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Heart Failure and Annual Report: 15,000 Patients and Counting

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Heart Failure and Annual Report: 15,000 Patients and Counting Abbott patients who have been determined to be at prohibitive risk for (not stroke-related), hepatic dysfunction, psychiatric episode, venous *Assessment indicators are exemplars only based on the One St. Jude Medical Dr., St. Paul, MN 55117 USA mitral valve surgery by a heart team, which includes a cardiac thromboembolism, hypertension, arterial non-central nervous system surgeon experienced in mitral valve surgery and a cardiologist (CNS) thromboembolism, pericardial fluid collection, pump pocket referenced literature. Clinicians are responsible for making Tel: 1 651 756 2000 experienced in mitral valve disease, and in whom existing or pseudo pocket infection, myocardial infarction, wound dehiscence, independent, patient-specific, clinical determinations Cardiovascular.Abbott comorbidities would not preclude the expected benefit from hemolysis (not associated with suspected device thrombosis) or regarding the medical necessity of any advanced interventions Rx Only reduction of the mitral regurgitation. pump thrombosis. and for ensuring that all medical decisions are in the clinical Brief Summary: Prior to using these devices, please review • The MitraClip™ G4 System, when used with maximally tolerated best interest of the patient. the Instructions for Use for a complete listing of indications, CentriMag™ Circulatory Support System Indications [PMA guideline-directed medical therapy (GDMT), is indicated for Temporary circulatory support for up to 30 days **Based on published data from multicenter experience contraindications, warnings, precautions, potential adverse events Approval; 30-day use]: the treatment of symptomatic, moderate-to-severe or severe for one or both sides of the heart to treat post-cardiotomy patients who and separate studies, which may involve different patient and directions for use. secondary (or functional) mitral regurgitation (MR; MR ≥ Grade fail to wean from cardiopulmonary bypass, providing a bridge to decision populations and other variables. Not a head to head Gallant™ ICD and Gallant™ CRT-D Intended Use: The Implantable III per American Society of Echocardiography criteria) in patients when it is unclear whether the patient’s heart will recover or whether comparison. Data presented for informational purposes only. Cardioverter Defibrillator (ICD) and Cardiac Resynchronization with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, the patient will need alternative, longer-term therapy. ***Compared to the HeartMate II™ LVAD in the Therapy Defibrillator (CRT-D) devices are intended to provide and a left ventricular end systolic dimension (LVESD) 70 mm ≤ CentriMag™ Circulatory Support System Contraindications MOMENTUM 3 trial. ventricular antitachycardia pacing and ventricular cardioversion/ whose symptoms and MR severity persist despite maximally [PMA Approval; 30-day use]: The CentriMag™ Circulatory Support defibrillation. The CRT-D devices are also intended to resynchronize tolerated GDMT as determined by a multidisciplinary heart team 1. Kirklin J, Naftel D, Pagani F, et al. Seventh INTERMACS System is contraindicated for use as a cardiotomy suction device. the right and left ventricles. experienced in the evaluation and treatment of heart failure and annual report: 15,000 patients and counting. J Heart Lung The system is also contraindicated for patients who are unable or The myMerlinPulse™ mobile application is intended for use by people mitral valve disease. Transplant. 2015;34(12):1495-1504. unwilling to be treated with an appropriate anticoagulant such as who have an Abbott Medical implanted heart device and access to a MitraClip™ G4 System Contraindications: The MitraClip G4 System Heparin or a comparable alternative. 2. Saeed M, Hanna I, Robotis D, et al. Programming ICD in mobile device. The app provides remote monitoring capability of the is contraindicated in patients with the following conditions: Patients implanted heart device by transmitting information from the patient’s CentriMag™ Circulatory Support System Adverse Events [PMA patients with primary prevention indication to prolong time who cannot tolerate, including allergy or hypersensitivity to, procedural Adverse events that may be associated with implanted heart device to the patient’s healthcare provider. Approval; 30-day use]: to first shock PROVIDE study. J Cardiovasc Electrophysiol. anticoagulation or post procedural anti-platelet regime; Patients with mechanical circulatory support can include, but are not limited to, 2014. Gallant™ ICD and Gallant™ CRT-D Indications: The ICD known hypersensitivity to clip components (nickel / titanium, cobalt, the following: bleeding on device support, hemolysis, infection, and CDT-D devices are indicated for automated treatment of chromium, polyester), or with contrast sensitivity; Active endocarditis renal failure/dysfunction/complication, respiratory dysfunction, 3. Epstein, A. Benefits of the implantable cardioverter- life-threatening ventricular arrhythmias. CRT-D devices are also of the mitral valve; Rheumatic mitral valve disease; Evidence of hepatic dysfunction, cardia arrhythmias (atrial or ventricular), defibrillator. J Am Coll Card. 2008. indicated to treat symptoms in patients who have congestive heart intracardiac, inferior vena cava (IVC) or femoral venous thrombus. thromboembolism (venous and arterial non-CNS), hypotension, failure with ventricular dyssynchrony. 4. Varma N. Gain in CRT Efficacy with Dynamic Electrical MitraClip™ G4 System Potential Complications and Adverse hypertension, device malfunction or failure, psychiatric events, right Events: The following ANTICIPATED EVENTS have been identified heart failure, and death. Optimization: Real World Effect of SyncAV™ CRT on Heart In addition, dual chamber ICD and CRT-D devices with the AT/ as possible complications of the MitraClip G4 procedure: Allergic Failure Hospitalizations. Poster presented at: EHRA; May AF detection algorithm are indicated in patients with atrial Humanitarian Device Statement: Caution: Humanitarian Device. reactions or hypersensitivity to latex, contrast agent, anaesthesia, 2020. Accessed May 15, 2020. https://www.escardio.org/ tachyarrhythmias or those patients who are at significant risk of The CentriMag Circulatory Support System is authorized by developing atrial tachyarrhythmias. device materials (nickel / titanium, cobalt, chromium, polyester), Sub-specialty-communities/European-Heart-Rhythm- Federal Law for temporary circulatory support for up to 30 days for and drug reactions to anticoagulation, or antiplatelet drugs, patients in cardiogenic shock due to right ventricular failure. The EMPOWERING THE MR Conditional ICDs and CRT-Ds are conditionally safe for use Association-%28EHRA%29/Research-and-Publications/ Vascular access complications which may require transfusion in the MRI environment when used in a complete MR Conditional effectiveness of this device for this use has not been demonstrated. EHRA%20Essentials-4-You#lbt. or vessel repair including: wound dehiscence, catheter site system and according to instructions in the MRI-Ready Systems reactions, Bleeding (including ecchymosis, oozing, hematoma, CentriMag™ RVAS Indications [Humanitarian Exemption Device 5. Mack M. COAPT: Three-Year Outcomes from a Randomized manual. Scanning under different conditions may result in severe hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, (HDE) Approval; 30-day use]: The CentriMag Circulatory Support Trial of Transcatheter Mitral Valve Leaflet Approximation patient injury, death or device malfunction. pseudoaneurysm, aneurysm, dissection, perforation / rupture, System is intended to provide temporary circulatory support for in Patients with Heart Failure and Secondary Mitral The myMerlinPulse™ mobile application is indicated for use by vascular occlusion, Emboli (air thrombotic material, implant, device up to 30 days for patients in cardiogenic shock due to acute right Regurgitation. Presented at TCT 2019. TRANSFORMATION OF patients with supported Abbott Medical implanted heart devices. component); Peripheral Nerve Injury; Lymphatic complications; ventricular failure. Pericardial complications which may require additional intervention, 6. Abraham W, Adamson P, Bourge R, et al. Wireless Gallant™ ICD and Gallant™ CRT-D Contraindications: CentriMag™ RVAS Contraindications [Humanitarian Exemption including: Pericardial effuse on, Cardiac tamponade, Pericarditis; The CentriMag Circulatory pulmonary artery haemodynamic monitoring in chronic Contraindications for use of the pulse generator system include Device (HDE) Approval; 30-day use]: Cardiac complications which may require additional interventions Support System is contraindicated for use as a cardiotomy suction heart failure: a randomised controlled trial. The Lancet. ventricular tachyarrhythmias resulting from transient or correctable or emergency cardiac surgery, including: Cardiac perforation, Atrial device. The system is also contraindicated for patients who are 2011;377(9766):658-66. factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. septal defect; Mitral valve complications, which may complicate unable or unwilling to be treated with an appropriate anticoagulant or prevent later surgical repair, including: Chordal entanglement 7. Shavelle D, Desai A, Abraham W, et al. Lower rates of heart such as Heparin or a comparable alternative. The myMerlinPulse™ mobile application is contraindicated for use / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, HEART FAILURE
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