confidence in excellence

CONFIDENCE IN EXCELLENCE

HeartMate 3™ LVAD with Full MagLev™ Flow Technology

FEATURING: THE FULL-COHORT ANALYSIS OF THE MOMENTUM 3 TRIAL

See Important Safety Information referenced within.

THE HIGHEST SURVIVAL RATE FOR ANY LVAD IN A RANDOMIZED CONTROLLED TRIAL†,1-3

THE LOWEST HEMOCOMPATIBILITY-RELATED ADVERSE EVENT RATES OF ANY LVAD†,††,1-4

IMMEDIATE, SIGNIFICANT, AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL CAPACITY AND QUALITY OF LIFE1

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 DELIVERS UNPRECEDENTED* SURVIVAL AND SAFETY OUTCOMES**1

MOMENTUM 3 was the largest left ventricular assist device (LVAD) trial ever conducted.*** The results at 2 years show that the HeartMate 3™ LVAD continues to have:

THESE OUTCOMES REFLECT ABBOTT’S LEGACY OF DEVELOPING LIFE-CHANGING TECHNOLOGY.

WHEN IT COMES TO MAKING A MEANINGFUL DIFFERENCE IN PATIENTS’ LIVES, EXCELLENCE IS AT THE HEART OF EVERYTHING WE DO.

76.7%82.7%

SUR

VIV

AL

(%)

M O N T H S A F T E R I M P L A N T

84% HeartMate 3 - INTERMACS (2017-2018)14

82% Heart Transplant (2017)*5

79% HeartMate 3™ LVAD (2019)1

77% HeartMate II™ LVAD (2019)1

68% HeartMate II LVAD (2017)2

60% HVAD† LVAD (2017)2

58% HeartMate II LVAD DT (2009)6

24% HeartMate™ XVE LVAD (2009)6

8% OMM REMATCH (2001)7

0

100

90

80

70

60

50

40

30

20

10

06 12 18 24

EXCELLENCE IS:

LANDMARK SURVIVAL WITH HEARTMATE 3™ LVAD

THE GOAL OF THERAPY IS TO IMPROVE SURVIVAL AND QUALITY OF LIFE WHILE REDUCING COMPLICATIONS, REGARDLESS OF PRE- IMPLANT STRATEGY.8

Comparable to heart transplant survival at 2 years

OMM = Optimal Medical Management. 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.

BTC = Bridge to Candidacy. BTT = Bridge to Transplant. DT = Destination Therapy.See Important Safety Information referenced within.

OVERALL SURVIVAL BY THERAPEUTIC INTENT8

DTBTT/BTC

THE LOWEST HEMOCOMPATIBILITY-RELATED ADVERSE EVENT (HRAE) RATES FOR ANY LVAD†,††,1-4

MOMENTUM 3 2019 ¹

HeartMate 3™ LVAD (n = 515)

HeartMate II™ LVAD(n = 505)

9.9% / 0.08 (% / EPPY)

19.4% / 0.18(% / EPPY)

MOMENTUM 3 2019 ¹

HeartMate 3 LVAD (n = 515)

HeartMate II LVAD(n = 505)

1 . 4% § 13.9%§

10%

1%

S T R O K E 1

THROMBOSIS1

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.

HRAE includes bleeding > 30 days, stroke, pump thrombosis, arterial thromboembolism, non-stroke neurological event (inconclusive or hematologic in etiology). 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. See Important Safety Information referenced within.

HRAE refers to the constellation of bleeding, stroke and thrombosis events that often aggregate together in the same individual.

At 2 years nearly half of HeartMate 3 LVAD patients did not experience a hemocompatible-related adverse event.4

515 342 252 203 161505 273 190 148 114

HEARTMATE 3 HEARTMATE II

No. at Risk

E N D U R A N C E 2017 2

HVAD‡ LVAD (n = 297)


29. 7 % / 0. 29 (% / EPPY)

12.1% / 0.09 (% / EPPY)

E N D U R A N C E 2017 2

HVAD LVAD (n = 297)


6 . 4%§ § 10.7% § §

EPPY = Events per patient-year.

SUR

VIV

AL

FRE

E O

F H

RA

E (

%)

P < 0.0001 by log-rank testHR: 0.70 (95% Cl: 0.59 –0.82) P < 0.0001

M O N T H S A F T E R I M P L A N T

60

100

90

80

70

60

50

40

0

12 18 24

45 ± 2%

58 ± 2%

45 ± 2%

32 ± 2%

EXCELLENCE IS:

OUTCOMES MADE POSSIBLE BY FULL MAGLEV™ FLOW TECHNOLOGY

• FULLY LEVITATED, SELF-CENTERING ROTOR that does not require hydrodynamic or mechanical bearings

• LARGE, CONSISTENT BLOOD FLOW PATHWAYS to reduce shear stress9

• INTRINSIC PULSATILITY (30 cycles per minute) to reduce blood stasis and minimize thrombus9,10

Full MagLev™ Flow Technology maintains gentle blood handling to

minimize complications and reduce HRAEs.


167

8

STACKED RED BLOOD CELLS11

STACKED RED BLOOD CELLS11

GAP

GAP

Full MagLev Flow Technology PumpLarge consistent blood flow pathways to reduce shear stress9

Hydrodynamic Bearing PumpNarrow blood flow pathways

vs

IMMEDIATE, SIGNIFICANT AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL CAPACITY AND QUALITY OF LIFE

Significant increase in 6-minute walk distance1

24 MONTHS (n = 275)

80%+30

POINTS

323 m

OVER 2X INCREASE IN DISTANCE

136 m(approx. 149 yards) (approx. 353 yards)

at 24 months (n = 211)at baseline (n = 471)

Note: One football field = 91 m (100 yards).

INDEX HOSPITALIZATIONHEARTMATE 3™ LVAD (n = 515)

HEARTMATE II™ LVAD (n = 505) P VALUE4

Length of stay for implant hospitalization (median days) (Q1, Q3)

19(14, 25)

17(14, 24) 0.11

Days on LVAD support outside of hospital (median) (Q1, Q3)

653(333, 696)

605(259, 690) 0.008

Readmission days in the hospital (median) (Q1, Q3)

13(4, 37)

18(6, 40) 0.02

Readmissions due to any cause (EPPY) 2.26 2.47 0.03

Significantly lower hospital readmission rate and fewer readmission days compared to HeartMate II™ LVAD12


EXCELLENCE IS:

Median of 48 fewer days spent in the hospital over

2 years

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

KCCQ = Kansas City Cardiomyopathy Questionnaire.

79% of patients improved from NYHA Class IIIB/IV at baseline to NYHA Class I/II by 6 months, with sustained improvement of 80% of patients through 2 years (P < 0.0001).1,12

KCCQ Score (+5 point is meaningful)+5 small improvement+10 moderate improvement+20 large improvement

HEARTMATE 3™ LVAD SYSTEMA better experience for clinicians and patients§§§

BatteriesProvide up to 17 hours of uninterrupted power

HeartMate 3™ LVADConnected to the left side of the heart and moves oxygenated blood from the left ventricle to the rest of the body

Modular drivelineFacilitates simple replacement of externalized portion

Mobile Power Unit (MPU)Plug-in power source

Pocket controller Powers and controls the LVAD and is small enough to fit in a pocket. Includes emergency backup battery


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

*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1-4

** HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.

***Ongoing evaluation of more than 2,000 patients on short- and long-term therapy of devices in the U.S.1,5,6,13

†For a continuous-flow LVAD in a randomized controlled trial. ††Key adverse events include pump thrombosis, stroke and gastrointestinal bleeding.†††82% 2-year survival for heart transplant patients between 2009 and 2015.2

§Resulting in reoperation.§§Resulting in pump exchange.§§§Compared to HeartMate II LVAD.1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated 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. 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.

5. 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.

6. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.

7. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345(20):1435-1443.

8. Goldstein DJ. Clinical Outcomes by Intended Goal of Therapy in the MOMENTUM 3 Clinical Trial: Analysis of the Full Cohort. The International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting; April 4, 2019; Orlando, FL.

9. 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.

10. 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.

11. Abbott. Data on File.12. 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.

13. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-Food and Drug Administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS‡ registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2014;63:1751-1757.

14. Teuteberg JJ, Cleveland JC, Cowger J, et al., The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications. 2020;109:649-60.

AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000HeartMate.com

Rx OnlyBrief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

HeartMate 3™ LVAS 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.

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

HeartMate 3™ LVAS Adverse Events: Adverse events that may be associated with the use of the

HeartMate 3 Left Ventricular Assist System are: 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) or pump thrombosis.

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third party trademark, which is property of its respective owner.

© 2021 Abbott. All Rights Reserved.

MAT-2010568 v3.0 | Item approved for U.S. use only.

EMPOWERING THE TRANSFORMATION OF HEART FAILUREFrom treatment to ongoing patient management, Abbott is committed to working with you to transform heart failure and improve more patient lives.

EMBRACE EXCELLENCE EVERY DAY

INSTRUCT™ PATIENT EDUCATION PATHWAYHeartMate 3™ LVAD Post-implantScan the QR code or text LIFE to 1-844-HEART-34 (1-844-432-7834) to receive 15 daily and four additional monthly post-implant HeartMate 3™ educational messages

By choosing the HeartMate 3™ LVAD, you can help patients and their loved ones hold on to what matters most.

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