5
THEIR FUTURE STARTS WITH YOU HEARTMATE 3 LVAD with Full MagLev Flow Technology HEARTMATE 3LVAD WITH FULL MAGLEVFLOW TECHNOLOGY

HEARTMATE 3 LVAD WITH FULL MAGLEV FLOW … · 2 heartmate 3 lvad with full maglev flow technology heartmate 3 lvad with full maglev flow technology3 excellent safety profile lowest

Embed Size (px)

Citation preview

Page 1: HEARTMATE 3 LVAD WITH FULL MAGLEV FLOW … · 2 heartmate 3 lvad with full maglev flow technology heartmate 3 lvad with full maglev flow technology3 excellent safety profile lowest

THEIR FUTURE STARTS WITH YOU

HEARTMATE 3™ LVAD with Full MagLev™ Flow Technology

HEARTMATE 3™ LVAD WITH FULL MAGLEV™ FLOW TECHNOLOGY

Page 2: HEARTMATE 3 LVAD WITH FULL MAGLEV FLOW … · 2 heartmate 3 lvad with full maglev flow technology heartmate 3 lvad with full maglev flow technology3 excellent safety profile lowest

83% 78%SU

RVIV

AL (%

)

100

90

80

70

60

50

40

30

20

10

0

0 6 12 18 24MONTHS AFTER IMPLANT

83%HeartMate 3 LVAD (2018)1

76% HeartMate II™ LVAD (2018)1

68%HeartMate II LVAD (2017)3

24% HeartMate XVE (2009)5

82%Heart Transplant‡6

41%OMM (2017)3

1H E A R T M AT E 3 LVA D W I T H F U L L M A G L E V F L O W T E C H N O L O G Y

N OW CO M PA R A B L E TO T R A N S PL A N T S U RV I VA L AT 2 Y E A R S ‡6

HEARTMATE 3™ LVAD DELIVERS UNPRECEDENTED* SURVIVAL AND SAFETY OUTCOMES**1

LANDMARK SURVIVAL WITH HEARTMATE 3™ LVAD

NOW APPROVED FOR DESTINATION THERAPYThe 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 patients with advanced refractory left ventricular heart failure.

U N PR EC E D E N T E D S U RV I VA L AT 2 Y E A R S 1

In the MOMENTUM 3 trial, the largest LVAD trial ever conducted,*** the HeartMate 3 LVAD demonstrated at 2 years:

The highest published 2-year survival rate and the lowest published stroke and thrombosis rates for continuous-flow LVADs1-5

S U PE R I O R E V E N T-FR E E S U RV I VA L AT 2 Y E A R S (PR I M A RY E N D P O I N T ) † † †1

HeartMate 3 LVAD outcomes made possible by Full MagLev™ Flow Technology.

83%SURVIVAL1

10%STROKE1

1%THROMBOSIS †1

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. Please refer to the HeartMate II and HeartMate 3 LVAD Instructions for Use about indications, contraindications, adverse events, warnings, and precautions.

Page 3: HEARTMATE 3 LVAD WITH FULL MAGLEV FLOW … · 2 heartmate 3 lvad with full maglev flow technology heartmate 3 lvad with full maglev flow technology3 excellent safety profile lowest

3H E A R T M AT E 3 LVA D W I T H F U L L M A G L E V F L O W T E C H N O L O G Y2 H E A R T M AT E 3 LVA D W I T H F U L L M A G L E V F L O W T E C H N O L O G Y

EXCELLENT SAFETY PROFILE

LOWE S T P U B L I S H E D S T R O KE A N D T H R O M B O S I S R AT E S FO R CO N T I N U O U S -FLOW LVA Ds1 - 5

OPTION 1

OUTCOMES MADE POSSIBLE BY FULL MAGLEV™ FLOW TECHNOLOGY

• Fully levitated, self-centering rotor that does not require hydrodymamic or mechanical bearings

• Large, consistent blood flow pathways to reduce shear stress7

• Intrinsic pulsatility to reduce blood stasis and minimize thrombus7,8

Full MagLev Flow Technology maintains gentle blood handling to minimize complications and reduce hemocompatibility-related adverse events.

H E A R TM AT E 3 LVA D G A S T R O I N T E S T I N A L B L E E D I N G ( 27 %) I S S I M I L A R TO OT H E R LVA D s , WH I L E M A I N TA I N I N G M I N I M A L P UM P T H R O M B O S I S . 1

MOMENTUM 3 2018¹

HeartMate 3™ LVAD (n = 189)

HeartMate II™ LVAD(n = 172)

10.1% / 0.08 Stroke (% / EPPY)

19.2% / 0.18Stroke (% / EPPY)

ENDURANCE 2017²

HVAD§ LVAD(n = 296)

HeartMate II LVAD(n = 149)

29.7% / 0.29 Stroke (% / EPPY)

12.1% / 0.09 Stroke (% / EPPY)

MOMENTUM 3 2018¹

HeartMate 3 LVAD (n = 190)

HeartMate II LVAD(n = 176)

1.1% Pump Thrombosis (%)

15.7% Pump Thrombosis (%)

ENDURANCE 2017²

HVAD§ LVAD(n = 295)

HeartMate II LVAD(n = 149)

6.4% Pump Thrombosis (%)

10.7% Pump Thrombosis (%)

HeartMate 3 LVAD stroke rates decreased after 6 months, with a 0.04 EPPY from 6 months through 2-year follow-up. EPPY = Events Per Patient Year.

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. Please refer to the HeartMate II and HeartMate 3 LVAD Instructions for Use about indications, contraindications, adverse events, warnings, and precautions.

10%STROKE1

1%THROMBOSIS†1

Page 4: HEARTMATE 3 LVAD WITH FULL MAGLEV FLOW … · 2 heartmate 3 lvad with full maglev flow technology heartmate 3 lvad with full maglev flow technology3 excellent safety profile lowest

78%

HEARTMATE 3™ LVAD SYSTEM

A better experience for clinicians and patients

4 H E A R T M AT E 3 LVA D W I T H F U L L M A G L E V F L O W T E C H N O L O G Y

OPTION 2

MAKING A MEANINGFUL DIFFERENCE IN PATIENTS’ LIVES

6 MONTHS (n = 161)

S I G N I FI C A N T I M PR OV E M E N T I N N E W YO R K H E A R T A S S O C I AT I O N (N Y H A ) FU N C T I O N A L C L A S S 1

IMPROVED QUALIT Y OF LIFE¹

28 POINT IMPROVEMENT in KCCQ overall summary score at 3 months was sustained out to 2 years (P < 0.0001).

REDUC TION IN REHOSPITALIZ ATIONS⁹

• 8.3 FEWER hospital days• 51% REDUCTION in average cumulative

cost per patient-year

S I G N I FI C A N T I N C R E A S E I N 6 -M I N U T E WA L K D I S TA N C E 1

KCCQ = Kansas City Cardiomyopathy Questionnaire.

5H E A R T M AT E 3 LVA D W I T H F U L L M A G L E V F L O W T E C H N O L O G Y

24 MONTHS (n = 113)

79%

78% of patients improved from NYHA Class IIIB/IV at baseline to NYHA Class I/II by 6 months, with sustained improvement of 79% of patients through 2 years (P < 0.0001).1

308 m

2X INCREASE IN DISTANCE

154 m

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

(approx. 168 yards) (approx. 372 yards)at 24 months (n = 91)at baseline (n = 169)Note: One football field = 91 m (100 yards).

HeartMate 3 LVADConnected to the left side of

the heart and moves oxygenated blood from the left ventricle

to the rest of the body

Mobile Power Unit (MPU) Plug-in power source

BatteriesProvide up to 17 hours of

uninterrupted power

Modular driveline Facilitates simple replacement

of externalized portion

Pocket controller Powers and controls the

LVAD and is small enough to fit in a pocket. Includes

emergency backup battery

Page 5: HEARTMATE 3 LVAD WITH FULL MAGLEV FLOW … · 2 heartmate 3 lvad with full maglev flow technology heartmate 3 lvad with full maglev flow technology3 excellent safety profile lowest

References: 1. Mehra MR, Goldstein DJ, Uriel N, et al, for the MOMENTUM 3 Investigators. Two-year outcomes with a magnetically levitated cardiac pump in heart failure. N Engl J Med. 2018;378:1386-1395. 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. Starling RC, Estep JD, Horstmanshof DA, et al; ROADMAP Study Investigators. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: the ROADMAP Study 2-year results. JACC Heart Fail. 2017 Mar 30. 4. 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. 5. 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. 6. Lund LF, Khush KK, Cherikh WS, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-fourth Adult Heart Transplantation Report—2017; Focus theme: allograft ischemic time. J Heart Lung Transplant. 2017;36:1037-1046. 7. 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. 8. 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. 9. Mehra MR, Salerno C, Cleveland JC, et al. Health care resource use and cost implications in the MOMENTUM 3 long-term outcome study: a randomized controlled trial of a magnetically levitated cardiac pump in advanced heart failure. Circulation. 2018 May 27. pii: CIRCULATIONAHA.118.035722. doi: 10.1161/CIRCULATIONAHA.118.035722. [Epub ahead of print].

Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 HeartMate3.com St. Jude Medical is now Abbott.

Rx OnlyImportant Safety InformationBrief 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. 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 patients with advanced refractory left ventricular heart failure. Contraindications: The HeartMate 3 Left Ventricular Assist System 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: 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 device thrombosis.

Choosing HeartMate 3™ LVAD, you can go above and beyond to make a meaningful

difference in your patients’ lives.

THEIR FUTURE STARTS WITH YOU

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.

BEAT AS ONE™

*Based on HeartMate LVAD highest published survival and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1-5

** HeartMate 3TM LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.***Ongoing evaluation of more than 2000 patients on short- and long-term therapy of devices in the U.S.1,3-6

†Suspected pump thrombosis events occurred in 2 patients with the centrifugal-flow pump, but neither were confirmed.‡82% 2-year survival for heart transplant patients between 2009 and 2015.2

†††Survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device.1

™Indicates a trademark of the Abbott group of companies.§Indicates a third party trademark, which is property of its respective owner.

© 2018 Abbott. All Rights Reserved. SJM-HM3-0517-0009(2) | Item approved for U.S. use only.