Heart Failure Indications, Safety and Warnings | Abbott
CARDIOVASCULAR
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CardioMEMS HF System

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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.

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.

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.

HeartMate 3 and HeartMate II LVAS

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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.

HeartMate 3™ LVAS 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 adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.

HeartMate II™ LVAS 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.

HeartMate 3™ and HeartMate II™ LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

HeartMate 3™ and HeartMate II™ LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: 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) and possible pump thrombosis.

HeartMate 3™ Coring Tool Indications: For the HeartMate 3™ Left Ventricular Assist System (LVAS) Indications for Use, please refer to the HeartMate 3 LVAS Instructions for Use. The HeartMate 3™ Coring Tool is intended for use with the HeartMate 3 LVAS. The HeartMate 3 Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

HeartMate 3™ Coring Tool Contraindications: The use of the HeartMate 3 Coring Tool is contraindicated in patients who are contraindicated for HeartMate 3 Left Ventricular Assist System (LVAS) therapy.

HeartMate 3™ Coring Tool Adverse Events: The following adverse events may be associated with the use of the HeartMate 3 Coring Tool. Adverse events are listed in anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: death, bleeding (perioperative or late), local infection, local ischemia, cardiac arrhythmia, stroke, peripheral thromboembolic event, neurologic dysfunction, hemolysis, sepsis.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.