The information contained herein is for general information purposes only and is not intended, and does not constitute legal, reimbursement, business, or other advice. Furthermore, it does not constitute a representation or guarantee of cost-effectiveness, and it is not intended to increase or maximize payment by any payer. Nothing in this communication should be construed as a guarantee by Abbott regarding cost effectiveness, expenditure reduction, reimbursement or payment amounts, or that reimbursement or other payment will be received. The ultimate responsibility for determining cost-effectiveness and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all claims submitted to third-party payers. Also note that actual costs for products and services and any related expenditures vary, and that the information presented herein is based on the assumptions, variables, and data presented. In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local Medicare Administrative Contractor often and should consult with legal counsel or a financial or reimbursement specialist for any questions related to cost-effectiveness, expenditure reduction, billing, reimbursement or any related issue. This information does not guarantee coverage or payment at any specific level, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. This update reproduces information for reference purposes only. It is not provided or authorized for marketing use.
INDICATIONS, SAFETY AND WARNINGS
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 patients with advanced refractory left ventricular heart failure.
HeartMate II™ LVAS Indication:
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 ventricular 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 System is 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 include, but are not limited to those 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 pump pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and pump thrombosis.