVAD patients

Improved Safety Profile

Lowest hemocompatibility-related adverse events of any LVAD§#1-3,5

MOMENTUM 3 Trial

10% stroke 1% thrombosis after HeartMate 3 LVAD implant.

Results based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.

HeartMate 3 LVAD Provides Immediate, Significant and Sustained Improvements in Functional Capacity and Quality of Life

79% of patients improved from NYHA Class IIIB/IV at baseline to NYHA Class I/II by 6 months, with sustained improvement in 80% of patients through 2 years (P< 0.0001).1,6

MOMENTUM 3 Trial

80% sustained improvement of HeartMate 3 LVAD patients through 2 years.

Quality-of-life score improved significantly and was sustained through 2 years.1

KCCQ = Kansas City Cardiomyopathy Questionnaire.

MOMENTUM 3 Trial

+30 points KCCQ score

Significant Increase in 6-Minute Walk Distance

Three silhouettes of figures walking along a football field representing the 6-minute walk test. Patients with HeartMate 3 LVAD saw over a two-fold increase in distance.

At baseline, tested patients completed the 6-minute walk test at an average of 136 meters. At 2 years after HeartMate 3™ LVAD implant, patients completed the test at an average of 323 meters.1

MOMENTUM 3 Trial

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*Based on HeartMate 3 LVAD highest published survival and lowest published stroke and thrombosis rates in a randomized controlled trial for continuous-flow LVAD category of devices in the U.S.1-3,5
HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
§For a continuous-flow LVAD in a randomized controlled trial.
INTERMACS: International Registry for Mechanically Assisted Circulatory Support.
#Key adverse events include pump thrombosis, stroke and gastrointestinal bleeding.

References

  1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Left Ventricular Assist Device-Final Report. N Engl J Med. 2019;380:1618-1627.
  2. Rogers JG, Pagani F, Tatooles A, et al. Intrapericardial left ventricular assist device for advanced heart failure. New Engl J Med. 2017;376:451-460.
  3. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.
  4. Teuteberg JJ, Cleveland JC, Cowger J, Higgins RS, et al. The Society of Thoracic Surgeons Intermacs 2019 Annual Report: the changing landscape of devices and indications. Ann Thorac Surg. 2020;109:649-660.
  5. Uriel N. Long-Term Burden of Hemocompatibility Related Adverse Events in the MOMENTUM 3 Trial: Final Analysis of the 1028 Patient Cohort. The International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting; April 4, 2019; Orlando, FL.
  6. Mehra MR. A Fully Magnetically Levitated Left Ventricular Assist Device-Final Report for the MOMENTUM 3 Trial. American College of Cardiology (ACC) Annual Meeting; March 17, 2019; New Orleans, LA.
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