CARDIOVASCULAR
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Clinical Evidence

MOMENTUM 3 is the largest LVAD trial ever conducted demonstrating excellent survival and safety outcomes with HeartMate 3™ LVAD.*1 The Continuing Access Protocol (CAP) was published in 2021 and extends the post-pivotal trial period for an additional 2 years in 1685 patients.2

Excellent Survival Rates at 2 Years

Highest published 2-year survival rate for any LVAD1,2

MOMENTUM 3 CAP Study

81% of HeartMate 3 LVAD patients improved 24 months after implant.

Improved Safety Profile

Lowest hemocompatibility-related adverse events of any LVAD**1,2

MOMENTUM 3 CAP Study

9% stroke 1% thrombosis after HeartMate 3 LVAD implant.

These Clinical Trial results are consistent with real world outcomes as seen in the INTERMACS database.3

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).1,4

MOMENTUM 3 Trial

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

Quality-of-life 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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*HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
**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. Mehra MR, Cleveland JC, Uriel N, et al. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. European Journal of Heart Failure. 2021;3:1392-1400.
  3. Teuteberg JJ, Cleveland JC, Cowger J, 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.
  4. 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.
Indications, Safety & Warnings

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