CARDIOVASCULAR
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COMPREHENSIVE SOLUTIONS FOR HEART FAILURE MANAGEMENT

BREAKTHROUGH TECHNOLOGIES WITH PROVEN CLINICAL OUTCOMES

An estimated 5.7 million American adults are affected by heart failure (HF).1 Every year in the United States, approximately 1 million patients are hospitalized with a primary discharge diagnosis of HF, with HF the leading cause of hospitalizations for adults aged 65 or older.2 The cost of treating HF in the U.S. is expected to reach $70 billion by 2030.3 In 2012, Medicare’s average cost per beneficiary with a diagnosis of heart failure exceeded $33,000 per year, approximately three times the cost of an average beneficiary.4


While the Centers for Medicare and Medicaid Services (CMS) has developed ongoing and planned reimbursement reform programs, we have dedicated our efforts to providing you with the broadest scope of technologically innovative, clinically proven and outcome-driven solutions for better heart failure management. The benefits of frequent insight and early intervention that our technologies can give you are matched only by our ability to increase efficacy while decreasing the economic cost associated with cardiovascular care.

LATEST TECHNOLOGY AND INNOVATION
CARDIOMEMS™ HF SYSTEM: OVERVIEW

Watch an introduction to the CardioMEMS™ HF System, pulmonary artery (PA) pressure monitoring.

CardioMEMS™_HF_System_pulmonary_artery(PA)pressure_ monitoring
HEARTMATE 3™ LVAD WITH FULL MAGLEV™ FLOW TECHNOLOGY

Watch a brief overview of the HeartMate 3™ LVAD with Full MagLev™ Flow Technology.

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IMPROVING OUTCOMES WITH THE CARDIOMEMS™ HF SYSTEM

Directly monitoring PA pressure with the CardioMEMS™ HF System not only notifies you if a patient’s heart failure is worsening, but also allows you to intervene earlier, adjusting medication or making other treatment changes.

In a retrospective sub-analysis of the CHAMPION trial, the 22% of study patients with preserved ejection fraction had a 50% reduction (p = 0.0001) in heart failure hospitalizations — an even greater reduction than that among study patients as a whole.7

See more CardioMEMS™ HF System evidence.

58% Reduction in HF Hospitalization^8
Quadra Assure Allure MP
PROVIDING ADDITIONAL CRT OPTIONS WITH MULTIPOINT™ PACING

MultiPoint™ Pacing (MPP™) technology, a feature of the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D) and the Quadra Allure MP™ cardiac resynchronization pacemaker (CRT-P), which pair with the Quartet™ Quadripolar LV lead , lets you pace from two left ventricular (LV) sites. Pacing from two LV sites is designed to capture more tissue and provide additional CRT options to change:

·   Pattern of depolarization

·   Engagement of areas around scar tissue

·   Hemodynamics

·   Resynchronization

Post-hoc subanalysis of the recent MPP™ technology U.S. IDE study yielded clinical evidence for improved outcomes with MPP™ technology. See the MPP™ technology U.S. IDE evidence  along with clinical evidence for our other heart failure solutions.

 

*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.9-12

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

REFERENCES

1. Mozaffarian, D., Benjamin, E. J., Go, A., A., Arnett, D. K., Blaha, M. J., Cushman, M., ... Truner, M. B. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee, (2015). Heart disease and stroke statistics—2016 update: A report from the American Heart Association. Circulation, 132, e1-e323. http://dx.doi.org/10.1161/CIR.0000000000000350
2. Akintoye, E., Briasoulis, A., Egbe, A., Dunlay, S. M., Kushwaha, S., Levine, D., Afonso, L., Mozaffarian, D., Weinberger, J., (2017). National trends in admission and in-hospital mortality of patients with heart failure in the United States (2001-2014). Journal of the American Heart Association. 6. http://dx.doi.org/10.1161/JAHA.117.006955
3. American Heart Association. (2013, April 24). Costs to treat heart failure expected to more than double by 2030. Retrieved from http://newsroom.heart.org/news/costs-to-treat-heart-failure-expected-to-more-than-double-by-2030
4. Centers for Medicare & Medicaid Services. Chronic Conditions Among Medicare Beneficiaries Chartbook: 2012 Edition. Retrieved from http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf Accessed April 23, 2014.
5. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfeld, J., Bauman, J., Adamson, P. B. (2016). Sustained efficacy of pulmonary artery pressure to guide to adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomized trial. The Lancet, 387(10017), 453-461. http://dx.doi.org/10.1016/S0140-6736(15)007233-0
6. Mehra, M. R., Goldstein, D. J., Uriel, N., Cleveland, J. C. Jr., Yuzefpolskaya, M., Salerno, C., … Dean, D. for the MOMENTUM 3 Investigators. Two-year outcomes with a magnetically levitated cardiac pump in heart failure. (2018, April 12). The New England Journal of Medicine, 378, 1386-95. https://dx.doi.org/10.1056/NEJMoa1800866
7. Adamson, P. B., Abraham, W. T., Bourge, R. C., Costanzo, M. R., Hasan, A., Yadav, C., et al. (2014). Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circulation: Heart Failure, 7 (6), 935-944. http://dx.doi.org/10.1161/circheartfailure.113.001229
8. Shavelle, D. M., Desai, A.S., Abraham, W.T., et al. (2019). Pulmonary Artery Pressure-Guided Therapy for  Ambulatory Heart Failure Patients in Clinical Practice: 1-Year Outcomes from the CardioMEMS Post-Approval Study. Presented at the American College of Cardiology conference. New Orleans, LA, March 2019. Retrieved from www.acc.org/~/media/Clinical/PDF-Files/Approved-PDFs/2019/03/15/ACC19_Slides/Mar17_Sun/1145amET_CardioMEMS-PAS-acc-2019.pdf. Accessed September 27, 2019.
9. 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.
10. 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.
11. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL.
12. 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.

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