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PARTNERSHIP: MANAGING DISEASE TOGETHER TODAY’S CHALLENGE Improving patient outcomes while reducing costs without compromising quality Heart failure affects OVER HALF Heart failure costs 26 MILLION 108 BILLION $ people globally of heart failure costs are due to hospitalization3 annually 1 2 A PARTNERSHIP THAT PRODUCES RESULTS TODAY’S RESULTS We provide solutions that are grounded in clinical evidence and best practices LEAD TECHNOLOGY REMOTE MONITORING HF SYSTEM AORTIC VALVES CARDIOMEMS ™ TRIFECTA HF System 37 % REDUCTION in HF hospitalizations at 15 months4 QUADRIPOLAR ™ 180-day overall Lead Technology 2,197 Aortic Valve adopting a LOWER-GRADIENT VALVE provides a positive economic impact to the health care system MERLIN COST SAVINGS of $ ™ vs. bipolar CRT systems5 ™ Remote Monitoring PATIENT 91 COMPLIANCE % rate of with remote monitoring within 91 days post-implant6 A PLATFORM FOR PARTNERSHIP TODAY’S PARTNER We work with you to provide a comprehensive approach to disease management INNOVATIVE CONTRACT SOLUTIONS TREATMENT PATHWAY & OPERATIONAL EXCELLENCE DISEASE MANAGEMENT Managing COMPLEX patient populations HF AF Helping to REDUCE COSTS Building EFFICIENT operations and optimizing treatment CAD SEE THE IMPACT. A partnership with St. Jude Medical could help you reduce costs while improving patient outcomes. Request an economic analysis from our Healthcare Economics team at [email protected]. sjm.com 1. Lopez-Sendon, J. Heart failure: A paradigm shift. Medicographia. 2011;33(4):363-9. 2. International Journal of Cardiology. 2014 Feb 15;171(3):368-76. doi: 10.1016/j.ijcard.2013.12.028. Epub 2013 Dec 22. 3. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: A report of the ACC/AHA Task Force on Practice Guidelines. Circulation. 2013;128(16):1810-52. 4. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery hemodynamic monitoring in chronic heart failure: A randomized controlled trial. Lancet. 2011;377(9766):658-66. 5. Graham CM, et al. Comparison of Utilization and Hospital Costs for Quadripolar versus Bipolar LV Lead Technologies. HRS 2014. . May 7-10, 2014. 6. Ren X, et al. Remote Monitoring of Implantable Pacemakers: In-Office Setup Significantly Improves Successful Data Transmission. Clin. Cardiol. 36, 10, 634–637 (2013). Rx only. 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. CardioMEMS™ HF System Indications: 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. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. Merlin@home™ Transmitter Indications: 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. Trifecta™ Stented Tissue Valves Indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, perforation, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless contraindicated, is recommended for all patients with bioprosthetic valves. Long-term anticoagulant therapy, unless contraindicated, is recommended for all patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use. Quartet™ & Quadripolar Leads Indications: Indications: The Quartet lead has application as part of a St. Jude Medical biventricular system. Contraindications: The use of the Quartet lead is contraindicated in patients who: Are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate. Are unable to undergo an emergency thoracotomy procedure. Have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. Quadripolar Pacing Indications: St. Jude Medical™ ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT-Ds are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin® PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction. Adverse Events: Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to: component failure, device-programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionizing radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by: multiple counting of cardiac events including T waves, P waves, or supplemental pacemaker stimuli. Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing and fear of losing pulse capability. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2014 St. Jude Medical, Inc. All Rights Reserved. SJM-COR-1114-0032