CARDIOVASCULAR
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PARTNERING TO CREATE LIFE-CHANGING TECHNOLOGIES

Abbott offers the world’s leading portfolio of solutions for heart failure therapy. By partnering with you, we can work together to transform heart failure management and treatment through innovation, integration and investment.

Connect with an Abbott representative to learn about our innovative heart failure solutions and gain access to:

  • A broad spectrum of in-depth training and education programs on Abbott heart failure solutions
  • Educational meetings and other forums to encourage conversations with peers and sharing of best practices
  • Support to build communities for people living with heart failure, and their caregivers

INNOVATION ACROSS THE HEART FAILURE CONTINUUM OF CARE

By empowering the transformation of heart failure with new standards of care—from earlier detection to short- and long-term support—we join you in the quest to help patients lead fuller lives.

 

 

MULTIPOINT™ PACING

MultiPoint™ Pacing with Quadra Allure MP™ CRT-P and the Quadra Assura MP™ CRT-D1 offers more options to make non-response a non-issue. Cardiac resynchronization therapy (CRT) delivers two impulses from a single LV lead to tailor intraventricular conduction to the needs of the individual patient. MultiPoint™ Pacing is designed to deliver effective resynchronization, providing an option for patients who do not respond to traditional CRT pacing.

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MULTIPOINT™ PACING
 
CENTRIMAG™ ACUTE CIRCULATORY SUPPORT SYSTEM

The CentriMag™ Acute Circulatory Support System with Full MagLev™ Flow Technology delivers excellent hemocompatibilty2,3 across the widest range of patient applications.

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CENTRIMAG™ ACUTE CIRCULATORY SUPPORT SYSTEM
CARDIOMEMS™ HF SYSTEM

The CardioMEMS™ HF System is the first and only FDA-approved system for measuring pulmonary arterial pressure and the only heart failure management tool shown to be effective in both HFrEF and HFpEF patients.4 The CardioMEMS HF System makes a significant difference in patients’ lives by improving quality of life5 and lowering mortality6* as well as reducing heart failure hospitalizations5,7,8 and related costs.7

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CARDIOMEMS™ HF SYSTEM

 

HEARTMATE 3™ LVAD

The HeartMate 3™ LVAD with Full MagLev™ Flow Technology delivers unprecedented** survival and safety outcomes*** as demonstrated in the MOMENTUM 3 trial, the largest LVAD randomized controlled trial ever.9

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Heartmate three left ventricular assist system pump
MERLIN.NET™ PATIENT CARE NETWORK

Merlin.net™ Patient Care Network is a remote monitoring system that imports and manages cardiac information for patients with Abbott implanted cardiac rhythm management and pulmonary artery pressure monitoring devices. Clinicians upload and manage patient-device data by accessing a web interface using the Internet and a compatible browser.

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Merlin dot net patient care network
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CONTACT US

Join us to “Beat as One™” and experience first-hand our dedication to partnering with healthcare professionals to transform heart failure management and treatment through innovation, integration, and investment.

REFERENCES

*CardioMEMS™ HF System is not indicated for a reduction in mortality. Based on retrospective cohort study using the CardioMEMS HF System patients from CMS database
**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.9-13
***Compared to the HeartMate II™ LVAD in the MOMENTUM 3 trial.
1. Zanon F, Marcantoni L. Baracca E, et al. Optimization of left ventricular pacing site plus MultiPoint Pacing improves remodeling and clinical response of cardiac resynchronization therapy at 1 year. Heart Rhythm. 2016;13(8):1644-1651. http://dx.doi.org/ 10.1016/j.hrthm.2016.05.015
2. John R, Long JW, Massey HT, et al. Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support. J Thoracic Cardiovasc Surg. 2011;141;932-939.
3. John R, Liao K, Lietz K, et al. Experience with the Levitronix CentriMag circulatory support system as a bridge to decision in patients with refractory acute cardiogenic shock and multisystem organ failure. J Thoracic Cardiovasc Surg. 2007;134;351-358.
4. Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, et al. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circulation: Heart Failure. 2014;7(6):935-944.
5. Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB, for the CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. The Lancet. 2016;387(10017):453-461.
6. Abraham J, Jonsson O, Oliveira G, et al. Lower Mortality and Heart Failure Hospitalization Rates in Patients Implanted with Pulmonary Artery Pressure Sensor – A Real-world Comparative Effectiveness Study (2018) Presented at the 67th Annual Scientific Sessions of the American College of Cardiology. JACC. 2018;71(11 Supplement):A311.
7. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in “realworld” clinical practice. J Am Coll Cardiol. 2017;69(19):2357-65.
8. Shavelle DM, Desai AS, Abraham WT, et al. Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure Patients in Clinical Practice: 1-Year Outcomes from the CardioMEMS Post Approval Study. Presented at: ACC; March 17, 2019. SJMMEM- 0419-0510
9. Mehra M, Uriel N, Naka Y, et al; for the MOMENTUM 3 investigators. A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report. N Engl J Med. 2019 March 17. [Epub ahead of print].
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. Starling RC, Estep JD, Horstmanshof DA, et al; ROADMAP Study Investigators. Risk assessment and comparative effectivenessof left ventricular assist device and medical management in ambulatory heart failure patients: the ROADMAP Study 2- year results. JACC Heart Fail. 2017 Mar 30.
12. 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.
13. 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.

INDICATIONS, SAFETY AND WARNINGS

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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.

MULTIPOINT™ PACING AND SYNCAV™ CRT TECHNOLOGY 

Indications: Abbott ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT-Ds are also intended to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin™ PCS on-screen help and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

Adverse Events: Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to component failure, device programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionising radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events, including T waves, P waves or supplemental pacemaker stimuli. Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing and fear of losing pulse capability.

CARDIOMEMS™ HF SYSTEM 

Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to the following: infection, arrhythmias, bleeding, hematoma, thrombus, myocardial infarction, transient ischemic attack, stroke, death and device embolization.

CENTRIMAG™ ACUTE CIRCULATORY SUPPORT SYSTEM 

Humanitarian Device Statement: Caution: Humanitarian Device. The CentriMag™ RVAS is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure. The effectiveness of this device for this use has not been demonstrated.

CentriMag™ Blood Pump Indications [510(k) Clearance; 6-hour use]: The CentriMag Blood Pump is indicated for use only with the CentriMag™ Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).

CentriMag Blood Pump Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Blood Pump is contraindicated for use as a cardiotomy suction device. It is also contraindicated for patients who are unable or unwilling to be treated with heparin or an appropriate alternative anti-coagulant.

PediMag™ Blood Pump Indications for Use [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).

PediMag Blood Pump Contraindications [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is contraindicated for use as a cardiotomy suction device. It is also contraindicated for patients who are unable or unwilling to be treated with heparin or an appropriate alternative anti-coagulant.

HEARTMATE 3™ LEFT VENTRICULAR ASSIST SYSTEM 

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 pump thrombosis.

INDICATIONS, SAFETY AND WARNINGS

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