Each testimonial relates an account of an individual's response to the treatment. The patient's account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
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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 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.
References:
1. Causes and risks for heart failure. American Heart Association Web site. http://www.heart.org/HEARTORG/Conditions/HeartFailure/CausesAndRisksForHeartFailure/Causes-and-Risks-for-Heart-Failure_UCM_002046_Article.jsp#.WzKgZKdKjmE. Accessed October 25, 2018 2. What is heart failure? American Heart Association Web site. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed October 25, 2018. 3. Heart failure symptoms and causes. Mayo Clinic Web site. https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142. Accessed October 25, 2018. 4. Warning signs of heart failure. American Heart Association Web site. https://www.heart.org/en/health-topics/heart-failure/warning-signs-of-heart-failure. Accessed October 25, 2018. 5. Classes of heart failure. American Heart Association Web site. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure. Accessed October 25, 2018. 6. McIlvennan C, Magid K, Ambardekar A, et al. Clinical Outcomes Following Continuous-Flow Left Ventricular Assist Device: A Systematic Review. Circ Heart Fail. Oct 7 2014. 7. Mehra M, Goldstein D, Uriel N, et al. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018;378(15):1386-1395. 8. What is an LVAD? How does it work? MYLVAD Web site. https://www.mylvad.com/patients-caregivers/learn-about-lvads/intro-lvads/what-lvad-how-does-it-work. Accessed October 30, 2018.