THE MOST WIDELY USED AND EXTENSIVELY STUDIED LVAD IN THE WORLD2

The HeartMate IITM LVAD is indicated for both destination therapy and bridge-to-transplantation in the United States and backed by more than 10 years of clinical experience.2 To date, over 26,600 heart failure patients have received the HeartMate II LVAD.1 Many have passed the 5-year milestone on therapy, with some still on therapy after 10-plus years1—living proof for over a decade that HeartMate II LVAD delivers predictable surgical and clinical performance for improved outcomes.3-8

HeartMate IITM LVAD has over 900 CLINICAL OR SCIENTIFIC PUBLICATIONS2

PROVEN LONG-TERM PATIENT OUTCOMES

Research has shown the HeartMate II LVAD reverses and sustains reduction of heart failure symptoms8 and increases patients’ survival rates and quality of life compared with medical management alone.9 In fact, many patients have lived more than 10 years with the device.1

Many patients have lived MORE THAN 10 years With the HeartMate IITM LVAD1

Heartmate ii lvad delivers predictable performance for improved outcomes

Significant improvement in survival, NYHA class and 6-minute walk distance8

long-term survival rates approach those of transplantation*

TRANSPLANTATION SURVIVAL RATES10 82%2-YR SURVIVAL
HEARTMATE IITM LVAD SURVIVAL RATES8 76%2-YR SURVIVAL

Significant improvement in NYHA Class

81%

Patients improved

to NYHA Class I or II from NYHA Class III or IV at six months with improvement sustained through 24 months.8

Significant increase in 6-minute walk distance

At baseline, tested patients completed the 6-minute walk test at an average of 133 meters. At two years after HeartMate II LVAD implant, patients completed the test at an average of 334 meters. That's two and a half times as far - a 150% improvement in distance.8

Graphic of football field showing increase in walking distance after Heartmate II LVAD

HeartMate ii™ LVAD predictable adverse event profile allows surgeons to implant with confidence

Reduction in adverse events and low published stroke rates5,11,12,13

LOWERED ADVERSE EVENTS IN COMMERCIAL USE

bar chart adverse events in commercial use

REDUCTION IN THROMBUS WITH ADHERENCE TO PREVENT GUIDELINES

4.8% Confirmed pump thrombosis events at 6 months12

*Based on published data from multi-center 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™ LVAD Instructions for Use about indications, contraindications, adverse events, warnings, and precautions.



Indications and Important Safety Information

Rx Only

Brief 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 II™ Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.

Contraindications: The HeartMate II™ Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulationtherapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate II™ Left Ventricular Assist System are listed below. Adverse events are listed in decreasing order of frequency, except for death, which appears first because it is a non-reversible complication:Death, Bleeding (perioperative or late), Cardiac arrhythmia, Local infection, Respiratory failure, Device malfunction, Sepsis, Right heart failure, Driveline or pump pocket infection, Renal failure, Stroke, Neurologic dysfunction, Psychiatric episode, Peripheral thromboembolic event, Hemolysis, Hepatic dysfunction, Device thrombosis, Myocardial infarction.


References:  1. Abbott. Data as of May 10, 2018, on file. SJM-HM-1016-0032(3).  2. Abbott. Data on file. SJM-HM-0817-0090  3. 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.  4. Kirklin JK, Naftel DC, Pagani FD, et al.  Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant. 2015;34:1495-1504.  5. Estep JD, Starling RC, Horstmanshof DA, et al. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: results from the ROADMAP study. J Am Coll Cardiol. 2015;66:1747-61.  6. Rogers JG, Pagani FD, Tatooles AJ, et al.  Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med.  2017;376:451-60.  7. Grady KL, Naftel D, Stevenson L, et al. Overall quality of life improves to similar levels after mechanical circulatory support regardless of severity of heart failure before implantation. J Heart Lung Transplant. 2014:33(4):412-421.  8. Mehra MR, Goldstein DJ, Uriel N, et al. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018;378(15):1386-1395.  9.Starling RC, Estep JD, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. J Am Coll Cardiol HF. 2017;5:518-527.  10. The International Society for Heart & Lung Transplantation. Registries/Overall Heart Transplantation Statistics. Available at: http://www.ishlt.org/registries/slides.asp?slides=heartLungRegistry. Accessed September 23, 2016.  11. HeartMate II LVAD publications as of July 11, 2017.  12. Maltais S, Kilic A, Natha S, et al. PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study. J Heart Lung Transplant. 2017;36:1-12.  13. Mehra MR, Naka Y, Uriel N, et al. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017;376:440-50. 

SJM-HM-0917-0091(1)