HeartMate 3 LVAD

About HeartMate 3 LVAD

The HeartMate​ 3™​ Left Ventricular Assist Device (LVAD) is a mechanical circulatory support device designed for patients with advanced heart failure. With significantly improved outcomes and survival comparable to heart transplant at 2 years, our LVAD technology is making a better future possible for many patients with advanced heart failure.*^1-3 The HeartMate​ 3 LVAD has advanced the field of LVAD therapy and is setting the standard with innovation and outstanding clinical outcomes.¹

The Full MagLev Flow Technology within the HeartMate 3 LVAD maintains gentle blood handling to minimize complications and hemocompatibility-related adverse events.

HeartMate 3 LVAD with Full MagLev Flow Technology offers:

• Fully levitated, self-centering rotor, which does not require hydrodynamic or mechanical bearings
• Large, consistent blood flow pathways, which reduces shear stress⁴
• Intrinsic pulsatility, which reduces stasis and minimize thrombus^4,5

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 adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.

Contraindications:

The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

View Indications, Safety & Warnings

HeartMate 3 LVAD Clinical Evidence

There are comprehensive clinical evidence materials available to learn about the survival rate and patient improvement associated with the HeartMate 3 LVAD. For a deep dive into the clinical data, visit the Clinical Evidence and Journal Article information.

Highlights from Long-Term MOMENTUM 3 Study

In the largest LVAD trial ever conducted, clinicians studied the safety and effectiveness of the HeartMate 3 LVAD in patients with advanced heart failure and who were indicated for mechanical circulatory support with an LVAD. The study showed:

Improved Safety Profile

Reimbursement & Coding Highlights

Our coding and reimbursement documents provide information about coverage, coding and payment, economic insights and supporting documentation for Abbott LVAD and mechanical circulatory support products.

National Coverage Determination for Ventricular Assist Devices

On December 1, 2020, the Centers for Medicare and Medicaid Services (CMS) updated the final decision memo for National Coverage Determination (NCD 20.9.1) for Ventricular Assist Devices.

CMS removed the pre-implant designations (bridge-to-transplant and destination therapy) in favor of central clinical criteria for qualification of VADs for the purpose of coverage and payment effective for dates of services on and after December 1, 2020.

To access the final decision memo and the analysis in its entirety please go to cms.gov.
 

Mechanical Circulatory Support (MCS) Coding Guide

This Medicare coding and payment guide covers the HeartMate 3™ LVAS and other mechanical circulatory support products.

Abbott Coverage and Frequently Asked Questions Guide Mechanical Circulatory Support

This guide provides coverage and reimbursement information for the implantable HeartMate 3 Left Ventricular Assist Device (LVAD) and other procedures.

HCPCS Device Category C-codes

This link offers a current list of reimbursement Healthcare Procedural Coding System Device Category C-codes.

For the full resource list, visit Reimbursement & Coding for left ventricular assist devices.

*Based on published data from separate datasets, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.

^§For a continuous-flow LVAD in a randomized controlled trial.

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. Khush KK, Cherikh WS, Chambers DC, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth Adult Heart Transplant Report-2018; Focus Theme: Multiorgan Transplantation. J Heart Lung Transplant. 2018;37:1155-1168.
3. Teuteberg JJ, Cleveland JC Jr, Cowger J, et al. The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications. Ann Thorac Surg. March 2020;109(3):649-660.
4. Bourque K, Cotter C, Dague C, et al. Design rationale and preclinical evaluation of the HeartMate 3 Left Ventricular Assist System for hemocompatibility. Am Soc Artificial Int Organs. 2016;62:375-383.
5. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the proximal and distal aorta. Artificial Organs. 2006;30:638-642.
6. Abbott data on file.
7. 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.
8. 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.
9. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.
10. 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.