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 failure and all-cause hospitalizations during pulmonary CentriMag™ Acute Circulatory Support System Temporary with any implanted medical device other than supported Abbott Dislodgement of previously implanted devices, Tissue damage, artery pressure-guided therapy for ambulatory heart failure. Expanded Indication: The FDA issued an enforcement policy guidance Medical implanted heart devices. Mitral valve stenosis, Persistent or residual mitral regurgitation, Circulation: Heart Failure. Published online 2020. document in April 2020 allowing for FDA-cleared or approved Gallant™ ICD and Gallant™ CRT-D Adverse Events: Possible Endocarditis; Cardiac arrhythmias (including conduction disorders, cardiopulmonary bypass devices to be used in an ECMO circuit to treat https://doi.org/10.1161/CIRCHEARTFAILURE.119.006863. adverse events associated with the implantation of the pulse generator atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic patients who are experiencing acute respiratory failure and/or acute system include the following: Arrhythmia (for example, accelerated conditions (including myocardial infarction, myocardial ischemia, 8. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically cardiopulmonary failure during the COVID-19 public health emergency. or induced), Bradycardia, Cardiac or venous perforation, Cardiac and unstable / stable angina); Venous thromboembolism (including Levitated Ventricular Assist Device-Final Report. The CentriMag™ System including the CentriMag™ Blood Pump and tamponade, Cardiogenic shock, Death, Discomfort, Embolism, deep vein thrombosis, pulmonary embolism, post procedure N Engl J Med. 2019; 380:1618-1627. PediMag™ Blood Pump are indicated for use as part of an ECMO circuit Endocarditis, Erosion, Exacerbation of heart failure, Excessive pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and for longer than 6 hours to treat patients with acute respiratory failure fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, Transient Ischemic Attack (TIA); System organ failure: Cardio- 9. Khush K, Cherikh W, Chambers D, et al. The International and/or acute cardiopulmonary failure. respiratory arrest, Worsening heart failure, Pulmonary congestion, Thoracic Organ Transplant Registry of the International diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart Respiratory dysfunction / failure / atelectasis, Renal insufficiency CentriMag™ Blood Pump Indications [510(k) Clearance; 6-hour Society for Heart and Lung Transplantation: Thirty-fifth block, Hemorrhage, Hemothorax, Hypersensitivity, including local or failure, Shock (including cardiogenic and anaphylactic); Blood use]: The CentriMag Circulatory Support System is indicated Adult Heart Transplantation Report—2018; Focus Theme: tissue reaction or allergic reaction, Infection, Keloid formation, cell disorders (including coagulopathy, hemolysis, and Heparin to pump blood through the extracorporeal bypass circuit for Multiorgan Transplantation. J Heart Lung Transplant. Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial Induced Thrombocytopenia (HIT)); Hypotension / hypertension; extracorporeal circulatory support for periods appropriate to 2018;37(10):1155-1168. effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Infection including: Urinary Tract Infection (UTI), Pneumonia, cardiopulmonary bypass (up to six hours). It is also indicated for Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; use in extracorporeal support systems (for periods up to six hours) 10. Aziz T, Singh G, Popjes E, Stephenson, E., et al. Initial Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, experience with CentriMag extracorporeal membrane laceration of the subclavian artery, arteriovenous fistula, neural echocardiogram (TEE) and Transthoracic echocardiogram (TTE) circulatory support during mitral valve reoperation, surgery of the oxygenation for support of critically ill patients with damage, thoracic duct injury, cannulation of other vessels, massive -related complications: Skin injury or tissue changes due to exposure vena cava or aorta, liver transplants etc.). refractory cardiogenic shock. J Heart Lung Transplant. hemorrhage and rarely, death. Among the psychological effects of to ionizing radiation, Esophageal irritation; Esophageal perforation, CentriMag™ Blood Pump Contraindications [510(k) Clearance; 2010;29(1):66-71. device implantation are imagined pulsing, depression, dependency, Gastrointestinal bleeding. 6-hour use]: The CentriMag Circulatory Support System is 11. Bhama J, Kormos R, Toyoda Y, et al. Clinical experience fear of premature battery depletion, device malfunction, inappropriate CardioMEMS™ HF System Indications and Usage: The contraindicated for use as a cardiotomy suction device. The system pulsing, shocking while conscious, or losing pulse capability. Possible using the Levitronix CentriMag system for temporary right CardioMEMS™ HF System is indicated for wirelessly measuring is also contraindicated for patients who are unable or unwilling to adverse device effects include complications due to the following: ventricular mechanical circulatory support. J Heart Lung and monitoring pulmonary artery (PA) pressure and heart rate be treated with an appropriate anticoagulant such as Heparin or a Abnormal battery depletion, Conductor fracture, Device-programmer Transplant. 2009;8(9):971-976. in New York Heart Association (NYHA) Class III heart failure comparable alternative. communication failure, Elevated or rise in defibrillation/cardioversion patients who have been hospitalized for heart failure in the previous threshold, Inability to defibrillate or pace, Inability to interrogate PediMag™ Blood Pump Indications for Use [510(k) Clearance; 12. John R, Long J, Massey H, et al. Outcomes of a multicenter year. The hemodynamic data are used by physicians for heart The PediMag Blood Pump is indicated for use with the or program due to programmer or device malfunction, Incomplete 6-hour use]: trial of the Levitronix CentriMag ventricular assist system failure management and with the goal of reducing heart failure CentriMag Circulatory Support System console and motor to pump lead connection with pulse generator, Inhibited therapy including for short-term circulatory support. J Thorac Cardiovasc hospitalizations. blood through the extracorporeal bypass circuit for extracorporeal defibrillation and pacing, Inappropriate therapy (for example, Surg. 2011;141(4):932-939. circulatory support for periods appropriate to cardiopulmonary shocks and antitachycardia pacing [ATP] where applicable, pacing), CardioMEMS™ HF System Contraindications: The CardioMEMS bypass (up to six hours) for surgical procedures such as mitral Interruption of function due to electrical or magnetic interference, HF System is contraindicated for patients with an inability to take 13. Daubert J, Saxon L, Adamson P, et al. EHRA/HRS expert valve reoperation. It is also indicated for use in extracorporeal Intolerance to high rate pacing (for example dyspnea or discomfort), dual antiplatelet or anticoagulants for one month post implant. consensus statement on cardiac resynchronization therapy support systems (for periods up to six hours) not requiring complete Lead abrasion, Lead fracture, Lead insulation damage, Lead migration CardioMEMS™ HF System Potential Adverse Events: Potential in heart failure: implant and follow-up recommendations cardiopulmonary bypass (e.g. valvuloplasty, circulatory support or lead dislodgement, Loss of device functionality due to component adverse events associated with the implantation procedure include, and management. Euro Soc Card. 2012;14:1236-1286. during mitral valve reoperation, surgery of the vena cava or aorta, failure, Pulse generator migration, Rise in DFT threshold, Rise in but are not limited to the following: Infection, Arrhythmias, Bleeding, liver transplants etc.). 14. Mullens W, Grimm R, Verga T, et al. Insights from a pacing threshold and exit block, Shunting of energy from defibrillation Hematoma, Thrombus, Myocardial infarction, Transient ischemic cardiac clinic as part of a heart failure disease management paddles, System failure due to ionizing radiation. Additionally, attack, Stroke, Death and Device embolization. PediMag™ Blood Pump Contraindications [510(k) Clearance; potential adverse events associated with the implantation of a coronary 6-hour use]: The PediMag Blood Pump is contraindicated for use program. JACC. 2009;53(9):765-773. HeartMate 3™ LVAS Indications: The HeartMate 3™ Left venous lead system include the following: Allergic reaction to contrast as a cardiotomy suction device. The CentriMag Circulatory Support Ventricular Assist System is indicated for providing short- and long- media, Breakage or failure of implant instruments, Prolonged exposure System is contraindicated for use as a cardiotomy suction device. 15. Curtis A, Worley S, Adamson P, et al. Biventricular pacing term mechanical circulatory support (e.g., as bridge to transplant to fluoroscopic radiation, Renal failure from contrast media used The system is also contraindicated for patients who are unable or for atrioventricular block and systolic dysfunction or myocardial recovery, or destination therapy) in patients with to visualize coronary veins. Refer to the User’s Manual for detailed unwilling to be treated with an appropriate anticoagulant such as N Engl J Med. 2013;368:1585-93. advanced refractory left ventricular heart failure. intended use, indications, contraindications, warnings, precautions and Heparin or a comparable alternative. HeartMate 3™ LVAS Contraindications: The HeartMate 3™ Left 16. Stone G, Lindenfeld W, Abraham S, et al. Transcatheter potential adverse events. ™ Indicates a trademark of the Ventricular Assist System is contraindicated for patients who cannot mitral-valve repair in patients with heart failure. N Engl No potential adverse events have been identified with use of the Abbott group of companies. tolerate, or who are allergic to, anticoagulation therapy. J Med. 2018;379:2307-18. As presented at ACC Annual myMerlinPulse™ mobile application. ‡ Indicates a third party trademark, Meeting, New Orleans, LA, March 17, 2019. HeartMate 3™ LVAS Adverse Events: Adverse events that may be which is property of its respective MitraClip™ G4 System Indications for Use: associated with the use of the HeartMate 3™ Left Ventricular Assist owner. 17. Fang J, Ewald G, Allen L, et al. Advanced (Stage D) Heart • The MitraClip™ G4 System is indicated for the percutaneous reduction System are: death, bleeding, cardiac arrhythmia, localized infection, © 2020 Abbott. All Rights Reserved. Failure: A statement from the HFSA guidelines committee. of significant symptomatic mitral regurgitation (MR≥ 3+) due to right heart failure, respiratory failure, device malfunctions, driveline MAT-2009321 v1.0 | Item approved J Card Fail. 2015;21(6):519-534. primary abnormality of the mitral apparatus [degenerative MR] in infection, renal dysfunction, sepsis, stroke, other neurological event for U.S. use only. CLINICAL CONSIDERATIONS FOR ADVANCED HEART FAILURE SOLUTIONS*

AHA STAGE STAGE B STAGE C STAGE D

AS NEEDED ALONG NYHA CLASS CLASS I CLASS II CLASS III CLASS IIIB CLASS IV THE HEART FAILURE Consider where on the NYHA scale your patients have predominantly been in the last 30 days CARE PATHWAY INTERMACS‡ 7 6 5 4 3 2 1

REGISTRY ADVANCED Profile descriptions: 7. Living comfortably with limited activity 6. Walking wounded 5. Homebound 4. Frequent flyer 3. Dependent stability 2. Sliding on inotropes 1. Crash and burn HF PROFILES1 Adv. NYHA III symptoms Exertion limited Exertion intolerant Resting symptoms Stable but inotrope dependent Progressive decline on inotropic support Clinical and cardiogenic shock

• Prior MI • Wide QRS • Secondary MR ≥ Grade III • > 1 HF Hospitalization in • Advanced Refractory Left HF INDICATION ACUTE MECHANICAL 12 Months • Low Ejection Fraction • Low Ejection Fraction • LVEF ≥ 20% and ≤ 50% • Low Ejection Fraction CIRCULATORY SUPPORT • LVESD <=70mm

SOLUTIONS Implantable Cardioverter Cardiac Resynchronization Transcatheter PA Pressure Left Ventricular ALONG THE  Defibrillator Therapy Mitral Valve Remote Assist Device (ICD) (CRT) Repair Monitoring (LVAD) Therapy HF CONTINUUM

MitraClip™ Transcatheter HeartMate 3™ Left Ventricular Gallant™ ICD Gallant™ CRT-D CentriMag™ Acute Mitral Valve Repair Assist Device CardioMEMS™ HF System Circulatory Support System • Detect, diagnose and provide • Dynamically optimizes CRT pacing • Reduces significant symptomatic • Monitors PA pressures remotely,  • Provides mechanical tailored therapy for life-threatening as cardiac condition changes for mitral regurgitation allows for proactive intervention circulatory support • Temporary cardiopulmonary CLINICAL arrhythmias maximum QRS narrowing • 33% relative risk reduction • Quality of life improvements6 • Overall survival of 79% at or ventricular support — adult BENEFITS • Prolongs and improves survival2 • Multiple LV pacing pulses from in mortality5 2 years,8 approaching that or pediatric • 57% reduction in heart failure  a single quadripolar lead of transplantation**9 • > 10-year period produced a • 51% relative risk reduction hospitalization with benefits • Excellent hemocompatibility 20%–30% reduction in mortality3 • Features SyncAV™ CRT technology, in HF hospitalization5 seen across HFrEF and • Reduced rehospitalizations,  for gentle blood handling10,11 which has been shown to reduce HFpEF patients7 reversed heart failure symptoms  8 • Low rate of blood-related INTEGRATED heart failure hospitalizations by and improved quality of life*** adverse events12 22% at 2 years4 REMOTE  MONITORING Merlin.net™ Patient Care Network Merlin.net™ Patient Care Network Merlin.net™ Patient Care Network

CONSIDER CRT CONSIDER TRANSCATHETER CONSIDER PA PRESSURE CONSIDER LVAD17 13,15,17 • Decline in NYHA  MITRAL VALVE REPAIR MONITORING • Persistently high PA pressures TRIGGERS FOR 13,14 functional class • Symptomatic, moderate-to- • Persistent NYHA III • Non-responsive to diuretics or CONSIDERATION • Worsening ejection fraction13,14 severe or severe secondary mitral functional limitations neurohormonal agents OF ADVANCED regurgitation16 • QRS widening13,14 • Heart failure hospitalizations • 6 MWD < 300 m THERAPIES* • LVESD ≤ 70 mm16 in the previous 12 months • Increased RV pacing15 • Heart failure hospitalizations • EROA ≥ .3 cm2 16 • ECHO exam unchanged • ECHO exam unchanged

See Important Safety Information referenced within.