CARDIOVASCULAR
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PROVEN RESULTS, LONG TERM

The HeartMate II™ Left Ventricular Assist Device (LVAD) is designed to provide short or long-term circulatory support to intermediate-to-chronic heart failure patients. Its small, quiet pump features a simple design—with only one moving part—and can provide blood flow equivalent to that of a healthy heart.

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 years.1

The HeartMate II LVAD is indicated for both destination therapy and bridge-to-transplation in the United States and is backed by more than 10 years of data.

 

BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The HeartMate II LVAD is part of our heart failure management portfolio. Our vision is to transform the treatment of heart failure by designing technology that delivers excellent clinical outcomes and improves workflow and efficiency. Read more about our approach to heart failure management

RESOURCES AND DOCUMENTATIONS

PRODUCT MANUALS (INSTRUCTIONS FOR USE)

REIMBURSEMENT INFORMATION

REFERENCES

1. Abbott. Data on file. SJM-HM-1016-0032(3).

ONE DEVICE, TWO USES

The HeartMate II™ LVAD is indicated for use as a "bridge to transplantation" for patients waiting for a transplant heart and for "destination therapy." Destination Therapy may be an option for people who are ineligible for a heart transplant. The HeartMate II LVAD was the first LVAD device approved by the FDA for Destination Therapy, sometimes called permanent support. The HeartMate II LVAD is the most widely used and extensively studied LVAD in the world, with more than 26,600 patients implanted worldwide.1,2

PATIENT-CENTRIC FEATURES

The HeartMate II LVAD is designed for patient comfort and convenience. With its wearable design and several carrying options, the HeartMate II LVAD supports your patients’ lifestyles.

Other features and benefits:

  • Provides mean blood flow of up to 10 L/min—equal to that of a healthy heart
  • Low-dose anticoagulation regimen
  • Safe for air travel*
SAFETY BY DESIGN

The HeartMate II LVAD comes with a lightweight, pocket-sized controller that interfaces with the implanted pump. Its features are designed for safety:

  • Backup battery provides at least 15 minutes of full power in an emergency situation
  • Prioritized visual alarms provide clear, actionable instructions 
  • On-screen instructions eliminate the need for guesswork
  • Driveline diagnostic checks verify that driveline wires are intact and functional
REFERENCES

*The HeartMate II LVAS has been tested and approved for air transport, including commercial aircraft. The HeartMate II LVAS is compliant with the related FAA safety requirements and is not likely to interfere with aviation electronics, per Section 21, Category M of the RTCA document number RTCA/DO-160G.

1. Abbott data on file. SJM-HM-0817-0090.

2. Abbott data on file. SJM-HM-1016-0032(3).

BACKED BY EXTENSIVE CLINICAL DATA

The HeartMate II™ left ventricular assist device is the most widely used, extensively studied LVAD in the world.Over 26,600 patients have been implanted with the HeartMate II LVAD.2

Research has shown the HeartMate II LVAD brings an immediate and sustained reduction of heart failure symptoms3* and increases patients’ survival rates compared with medical management alone.3 In fact, some patients have lived more than 10 years with the device.2

graphic displaying survival rates between heart mate two and optimal medical management
DESTINATION THERAPY TRIAL

The destination-therapy arm of the pivotal clinical trial was a prospective, randomized evaluation of the HeartMate II LVAD. The destination therapy arm of the trial studied the device in patients ineligible for a heart transplant. The primary endpoint at two years was survival, while remaining free from stroke and the need for reoperation for pump repair or replacement. The control group were treated with the HeartMate™ XVE LVAD.

Highlights of the data included:6

  • Survival was 68% and 58% at 1 year and 2 years, respectively
  • The level of adverse events, including infection, sepsis and right heart failure, in patients implanted with the HeartMate II LVAD was lower in major categories versus patients in the control group
  • HeartMate II LVAD recipients experienced significantly improved quality of life and functional status
BRIDGE-TO-TRANSPLANTATION TRIAL

The bridge-to-transplantation arm of the pivotal clinical trial studied patients eligible for cardiac transplantation.

Highlights of the data included:7,8

  • Survival to cardiac transplantation, recovery or ongoing on HeartMate II LVAD was 79% at 18 months
  • Kaplan-Meier survival for patients who continued on LVAD support was 72% at 18 months
  • Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status
  • The incidence of major adverse events with comparable definitions, including infections, strokes and bleeding requiring surgery, was significantly lower than what was clinically observed in study of the HeartMate™ I (VE) LVAD
  • The majority of patients demonstrated vast improvement, progressing from severe heart failure symptoms even at rest to being able to resume normal activities with little or no limitation; 83% of the patients improved to NYHA Class I or II
ROADMAP CLINICAL STUDY

The ROADMAP study compared the HeartMate II LVAD and optimal medical management (OMM) on patients not yet treated with inotropic support but eligible for destination therapy. Researchers found that HeartMate II LVAD patients had higher survival and function after 12 months than their OMM counterparts. Thirty-nine percent of the HeartMate II LVAD patients were alive and on the original therapy and improved their 6-minute walking test distance by at least 75 meters, compared with 21 percent of OMM patients.9

REFERENCES

*Results from clinical trials are not directly comparable. Information provided for educational purposes only.

1. Abbott.  Data on file.  SJM-HM-0817-0090.

2. Abbott.  Data on file.  SJM-HM-1016-0032(3).

3. Rose, E. A., Gelijns, A. C., Moskowitz, A. J., Heitjan, D. F., Stevenson, L. W., Dembitsky, W., … Poirier V. L., for the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. (2001). Long-term use of a left ventricular assist device for end-stage heart failure. New England Journal of Medicine, 345(20), 1435-1443. http://www.ncbi.nlm.nih.gov/pubmed/11794191

4. Park, S. J., Milano, C. A., Tatooles, A. J., Rogers, J. G., Adamson, R. M., Steidley, D. E., … Slaughter, M. S., for the HeartMate II Clinical Investigators. (2012). Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circulation: Heart Failure, 5(2), 241-248. http://www.dx.doi.org/10.1161/CIRCHEARTFAILURE.111.963991

5. Starling, R. C., Naka, Y., Boyle, A. J., Gonzalez-Stawinski, G., John, R., Jorde, U., … Pagani, F. D. (2011). Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: A prospective study using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Journal of the American College of Cardiology, 57(19), 1890-1898. http://www.dx.doi.org/10.1016/j.jacc.2010.10.062

6. Slaughter, M. S., Rogers, J. G., Milano, C. A., Russell, S. D., Conte, J. V., Feldman, D., … Frazier, O. H., for the HeartMate II Investigators. (2009). Advanced heart failure treated with continuous-flow left ventricular assist device. New England Journal of Medicine, 361(23) 2241-2251. http://www.dx.doi.org/10.1056/NEJMoa0909938

7. Pagani, F. D., Miller, L. W., & Russell, S. D. (2009). Extended mechanical circulatory support with a continuous flow rotary left ventricular assist device. Journal of the American College of Cardiology, 54, 312-321. http://dx.doi.org/10.1016/j.jacc.2009.03.055

8. HeartMate II LVAD Instructions for Use.

9. Estep, J. D., Starling, R. C., Horstmanshof, D. A., Milano, C. A., Selzman, C. H., Shah, K. B., ... & Kasirajan, V. (2015). Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: results from the ROADMAP study. Journal of the American College of Cardiology, 66(16), 1747-1761. http://dx.doi.org/10.1016/j.jacc.2015.07.075.

 

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IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION

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Brief Summary: Prior to using these devices, please review the Instructions for Use (IFU) 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, anticoagulation therapy.

Adverse Events: 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 and myocardial infarction.

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