Frequently Asked Questions

LEARNING ABOUT THE CARDIOMEMS™ HF SYSTEM FREQUENTLY ASKED QUESTIONS

WHAT IS THE CARDIOMEMS HF SYSTEM? CAN A MAGNETIC RESONANCE IMAGING (MRI) The CardioMEMS™ HF System is the first and SCAN BE DONE WITH THE PA SENSOR? only FDA-approved heart failure monitor proven to Patients can have an MRI scan under certain significantly reduce heart failure hospital admissions conditions. Talk with the doctor ordering the MRI and improve quality of life.1 scan to ensure that he or she knows that you have a CardioMEMS PA Sensor. HOW DOES THE CARDIOMEMS HF SYSTEM HELP A HEART FAILURE PATIENT? WILL THE PA SENSOR INTERFERE WITH AN MRI, Changes in PA pressures are an early indicator of A PACEMAKER OR AN IMPLANTABLE worsening heart failure. This can occur even before CARDIOVERTER DEFIBRILLATOR (ICD)? the patient notices symptoms such as shortness of No, the PA sensor will not interfere with a pacemaker breath or weight gain. or an ICD, even when a reading is being taken. Patients can have an MRI scan under certain conditions. Talk The CardioMEMS HF System comes with an with the doctor ordering the MRI scan to ensure that electronics unit used at home to take daily he or she knows that you have a PA sensor. measurements of PA pressures. These PA pressure readings are sent wirelessly to a secure website CAN PATIENTS TRAVEL WITH THE CARDIOMEMS for the clinician to review. This allows the care team HF SYSTEM? to confidently adjust medications without a patient Yes, patients can travel with the CardioMEMS HF feeling symptoms or needing a hospital or clinic visit. System. The home electronics system can be packed in its carrying case and checked as luggage. The HOW IS THE CARDIOMEMS™ PA SENSOR PA sensor should not alert airport security when a IMPLANTED? patient passes through the security checkpoint. The CardioMEMS™ PA Sensor is inserted into the A travel letter is available to address any concerns PA during a right heart catheterization procedure. that may arise with TSA, when traveling with your The doctor will make a small incision and insert a home electronics system. device called a catheter into the femoral vein. Using a fluoroscope (a type of X-ray) to visually guide the IS THE PROCEDURE COVERED BY HEALTH placement of the device, the doctor will thread the INSURANCE OR MEDICARE? catheter through the body to the heart and into The procedure may be covered by health insurance the PA. Once the catheter is in the right position, or Medicare. When you speak to the medical center, the sensor is released into the artery, where it remains after they determine you are a candidate, they can permanently. Patients may feel some mild discomfort help explain your coverage options. at the access site during recovery, but should be able to return to normal activities soon after the procedure.

HOW LONG DOES THE CARDIOMEMS PA SENSOR LAST? The PA sensor does not need a battery or replaceable parts and is intended to last the lifetime of the patient. WHERE CAN A POTENTIAL PATIENT FIND OUT WHERE CAN ONE GO TO FIND OUT MORE WHAT IT IS LIKE FOR PEOPLE TO LIVE WITH INFORMATION ON HEART FAILURE? THE CARDIOMEMS™ HF SYSTEM FROM PEOPLE Visit www.StayAheadofHF.com for more WHO HAVE BEEN IMPLANTED? information on heart failure. Many patients have shared their stories about how the CardioMEMS™ HF System has impacted their lives. You can view these by visiting www.StayAheadofHF.com.

1. Abraham WT, Stevenson L, Bourge RC, Lindenfeld J, Bauman J, Adamson PB. Sustained efficacy of pulmonary artery pressure to guide to adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomized trial. The Lancet. 2016;387(10017):453-461. https://doi.org/10.1016/S0140-6736(15)00723-0.

Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 Abbott.com

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.

Indications and Usage: 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.