Heart Failure Management Portfolio

Single- and Dual-Chamber Quadra Allure MP™ RF CRT-P with MultiPoint™ pacing and lead

Portfolio Overview

  • Improving heart failure patient outcomes in a cost-effective manner1-7
  • Monitoring pulmonary artery pressure for NYHA Class III patients
  • Enabling left ventricular pacing at the preferred site without compromising lead stability
  • Lowering rates of implant deactivation and replacement8


More Lead Options to Match Your Patients’ Anatomies

Our proven Quartet™ quadripolar LV lead is available in four lead shape options and features up to 14 pacing configurations to better match patients' anatomies.

Multi Point Pacing Options to Improve Clinical Response

MultiPoint™ Pacing: Options to Improve Clinical Response

Our MultiPoint™ pacing (MPP™) products—Quadra Allure MP™ CRT-P and Quadra Assura MP™ CRT-D—build upon the industry’s leading quadripolar technology by enabling you to pace the left ventricle from multiple locations on a single Quartet™ LV lead. MultiPoint pacing technology is designed to enable more tissue capture and provide you with additional CRT options.

MPP U.S. IDE clinical trial data subanalysis (n = 199)13 now shows:

  • Wider cathode spacing and near-simultaneous intraventricular timing delays provide the best MPP™ technology response at 87% and “super-response” at 54% (52 patients)13

See further MPP™ technology clinical evidence, including reports from international studies, and product details for Quadra Allure MP™ CRT-P and Quadra Assura MP™ CRT-D.


CardioMEMS™ HF System for Ambulatory PA Pressure Monitoring

The primary symptom leading to hospitalization for worsening HF is dyspnea due to prolonged congestion. Congestion can be assessed by checking for increased pulmonary artery (PA) pressure. HF patients often develop meaningful degrees of fluid retention or fluid redistribution despite meticulous clinical monitoring. Clinical signs often have a low sensitivity to detect increases in PA pressure, which precedes and predicts an increased risk of HF hospitalization.

The CardioMEMS™ HF System is the first and only FDA-approved HF monitor proven to significantly reduce HF hospital admissions and improve quality of life in NYHA Class III patients.14

CardioMEMS™ HF System for safe and effective heart failure management

For patients with preserved or reduced ejection fraction, CardioMEMS™ HF system reduced HF hospitalizations by 33% over an average of 18 months (p < 0.0001).17


Results From the CardioMEMS™ HF System

When used by clinicians to manage HF, the CardioMEMS HF System is:

  • Safe and reliable—98.6% of patients were free from device or system complications14
  • Clinically proven—reduced HF admissions by 33% at 18 months14
  • Proactive and personalized—patient management through direct monitoring of PA pressure and titration of medications

Operational efficiency in managing by exception includes:

  • 2.4 fewer days in the hospital, at 6 months of follow-up14
  • 1,167 patient-years of experience with the system14
  • Clinical results derived from < 1 medication changed per patient per month14

Circulatory Support for a Broad Range of Advanced HF Patients

For over 30 years, HeartMate™ left ventricular assist devices (LVADs) have led the world in delivering mechanical circulatory support devices to restore blood flow—and life—to patients with advanced heart failure.

Designed to provide long-term circulatory support to NYHA Class IIIB/IV heart failure patients, the HeartMate II™ LVAS is backed by more than 10 years of data.

Studies have shown that patients with HeartMate II LVAS have shown dramatic functional improvements for patients with advanced heart failure, with a majority reaching NYHA Class I or II over time.15

The HeartMate 3 Left Ventricular Assist System is indicated for providing short-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure. HeartMate 3™ LVAD with Full MagLev™ Flow Technology represents a new milestone in LVAD therapy by:

  • Outstanding survival:9 89% 6-month survival
  • Significant functional status improvement:9 77% of patients improved to nyha class I or II***
  • Meaningful improvement in quality of life:9 68% improvement
  • Adverse event profile including:9 0% pump thrombosis at 6-months

Self Centering HeartMate3 with Full MagLev Technology
HeartMate 2 and HeartMate 3 LVAD Modules
Close-up photograph of a microscope tray

HF Clinical Evidence

Clinical studies demonstrate that:

  • In post-hoc subanalysis of the U.S. IDE study,13 MultiPoint™ pacing has shown to be safe and effective,13 showed high response rates to quadripolar BiV pacing13 and showed that response rates were greatest in the subgroup where MPP™ technology was programmed with wide left ventricle (LV) electrode spacing and short intraventricular delay.13
  • The use of quadripolar technology lowered hospitalization rates16 and reduced mortality rates16 when compared to bipolar CRT systems.
  • Patients whose clinicians used the CardioMEMS™ HF System experienced reduced HF hospitalization by 33% at 18 months17, spent less time in the hospital18 and reported better quality of life (5 point difference in Minnesota Living with Heart Failure Questionnaire).14
  • Research has shown the HeartMate II™ LVAS brings an immediate and sustained reduction of heart failure symptoms**19 and increases patients’ survival rates compared with medical management alone;19,20 in fact, many patients live more than 10 years with the device.21
  • Out of the 1,028 patients in a recent US IDE trial, 77% of the New York Heart Association (NYHA) class III or IV patients using the HeartMate 3™ LVAD improved to class I or II at 6 months.9

See Clinical Evidence


Leading in the Advancement of Heart Failure Management

At St. Jude Medical, our vision is to transform the treatment of expensive epidemic diseases. To carry that out, we are dedicated to providing you with the broadest scope of innovative, cost-effective and outcome-driven solutions to manage heart failure.

Learn more about our approach to heart failure management.

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REFERENCES


*Subanalysis of Medicare-eligible patients only (age > 65).
**Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables.
***From NYHA Class III or IV
†At the 6-month primary endpoint in the MOMENTUM 3 trial. (MOMENTUM 3 = Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).
1. Tomassoni, G., Baker, J., Corbisiero, R., Love, C., Martin, D., Niazi, I., … & Harbert, N. (2011). Post operative performance of a novel left ventricular quadripolar electrode lead. Heart Rhythm, 8(5), S119. http://dx.doi.org/10.1016/j.hrthm.2011.03.024
2. Thibault, B., Dubuc, M., Guerra, P. G., Karst, E., Ryu, K., Paiement, P., … Farazi, T. (2011). Electrode selection to avoid phrenic stimulation with a quadripolar left heart lead. Heart Rhythm, 8(5), S68. http://dx.doi.org/10.1016/j.hrthm.2011.03.023
3. Dänschel. W., Spertzel, J., Gutleben, K. J., Kranig, W., Mortensen, P., Connelly, D., … Hallier, B. (2010). Initial clinical experience with a novel left ventricular quadripolar lead. Europace, 12(Suppl. 1), i127. http://dx.doi.org/10.1093/europace/euq127
4. Osca, J., Sanchez, J. M., Cano, O., Tejada, D., Munoz, B., Alonso, P., … Olague, J. (2011). Initial experience with a new quadripolar cable for left ventricular stimulation: Impact over phrenic nerve stimulation and pacing thresholds. Heart Rhythm, 8(5), S359. http://dx.doi.org/10.1016/j.hrthm.2011.03.031
5. Mehta, P. A., Shetty, A. K., Squirrel, M., Bostock, J., & Rinaldi, C. A. (2012). Elimination of phrenic nerve stimulation occurring during CRT: Follow-up in patients implanted with a novel quadripolar pacing lead. Journal of Interventional Cardiac Electrophysiology, 33(1), 43-49. http://dx.doi.org/10.1007/s10840-011-9598-5
6. Viani, S. M., Segreti, L., Di Cori, A., Zucchelli, G., Paperinin, L., Soldati, E., … Bongiorni, M. G. (2011).  A new quadripolar lead for left ventricular pacing: Short term reliability and future opportunities. Europace, 13(Suppl. 3). http://dx.doi.org/10.1093/europace/eur220
7. Forleo, G. B., Mantica, M., Di Biase, L., Panattoni, G., Della Rocca, D. G., Papavasileiou, L. P., … Romeo, F. (2012). Clinical and procedural outcome of patients implanted with a quadripolar left ventricular lead: Early results of a prospective multicenter study. Heart Rhythm, 9(11), 1822-1828. http://dx.doi.org/10.1016/j.hrthm.2012.07.021
8. Turakhia, M. P., Gold, M. R., Fischer, A., Sloman, L. S., Kumar, C., Dalal, N. … Cao, M., (2013). Decreased rate of left ventricular lead deactivation and replacement associated with use of quadripolar LV leads. Europace, 15(Suppl. 2), S47. http://dx.doi.org/10.1093/europace/eut169
9. Mehra, M. R., Yoshifumi, N., Uriel, N., Goldstein, D. J., Cleveland, J. C. Jr., Colombo, Paolo C., … Salerno, C. for the MOMENTUM 3 Investigators. (2016, November 16). A fully magnetically levitated circulatory pump for advanced heart failure. The New England Journal of Medicine, 376,440-50. http://dx.doi.org/10.1056/NEJMoa1610426
10. Blecker, S., Paul, M., Taksler, G., Ogedegbe, G. & Katz, S. (2013). Heart failure-associated hospitalizations in the United States. Journal of the American College of Cardiology, 61(12), 1259-1267. http://dx.doi.org/10.1016/j.jacc.2012.12.038
11. Mozaffarian, D., Benjamin, E. J., Go, A., A., Arnett, D. K., Blaha, M. J., Cushman, M., ... Turner, 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
12. Hall, M. J., Levant, S., & DeFrances, C. J. (2012, October). Hospitalization for Congestive Heart Failure: United States, 2000–2010. National Center for Health Statistics Data Brief No. 108, 1-8. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db108.htm
13. Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., & Niazi, I. (2016, May). Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA, LBCT 01-03.
14. Abraham, W. T., Adamson, P. B., Bourge, R. C., Costanzo, M. R., Stevenson, L. W., Strickland, W., … Yadav, J, S, & CHAMPION Trial Study Group. (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. The Lancet, 377(9766), 658-666. http://dx.doi.org/10.1016/S0140-6736(11)60101-3
15. Butler, K., & Farrar, D. (2006). No bearing wear detected in explanted clinical HeartMate II LVADs—implications for long-term durability and reliability. ASAIO Journal, 52(2), 33A. http://dx.doi.org/10.1097/00002480-200603000-00147
16. Turakhia, M., Cao, M., Fischer, A., Arnold, E. M., Sloman, L. S., Dalal, N., & Gold, M. (2014, June). Reduced mortality with quadripolar compared to bipolar left ventricular leads in cardiac resynchronization therapy. Presented at the meeting of the World Congress in Cardiac Electrophysiology and Cardiac Techniques, Nice, France. Retrospective analysis; not prespecified.
17. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfled, 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
18. Adams, K. F. Jr., Fonarow, G. C., Emerman, C. L., LeJemtel, T. H., Costanzo, M. R., Abraham, W. T., … Horton, D. P., & ADHERE Scientific Advisory Committee and Investigators. (2005). Characteristics and outcomes of patients hospitalized for heart failure in the United States: Rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). American Heart Journal, 149(2), 209-216. http://dx.doi.org/10.1016/j.ahj.2004.08.005
19. 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. The New England Journal of Medicine, 345(20), 1435-1443. http://dx.doi.org/10.1056/NEJMoa012175
20. 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
21. Thoratec Corp. (2014, September). Data on file. Pleasanton, CA. 

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