CardioMEMS Model CM1100 Patient System Guide

Contents Introduction... 1 When is the CardioMEMS™ HF System used?... 1 What is the purpose of the CardioMEMS™ HF System?... 1

How your Heart Works... 2 Heart Failure... 2

Causes of Heart Failure... 2 Symptoms of Heart Failure... 3 Managing Your Heart Failure... 3

Precautions... 4 Warnings... 4 Clinical Study Information... 5 Introduction... 5 GUIDE-HF Trial - Randomized Arm... 5 Pivotal Data from the CHAMPION Trial... 6 Potential Risks within 30 days of the Implant Procedure... 6 Potential Risks within 6 months of the Implant Procedure... 6 Potential Risks within 1½ years of the Implant Procedure... 7 Long-term Data from the CardioMEMS US Post-Approval Study... 7

Sensor Implantation... 7

Before the Implant Procedure... 7 Implant Procedure... 8 After the Implant Procedure... 9

Taking a Home Reading... 9

Important Safety Information... 9 Patient Electronics System... 9 Setting Up the Patient Electronics... 10 Connectivity Method... 11 Steps for Taking a Reading... 13 Troubleshooting the Patient Electronics System... 15 Orientation Ball... 18 Additional Features... 18 Software Update... 19

Living with your CardioMEMS™ HF System... 19

When to Call Your Doctor... 19 Care of the Patient Electronics System... 20 Replacing your Patient Electronics System... 20 Setting Up a Replacement System... 20 Repacking... 22

Electromagnetic Interference and Electromagnetic Compatibility... 24 FCC Statement... 26 System Specifications... 26

Electrical Characteristics... 26 Mechanical Characteristics... 27

Environmental Information... 27 Classification... 27 Testing... 27 System Testing... Safety Testing... EMI/EMC Testing... Wireless Testing...

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Software... 27 Symbols... 27 WEEE Compliance Statement... 29 Replacement and Limited Warranty Summary... 29 Technical Support... 29

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Introduction You have been diagnosed with heart failure (HF). Heart failure results from damage to the heart that makes it difficult for the heart to pump enough blood to your body. Heart failure is a progressive disease that often gets worse over time. The most common causes of heart failure are high blood pressure and coronary artery disease, in which blood vessels that supply blood to the heart are narrowed or blocked. Approximately 5 million people in the United States suffer from heart failure. It is one of the most common reasons for hospitalizations in people over 70 years of age.

When is the CardioMEMS™ HF System used? Your doctor has determined that you might benefit from the information obtained by the CardioMEMS™ HF System because you have heart failure and are at an increased risk of hospitalization.

What is the purpose of the CardioMEMS™ HF System? The CardioMEMS HF System uses an implanted sensor to monitor the pressure in your pulmonary artery (PA). Your doctor can use pulmonary artery pressures to make informed decisions about your heart failure treatment, including whether to change critical medications. You will take a sensor reading each day from home using the Patient Electronics System, which sends the information to your doctor. After analyzing the information, your doctor may contact you to make medication changes to help treat your heart failure. This guide will tell you how the system operates. It will discuss what to expect during and after the implant of the device. This guide will explain how to setup the Patient Electronics System in your home and how to take a daily reading. It will talk about some of the changes that may occur in your life and answer many of the more common questions. If you have questions about what you read in this guide, discuss them with your doctor or nurse. They are your best resources for information. The CardioMEMS™ HF System includes the following components: Figure 1. Pulmonary Artery (PA) Sensor (Sensor)

Figure 2. Patient Electronics System

Patient Electronics System The Patient Electronics System (System) consists of the electronics unit and receiving antenna (embedded in the pillow) and the Controller. Together, the components of the System read your PA pressure measurements from your sensor wirelessly and then transmit the information to your physician. The antenna is paddle-shaped and is pre-assembled inside the pillow to make it easier and more comfortable for you to take readings. Figure 3. The Controller

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Figure 4. The Pillow

How your Heart Works Your heart is a muscle that pumps blood throughout your body. It has four chambers. The upper chambers are called atria (left and right) and the lower chambers are called ventricles (left and right). The right side of the heart receives “used” blood coming back from the body and pumps the blood to the lungs, where it picks up oxygen. Blood then returns to the left side of the heart, which in turn pumps the blood to the rest of the body. Figure 5. Normal Heart 1. Right atrium 2. Right ventricle 3. Left atrium 4. Left ventricle

Heart Failure Heart failure is a serious illness. It means that your heart cannot squeeze hard enough to move enough blood out to your body, or that your heart muscle is too thick and does not relax enough between beats to allow it to fill with blood. Heart failure can make you feel tired or weak and can also cause swelling and fluid buildup in your legs, feet, stomach, and even your lungs. Fluid buildup in your lungs is often referred to as “congestion,” which is why heart failure is sometimes called “congestive heart failure.”

Causes of Heart Failure Anything that weakens the heart muscle so it does not pump blood normally can cause heart failure. Some of the common causes of heart failure include: ▪ Coronary Artery Disease. Blocked arteries can trigger heart attacks that cause heart muscle cells to die. The muscle is weakened and pumps less efficiently. ▪ Untreated High Blood Pressure. High blood pressure forces the heart to pump harder to move blood through the body. That can cause the heart to weaken over time. ▪ Faulty Heart Valves. Heart valves that do not work properly (either because they are leaky or because they do not open wide enough) can cause the heart muscle to weaken. ▪ Cardiomyopathy (Heart Muscle Disease). The heart muscle becomes enlarged or weakened for unknown reasons. Over time, the heart muscle weakens and the heart becomes enlarged, as shown below. The ventricles are unable to contract with the same strength as before. As a result, the flow of blood and oxygen to the body is poor. Figure 6. A normal heart 1. Left ventricle

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Figure 7. An enlarged heart 1. Left ventricle

Symptoms of Heart Failure It is important to tend to your symptoms as soon as they begin. Like many people, you may fail to notice symptoms in their early stages, or you may shrug them off. Ignoring symptoms is risky. Symptoms such as trouble breathing or swollen ankles can mean that your heart failure is getting worse. Worsening symptoms can quickly lead to urgent problems that require a hospital stay. Some of the most common symptoms that patients with heart failure experience include: ▪ Fatigue, loss of energy You may find that you get very tired from very little effort, like walking up the stairs or doing your daily chores. ▪ Shortness of breath Shortness of breath is often described as “not getting enough air.” You may become more short of breath with exertion. You may awaken abruptly at night with a sensation of shortness of breath or feel the need to sit up to sleep. You may also experience a frequent, dry cough that is often made worse when you lie down in bed. ▪ Weight gain Weight gain over several days in a row is a common sign that there is fluid buildup in the body. You may experience a weight gain of 3 pounds or more before you notice any swelling or shortness of breath. ▪ Swelling You may notice swelling of your feet, legs or abdomen. This is usually worse later in the day and in the lowest part of your body. Swelling occurs because the extra fluid seeps into the tissues from the small blood vessels. You may notice that your shoes, socks or pants are fitting more tightly at the end of the day. ▪ Loss of Appetite or Bloating Sensation Many people with heart failure notice retention of fluid in the abdomen. When this happens, you may experience a distended or bloated sensation. You may also experience loss of appetite or even an upset stomach. Medicines may not be absorbed as well and therefore will not work as effectively. ▪ Decreased Urination during the Day, Increased Urination at Night The heart works harder during the day than at night, when you are at rest. This leads to less urine production during the day. When you are sleeping, the work of the heart is lessened, which allows the kidneys to make more urine. The pressure in the vessels around your heart changes before you feel any of these symptoms. Such changes can be detected by the CardioMEMS HF System sensor. Your doctor may change some of your medications based on the information obtained from the sensor. It is important to follow all directions your physician gives you, even if you are not feeling bad.

Managing Your Heart Failure Good management of your heart failure will lessen the impact of the symptoms on your daily life. Your doctor will determine and discuss the best treatment options with you. Making changes in your food selections and daily activities, taking pressure readings, and taking the medications that your doctor prescribes can make a major difference in how you feel.

Medications Medicines are important in the treatment of heart failure. Many research studies have shown that heart failure medicines can help stabilize your heart function and can help you: ▪ Live longer ▪ Have fewer symptoms ▪ Increase activity level ▪ Have more energy ▪ Have less swelling ▪ Breathe more easily ▪ Stay out of the hospital The major classes of medications used in the treatment of heart failure are: ▪ Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors). ACE inhibitors are very beneficial for people with heart failure. Research studies have shown that ACE Inhibitors help people live longer and decrease hospitalizations. They block the effects of harmful stress hormones (substances produced by your body that make heart failure worse). They help to relax blood vessels and lower blood pressure, which make it easier for the heart to pump blood out to the body. ▪ Angiotensin-Receptor Blockers (ARB). ARBs are similar to the ACE Inhibitors and are most commonly used when patients cannot take ACE inhibitors because of the side effects. Research studies have shown that ARB's also help people live longer ▪ Beta Blockers. Beta-blockers reduce the damaging effects of the hormone adrenalin on the heart and help you live longer. They also lower blood pressure and heart rate. ▪ Diuretics ("water pill"). Diuretics help your body get rid of extra fluid. Less fluid in your lungs makes breathing easier. Less fluid also means less swelling in other parts of your body. Having less fluid in your body will help you feel more comfortable. ▪ Aldosterone Antagonist. Aldosterone antagonists block the effects of a stress hormone called aldosterone, which can make heart failure worse. Research has shown that aldosterone antagonists help people live longer. ▪ Vasodilator and Nitrate Combination. Vasodilators relax the arteries, which reduces the heart’s workload. Nitrates reduce the amount of oxygen the heart needs and improves blood flow to the heart. Research has shown that these medicines also help people live longer. 3

Daily Pulmonary Artery Pressure Reading The pressures in the vessels around your heart change before you notice any weight gain or swelling. Taking daily pressure readings with the Patient Electronics System allows your doctor to treat you before these symptoms occur and to manage your heart failure more effectively.

Daily Weights Your doctor may have instructed you to weigh yourself every morning using the same scale. Weighing yourself every day will help you notice any extra fluid buildup. If you ignore the weight gain, the fluid will find its way to your lungs, abdomen, legs, and feet. By the time you see swelling in your ankles, you may have already retained an extra five to seven pounds of fluid.

Low Sodium Diet Table salt is composed of sodium and chlorine. It is important to decrease the amount of sodium you eat because heart failure causes your body to hold on to extra sodium. The sodium causes extra fluid to build up. That leads to symptoms such as swelling of the ankles, feet or abdomen, shortness of breath, or weight gain. By reducing the amount of sodium in your diet, you will retain less fluid and reduce many of the symptoms of heart failure. You cannot eliminate sodium entirely because it is present in most foods, but any reduction in the amount of sodium you eat will have big benefits for you. It may take some time to adjust to a low-sodium diet, but it is worth the effort. A low-sodium diet can help you feel better and allow your heart failure medicines to work more efficiently.

Fluid Control Many people with heart failure take diuretics to remove excess fluid. However, the action of these medications can be overwhelmed if you drink too much fluid. Patients with more advanced cases of heart failure are often advised to limit their total daily fluid intake to two quarts a day. The guidelines for sodium and fluid intake may vary depending on the severity of your heart failure and should be discussed with your physician.

Alcohol Alcohol has a direct effect on the heart by decreasing the strength of the contraction. With a muscle that is already weak, as in heart failure, this is not a good idea. You should limit alcohol to one drink or less per day or avoid alcohol completely.

Tobacco Cessation Tobacco products (not just cigarettes) contain nicotine. Nicotine causes blood vessels to become narrower. This raises the blood pressure and pulse rate, making more work for your weakened heart. You should avoid exposure to all tobacco products, including secondhand smoke.

Activity and Exercise Your heart is a muscle. It needs exercise, just like all the other muscles in your body. Activity can help you feel better, may decrease your symptoms, and may improve your heart’s function. Ask your doctor or nurse about an exercise or walking program to help build your tolerance for activity.

Precautions Failure to follow these precautions may result in system malfunction, damage to the system, or delay in information getting to your doctor. ▪ Do not place the electronics unit near an open window. Exposing the unit to rain, water, moisture or direct sunlight may severely damage it. ▪ Do not apply excessive pressure to the display screen. Excessive pressure may damage the display. ▪ Do not apply excessive or damaging force to any part of the electronics unit. ▪ Do not expose the electronics to excessive vibration, impact, or rough handling. ▪ Allow the cover to air dry after washing it (hand wash or machine gentle cycle.) Do not place the cover in a clothes dryer. ▪ To avoid potential damage caused by lightning, unplug the electronics unit during electrical storms. ▪ Allow the electronics unit to shut-down automatically. Failure to do so may corrupt the files. ▪ The electronics unit should not be used adjacent to or stacked with other equipment. If it is necessary to operate it adjacent to or stacked with other equipment, verify that the electronics unit is operating normally in the configuration in which it will be used. ▪ Exposure to excess lint, dust, or corrosive materials may result in a malfunction. ▪ If your electronics unit uses a telephone line communication, be aware that other equipment may interrupt the communication. Contact Technical Support, if you have questions about such equipment. ▪ Your Patient Electronics System communicates securely through the internet to transmit your reading. Portions of this internet pathway may become unavailable for periods of time for a variety of reasons including but not limited to: internet connectivity outage, hardware failure, power outage, or general infrastructure failures. Readings that are unable to transmit are stored and will transmit when internet connectivity is available. ▪ Contact your physician if you are unable to send or use readings for three or more days. ▪ The accuracy of the system may be affected by various factors. If your physician suspects that the sensor pressure readings may not be accurate, the use of the pressure information may be temporarily suspended. Recalibration of the sensor may be necessary to continue use of the system. Recalibration of the sensor may require the performance of a right heart catheterization procedure. ▪ The touchscreen display on the handheld unit can be sensitive to electrostatic discharge (ESD) at high levels. To reduce the potential for ESD discharge to the touchscreen, remove and hold the plastic handle of the handheld prior to contact with the touchscreen. If the touchscreen becomes damaged due to ESD, the screen will be discolored or may be unresponsive. Contact Technical Support for replacement of the Controller. Please note that high levels of ESD are more likely in situations where the relative humidity is very low, such as inside a heated building during the winter in areas where it is cold outside. In order to reduce the potential for high levels of ESD, there are common situations which create static electricity that can be avoided prior to use, for example, putting on and removing clothes, dragging your feet across a carpet or rug, vacuuming, or removing clothes from a dryer.

▪ Once the reading has been successfully performed, always return the Controller to the cradle which is located on the rear of the electronics unit. ▪ The system is not intended to be used in a severe electromagnetic radiation environment or an industrial environment. ▪ The system should not be used in conjunction or in association with Magnetic Resonance Imaging (MRI), computerized axial tomography (CT), diathermy, Radio Frequency Identification (RFID), and electromagnetic security systems such as metal detectors.

▪ The patient is an intended operator.

Warnings Failure to follow these warnings may result in damage to the system, system malfunction, delay in information getting to your doctor, inaccurate readings, or injury. ▪ Only authorized personnel should use the Patient Electronics System. ▪ Do not remove the cover or attempt to service the electronics unit. Service should be performed by an authorized technician. 4

▪ If any of the following occurs, immediately unplug the electronics unit and call Technical Support: – Any cords are noticeably frayed or damaged. – Liquid has been spilled onto the electronics unit, or it has been exposed to rain. – The electronics unit has been dropped or damaged. – If you lose the power cord, you must replace it with an identical power cord. Contact Technical Support. ▪ Medical Electrical Equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided. If interference is noted, remove or stop using the interfering equipment. ▪ Portable and mobile RF communications equipment can affect medical electrical equipment and may cause a malfunction of the system. ▪ Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the system including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. ▪ Use only cables and accessories provided. The use of other attachable parts other than the parts provided may result in inaccurate readings, damage to the electronics, or injury to the user. ▪ Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The use of other attachable parts other than the parts provided may result in inaccurate readings, damage to the system, or injury to the user. ▪ Other equipment may interfere with the electronics unit operation, even if the other equipment complies with CISPR emission requirements. See the Electromagnetic Interference and Electromagnetic Compatibility section for guidance. ▪ Two Patient Electronics Systems may interfere with each other. Only operate one electronics unit at a time in the same general vicinity. ▪ If two electronic units are proximate to each other and are used at the same time, pressure measurements may be affected due to interference between the two systems. In such isolated cases, it is recommended that operation of each electronics unit occur at separate times. ▪ While in use, ensure that the power supply is easily accessible since unplugging the electronics unit from the outlets is the only means of completely isolating from mains. ▪ Do not attempt to connect the electronics unit to any network or data coupling equipment in your home other than specified in the instructions for use. ▪ If redness of the skin develops or a change in skin sensitivity occurs, discontinue use of this product immediately and contact your physician. ▪ Keep the Patient Electronics System away from pets and children. Ingestion of any part may cause injury. ▪ Care should be taken to keep all cables away from the neck and face to prevent airway blockage. ▪ Do not attempt to connect the electronics unit or handheld unit to any other electronic equipment. ▪ Your Patient Electronics System has been calibrated to work with your sensor. Use of different electronics unit may result in inaccurate information. ▪ Do not change the computer configuration without authorization. Changes to the configuration may result in inaccurate information. ▪ Use only manufacturer supplied Wi‑Fi‡ adapters.

▪ This device contains nitinol, an alloy of nickel and titanium. Persons who are allergic to nickel may have an allergic reaction to this device.

Clinical Study Information Introduction Heart failure is a life-threatening condition with debilitating symptoms and is a burden to patients and their care-givers. Over 60 million people are estimated to be living with heart failure world-wide. It has been shown that pulmonary artery (PA) pressures begin to increase earlier than signs and symptoms (for example, weight gain or shortness of breath) of worsening heart failure and can provide a physiologic basis for heart failure patient management. The CardioMEMS HF System provides a proven method for measuring PA pressure using a wireless pressure sensor implanted into the pulmonary artery. The CardioMEMS HF System provides clinicians with a patient’s PA pressure while the patient is at home, without the need for a procedure or office visit. This information allows the physician to manage the patient’s heart failure proactively with the goal of controlling PA pressures and reducing heart failure hospitalizations.

GUIDE-HF Trial - Randomized Arm Purpose The goal of the GUIDE‑HF trial (Hemodynamic-GUIDEd Management of Heart Failure) was to determine whether an expanded patient population would benefit from using PA pressure‑guided heart failure management: the CardioMEMS™ HF System.

Study Design The GUIDE‑HF trial (Randomized Arm) was conducted at 118 study sites (114 U.S. sites and 4 sites in Canada) and enrolled 1022 patients with NYHA Class II, III, or IV heart failure and either a prior heart failure hospitalization within 12 months or elevated natriuretic peptides (hormones that increase when the heart is not pumping properly). A total of 1000 Patients were randomized (assigned by chance) to one of two groups: the Treatment Group (standard of care plus using the CardioMEMS HF System) or the Control Group (standard of care only). All patients were implanted with the CardioMEMS PA Sensor and took daily readings from home, but clinicians only had access to pulmonary artery pressure information for patients in the Treatment Group.

Results The study was evaluated for success based on the total of heart failure hospitalizations, urgent heart failure visits (emergency department or hospital outpatient visits for intravenous diuretic therapy), and all‑cause mortality at 12 months. The study would be considered successful by demonstrating that the hemodynamic‑guided heart failure treatment is superior to the control therapy for heart failure outcomes. Overall, the Treatment group had 12% fewer primary endpoint events than the Control group, but the difference between groups was not significant. The difference between groups was primarily due to the Treatment group having 17% fewer heart failure hospitalizations compared to the Control group. However, the timing of the study overlapped with the COVID‑19 pandemic. To account for the impact of the COVID‑19 pandemic, the primary endpoint of the GUIDE-HF trial was also evaluated using follow-up data collected prior to the U.S. national emergency declaration date (March 13, 2020). Prior to COVID‑19, the Treatment group had 19% fewer primary endpoint events than the Control group, driven by a 27% reduction in risk for heart failure hospitalizations. The GUIDE‑HF trial primary endpoint was also evaluated in subgroups of patients. For NYHA Class, the clinical data demonstrated a treatment effect in NYHA Class II and III heart failure patients, with benefits remaining unclear in NYHA Class IV patients. Prior to COVID‑19, NYHA Class II/III patients in the Treatment Group experienced a 24% reduction in primary endpoint events compared with the Control Group. A treatment effect was also observed regardless of whether patients qualified for the study due to a heart failure hospitalization in the prior 12 months or as a result of elevated natriuretic peptides. A greater benefit was observed in women compared to men and in African American subjects compared to Caucasian patients. The subgroup analyses according to other factors (ejection fraction, age, sex, race, ethnicity, ischemic cardiomyopathy, and prior cardiac device implant) showed consistent benefit of the CardioMEMS HF System for patients regardless of these factors. 5

Of the 1022 patients enrolled in the study, 99.2% were free from a device or system-related complication. Potential Risks observed in the GUIDE‑HF trial were consistent with those in the CHAMPION clinical trial. In summary, despite the limitations of the COVID‑19 pandemic occurring during the follow‑up of the study, the results of the GUIDE‑HF Randomized Arm support the continued safety and effectiveness of the CardioMEMS HF System within an expanded population, as shown by reduced heart failure hospitalizations. The treatment benefit observed in NYHA Class II subjects and those with elevated natriuretic peptides but without a recent hospitalization for heart failure suggest that intervention in NYHA Class II heart failure, even before a heart failure hospitalization occurs, can provide benefit.

Pivotal Data from the CHAMPION Trial Purpose The goal of the CHAMPION trial (CardioMEMS Heart Sensor Allows Monitoring of Pressures to Improve Outcomes in NYHA Functional Class III Heart Failure Patients) was to determine if physicians could reduce heart failure hospitalizations by managing patient pulmonary artery pressures using the CardioMEMS HF System.

Study Design The CHAMPION trial was conducted at 64 study sites in the U.S. and enrolled 550 patients with New York Heart Association (NYHA) Class III heart failure who had been hospitalized for heart failure in the previous year. All patients were implanted with a sensor and then randomized (assigned by chance) to either the Treatment group (heart failure management on the basis of pulmonary artery pressure and standard of care) or the Control group (heart failure management on the basis of standard of care).

Results CHAMPION met its two primary safety endpoints with 1.4% of patients experiencing a device-related complication and no patients experiencing a sensor failure. The CHAMPION trial was not designed to assess the benefit of this treatment strategy by gender. Since most of the patients who participated in the trial were men, it was not possible to determine the effect of the device in women. The CHAMPION trial met its primary efficacy endpoint of reduction in the rate of heart failure hospitalizations with Treatment group patients having 28% fewer heart failure hospitalizations compared to Control group patients at 6 months. Men and women in the Treatment group had similar heart failure hospitalization rates. The CHAMPION trial also met its secondary efficacy endpoints with Treatment group patients having lower pulmonary artery pressures, fewer days in the hospital, and better quality of life compared to Control group patients. Over the entire randomized follow-up in the trial of 1½ years, Treatment group patients had 33% fewer heart failure hospitalizations compared to Control group patients. For every 100 patients treated, 23 heart failure hospitalizations were prevented per year. After the completion of the randomized portion of the trial, physicians managed all patients (former Treatment and Control groups) on the basis of pulmonary artery pressure and standard of care. When both groups were managed in the same fashion, their heart failure hospitalization rates were similar.

Potential Risks within 30 days of the Implant Procedure The following table is a summary of the minor and major clinical risks observed within 30 days of the implant procedure. Table 1. Clinical risks within 30 days Risks

Treatment Group

Control Group (Standard Therapy)

Death

0 out of 100 patients

1 out of 100 patients

Stroke

0 out of 100 patients

0 out of 100 patients

Myocardial Infarction (heart attack) or Chest Pain

2 out of 100 patients

3 out of 100 patients

Bleeding

3 out of 100 patients

3 out of 100 patients

Hematoma (bruising at catheterization site)

1 out of 100 patients

1 out of 100 patients

Thrombus (blood clot)

0 out of 100 patients

0 out of 100 patients

Arrhythmias (abnormal heart rhythm)

5 out of 100 patients

3 out of 100 patients

Kidney Dysfunction/Failure

2 out of 100 patients

2 out of 100 patients

Infection

5 out of 100 patients

4 out of 100 patients

Hypotension (low blood pressure)

3 out of 100 patients

2 out of 100 patients

Dehydration

0 out of 100 patients

0 out of 100 patients

Device Embolization (device movement)

0 out of 100 patients

0 out of 100 patients

Potential Risks within 6 months of the Implant Procedure The following table is a summary of the major clinical risks observed within 6 months of the implant procedure. Table 2. Clinical risks within 6 months Risks

Treatment Group

Control Group (Standard Therapy)

Death

5 out of 100 patients

7 out of 100 patients

Stroke

0 out of 100 patients

1 out of 100 patients

Myocardial Infarction (heart attack) or Chest Pain

5 out of 100 patients

6 out of 100 patients

Bleeding

1 out of 100 patients

1 out of 100 patients

Thrombosis (blood clot)

1 out of 100 patients

0 out of 100 patients

Ventricular Arrhythmia (abnormal rhythm of the lower chambers of the heart)

2 out of 100 patients

3 out of 100 patients

Kidney Dysfunction/Failure

5 out of 100 patients

3 out of 100 patients

Pulmonary Infections

3 out of 100 patients

4 out of 100 patients

Hypotension (low blood pressure)

3 out of 100 patients

3 out of 100 patients

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Table 2. Clinical risks within 6 months Risks

Treatment Group

Control Group (Standard Therapy)

Dehydration

1 out of 100 patients

0 out of 100 patients

Device Embolization (device movement)

0 out of 100 patients

0 out of 100 patients

Potential Risks within 1½ years of the Implant Procedure The following table is a summary of the major clinical risks observed within 1½ years of the implant procedure. Table 3. Clinical risks within 1½ years Risks

Treatment Group

Control Group (Standard Therapy)

Death

18 out of 100 patients

22 out of 100 patients

Stroke

2 out of 100 patients

2 out of 100 patients

Myocardial Infarction (heart attack) or Chest Pain

14 out of 100 patients

11 out of 100 patients

Bleeding

2 out of 100 patients

3 out of 100 patients

Thrombosis (blood clot)

2 out of 100 patients

0 out of 100 patients

Ventricular Arrhythmia (abnormal rhythm of the lower chambers of the heart)

7 out of 100 patients

8 out of 100 patients

Kidney Dysfunction/Failure

10 out of 100 patients

6 out of 100 patients

Pulmonary Infections

5 out of 100 patients

9 out of 100 patients

Hypotension (low blood pressure)

5 out of 100 patients

5 out of 100 patients

Dehydration

2 out of 100 patients

1 out of 100 patients

Device Embolization (device movement)

0 out of 100 patients

0 out of 100 patients

Long-term Data from the CardioMEMS US Post-Approval Study Purpose The purpose of the CardioMEMS US Post-Approval Study (PAS) was to show that the CardioMEMS HF System could be used safely and effectively to reduce heart failure hospitalizations in patients with NYHA Class III heart failure who experienced a heart failure hospitalization in the previous year.

Study Design A total of 1200 subjects were enrolled at 104 study sites in the United States. All patients enrolled in the PAS were implanted with a CardioMEMS sensor and had their heart failure managed using pulmonary pressures in addition to standard of care. Patients were followed for two years after sensor implant.

Results The PAS met both of its pre-specified safety endpoints with 0.4% of patients (5 out of 1214 patients who had an attempted implant) experiencing a devicerelated complication and one patient (out of 1200 patients with implanted sensors) experiencing a sensor failure (0.1% of study population). The PAS also met its pre-specified primary effectiveness endpoint of reducing the rate of heart failure hospitalizations and showed that patients had 57% fewer heart failure hospitalizations at 1 year compared to the year prior to sensor implant. As noted in the previous section, the CHAMPION trial was not designed to assess the benefit of using the CardioMEMS sensor by gender. Because of this, the PAS had a requirement to enroll at least 35% women and a pre-specified analysis of heart failure hospitalizations for both women and men. The goal to enroll at least 35% women was met and approximately 38% of patients enrolled in the PAS were women. Analysis of heart failure hospitalizations showed that women have a similar response to the use of CardioMEMS as men. In summary, the CardioMEMS US PAS has demonstrated that the CardioMEMS HF System is safe (99.6% freedom from device-related complications and 99.9 % freedom from sensor failure at 2 years) and effective (57% reduction in heart failure hospitalizations at one year), thus demonstrating the long-term safety and efficacy of the CardioMEMS HF system.

Sensor Implantation Before the Implant Procedure The CardioMEMS™ HF System technology provides physicians with reliable, accurate trends of pulmonary artery pressure measurements. This technology proved to be extremely valuable in the management of care for heart failure patients. The CardioMEMS HF System provides a method to measure pulmonary artery pressure by using a wireless sensor implanted into the pulmonary artery (a vessel close to your heart). Once inserted, the System can provide this valuable information to your doctor as often as desired. This can be performed in the physician’s office, clinic, or hospital. You will also be able to take pulmonary artery pressure measurements yourself at home. These home pressure measurements are then sent to a secure website. Your doctor can access the secure website to view your measurements allowing him/her to make earlier interventions (usually changes in medications) to manage your heart failure remotely. Prior to the implant procedure, your doctor will discuss with you the benefits and risk associated with receiving the CardioMEMS HF System. You will be given detailed instructions about the implant procedure and any questions you may have will be answered. As with any medical procedure, there are risks associated with the implantation of a sensor, although complications do not happen very often. You should talk with your doctor about these risks before undergoing the medical procedure. Some of these risks include but are not limited to: ▪ Air embolism ▪ Allergic reaction due to device component materials or procedure-related ▪ Infection – Upper respiratory infection – Bronchitis – Pneumonia – Acute Bronchitis – Groin abscess – Methicillin-resistant staphylococcal aureus infection 7

– Pulmonary Infiltration – Sepsis ▪ Arrhythmias – Ventricular tachycardia – Atrial fibrillation – Ventricular arrhythmia – Ventricular fibrillation – Atrial fibrillation with rapid ventricular response – Atrial flutter – Cardiac dysrhythmias – Tachycardia – Wide complex tachycardia – Atrial dysrhythmia ▪ Bleeding – Epistaxis/Nose bleeds – GI bleed – Bleeding - Other – Blood in stool – Catheter site bleeding – Catheter site ecchymosis – Hematuria ▪ Hemoptysis ▪ Hematoma (Bruising) – Hematoma – Catheter site hematoma – Vessel puncture site hematoma ▪ Nausea ▪ Cerebrovascular accident – Stroke/Transient ischemic attack ▪ Delayed wound healing ▪ Thrombus – Arterial thrombosis (limbs) – Blood clot ▪ Cardiovascular injury – Valve damage – Pseudoaneurysm formation – AV fistula – Pulmonary artery injury ▪ Myocardial infarction (Heart attack) ▪ Death ▪ Embolism – Pulmonary infarct – Pulmonary embolism – Device embolization ▪ Thermal burn ▪ Cardiac perforation ▪ Pneumothorax, thoracic duct injury, or hemothorax Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of this system.

Implant Procedure PA Sensor The PA Sensor is permanently placed in the pulmonary artery (the blood vessel that moves blood from your heart to your lungs) during a right heart catheterization procedure. The PA Sensor is about the size of small paper clip and has a thin, curved wire at each end. This sensor does not require any batteries or wires. It sends its pressure measurements to the Patient Electronics System. Figure 8. PA Sensor

Implant Procedure The steps of the implant procedure are: 1. You may receive a mild sedative before and/or during the procedure, but you will be awake so you can follow instructions. 2. A nurse will clean an area on your neck or groin and a local anesthetic (numbing) medicine will be injected at that site. 3. An electrocardiogram (EKG) will constantly monitor your heart rate and rhythm. 4. The doctor will make a small incision. 8

5. He or she will thread a device called a pulmonary artery catheter into your femoral or internal jugular vein. Using a fluoroscope (a type of x-ray), he or she will thread the PA catheter through your body to your heart and into your pulmonary artery. 6. Once the catheter is in the pulmonary artery, a small amount of contrast material (dye) is injected and pictures are taken to make sure the catheter is in the right position and to make sure the branch of the pulmonary artery is the appropriate size. This procedure is called angiography. 7. Next, the pulmonary artery catheter is removed and a delivery catheter with the PA Sensor attached is carefully threaded to your pulmonary artery over a guide wire (a very small wire used to guide catheters). The PA Sensor is then positioned in the pulmonary artery and released from the delivery catheter. 8. The delivery catheter will be removed and the pulmonary artery catheter positioned next to the Sensor. Once the PA Sensor is confirmed by x-ray to be in the correct position, it will stay inside the pulmonary artery permanently. 9. The doctor will hold a monitor (called an antenna) to your back, chest or side to obtain the Sensor’s signal. Pulmonary artery pressure readings will be recorded from both the Sensor and the pulmonary artery catheter. 10. The pulmonary artery catheter is removed and the Sensor will remain in your pulmonary artery (see figure below). Typically, the procedure may last up to one hour. If the doctor cannot safely pass the catheter into the pulmonary artery or if the pulmonary artery is not the appropriate size, you will not be able to receive the sensor. Figure 9. Location of the Sensor Implant 1. Implant location in Pulmonary Artery

After the Implant Procedure After the procedure is completed, you may be asked to lie flat on your back for a few hours to prevent any bleeding from the catheter insertion site. You may feel some discomfort at the site as you recover. You should be able to return to normal activities soon after the procedure. Your PA Sensor is permanently implanted. You will not feel it, and it will not interfere with your daily activities. The sensor will not interfere with other devices you may have such as a pacemaker, defibrillator, etc. As you recover from your implant procedure, it is important that you follow your doctor’s instructions, including: ▪ Report any redness, swelling, or drainage from the insertion site ▪ Walk, exercise, and bathe according to your doctor’s instructions ▪ Contact your doctor if you develop a fever that does not go away in two or three days ▪ Ask your doctor any questions you may have about your device, heart failure, or medication Before you go home, you will receive training about how to set-up and take readings with your Patient Electronics System. For your convenience, the steps for taking a reading are also provided in an easy to use Quick Start Guide. Your doctor or nurse will complete a temporary Patient Implant Identification Card before you go home from the hospital. A permanent card will be mailed to you within a few weeks. This card provides information about the sensor to health care professionals so that the sensor can be identified correctly if you need a chest x-ray, CT scan, MRI or other testing. It contains your name, your doctor’s name, and the serial numbers of your device. Always carry your Patient Implant Identification Card with you. It will alert medical and security personnel that you have an implanted device.

Taking a Home Reading You will take readings using the Patient Electronics System (electronics) as instructed by your physician. To experience the most benefit from the CardioMEMS™ HF System, it is important that you take readings daily or as instructed by your physician. Taking readings should become part of your daily routine. It should only take about 2-3 minutes. If you are having trouble taking a reading, contact Technical Support at 844‑MY‑CMEMS (844‑692‑6367).

Important Safety Information The electronics are not affected by interference produced by most common household electrical equipment. Electromagnetic interference from theft detection systems, airport security systems, etc., could make it difficult to take sensor measurements. However, it is highly unlikely that you would be taking measurements when you are close to these devices. Electric Blankets, waterbeds, or metal in the vicinity of the antenna could cause interference. If so, move the electric blanket or metal out of the room. If you have a waterbed, take the measurement in another room.

Patient Electronics System The Patient Electronics System reads the pressure measurement from your sensor wirelessly. The handheld unit has a touchscreen which can be used to set up the unit and change settings. You can connect the electronics to either a regular landline telephone, cellular adapter, or a Wi-Fi‡ adapter. The Patient Electronics System consists of the electronics unit and receiving antenna (encased within the pillow), and a handheld unit.

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Figure 10. The Handheld Unit

Figure 11. The Pillow

Setting Up the Patient Electronics 1. Remove the Patient Electronics System from the travel case. 2. Place the unit where you will lie down to take your reading. 3. Remove the power adapter and power cable from the storage pocket in the travel case. Figure 12. Power adapter and power adapter cable

Figure 13. Power cable

4. Insert the power cable into the power adapter. 5. Plug the power adapter cable into the power connector plug so they are connected all the way. Press the connected plugs securely into the molded groove on the back of the electronics unit.

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Figure 14. Plug connections

6. Plug the power cable into the wall electrical outlet. Figure 15. Wall connection

7. If you use a landline telephone to send your readings, connect the telephone cord. To complete the setup of your system, refer to the following section.

Connectivity Method The Patient Electronics Systems are equipped with pre-installed USB cellular adapters. You can use the USB cellular adapter free of charge. If you do not have coverage in your area, you can use a telephone line or a Wi-Fi‡ adapter as described below. To order a Wi-Fi adapter, contact Technical Support.

With a Telephone Line To connect your system to a landline telephone: 1. Insert one end of the telephone cord into the back of the electronics unit. A telephone cord is provided in the system package. 2. Insert the other end into a telephone jack in the wall. You can use the phone splitter if the telephone jack already has a phone line connected to it. Figure 16. Telephone cord connection

3. Use a screwdriver 1 to unscrew the access door that is under the pillow. 4. Open the access door. A USB cable is located in the compartment. Make sure that you do not unplug this cable. Do not untwist this cable as it may affect electromagnetic emissions. 1

A recommended screwdriver is a P1 Phillips head screwdriver. 11

Figure 17. Access door

5. Disconnect the USB cellular adapter from the USB cable. Figure 18. USB cellular adapter

Figure 19. USB cellular adapter and cable connection

6. Close the access door and replace the screw. NOTE: If your system is connected to Wi-Fi‡, and you want to connect to a landline telephone, remove the Wi-Fi adapter from the USB port.

With a Wi-Fi Adapter To set up a Wi-Fi‡ adapter: 1. While the electronics unit is powered off, insert the Wi-Fi adapter into either USB port on the rear of the unit. Figure 20. Wi-Fi adapter

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Figure 21. Wi-Fi adapter inserted into USB port

2. Press the power button on the back of the electronics unit to turn it on. A blue LED lights up. Once the electronics unit is powered on, the system prompts you to select a network and enter the password using the handheld unit touchscreen. NOTE: If your system has a cellular adapter and Wi-Fi adapter plugged in, the system attempts to connect to Wi-Fi first.

Steps for Taking a Reading 1. Press the power button on the back of the electronics unit to turn it on. A blue LED will light up. Figure 22. Power button

2. Remove the handheld unit from the storage area on the right side of the pillow. Make sure that the cord of the handheld unit is attached to the back of the electronics unit. Figure 23. Handheld unit in storage area

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Figure 24. Cord of the handheld unit

3. After the electronics unit powers up, a screen with both a Start Button, an Options Button, and an Off Button appears (figure below). Once you see this screen, you know that the system is ready to use. Figure 25. Initial Startup Screen

4. Carefully lie down in a comfortable position on the pillow while being aware of your surroundings. The thickest part of the pillow is under your head during the reading. Figure 26. Position on pillow

5. Once in position, press the green round button below the touchscreen on the handheld unit. Figure 27. Remote button

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6. Lie still on the pillow. The system will guide you with voice prompts. The screen below appears while the system searches for a signal. If your body position is good you will hear, “Good position on pillow. Stay still.” If you hear, “Shift slightly on pillow,” check your surroundings and carefully change your body position. Small movements work best. If you have difficulty hearing the voice prompts, follow the instructions on the screen or have someone assist you in taking your reading. If you have difficulty seeing the instructions on the screen, follow the voice prompts or have someone assist you in taking your reading. If you have difficulty obtaining a good position on the pillow, refer to the Troubleshooting the Patient Electronics System section or contact Technical Support. WARNING: Avoid placing the handheld unit directly over the pillow during a reading. Figure 28. Acquiring signal

7. After the “Measuring” message appears, remain still for about 18 seconds while the music plays. When the reading is finished, you will hear “Reading completed, you may get up.” Your information is automatically sent to your doctor. Figure 29. Reading in Progress

8. Once transmission is complete, the electronics unit turns off automatically. The preferred method for taking a reading is to use the green button below the screen on the handheld unit as described above. An alternative method is to use the green Start indicator on the touchscreen. If you cannot complete a reading after following the above steps, refer to the Troubleshooting the Patient Electronics System section or contact Technical Support.

Troubleshooting the Patient Electronics System Table 4. Troubleshooting Problem

Symptom

Solution

Cannot get a signal

Signal Strength bar never goes above 70% and never turns green Voice continues to indicate low signal Not able to complete a reading successfully

Check for any noticeable damage to the unit. Make sure there is no metal near the pillow. Make sure there is no electric blanket near the pillow. Carefully reposition yourself on the pillow. Call Technical Support.

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Table 4. Troubleshooting Problem

Symptom

Solution

Reading completes but cannot send data to your doctor

Error message repeats “Connecting to send reading” Error message says “Unable to complete transmission” Error message says “NO DIALTONE”

Check the USB cellular adapter, phone line, or Wi‑Fi‡ adapter. Make sure the phone line is working or you are getting adequate signal strength on your wireless connection. Make sure the phone line is not busy. Make sure your Wi‑Fi network name and password are correct. Make sure the electronic unit is dialing the phone line with the correct pre-fix, if necessary. Call Technical Support.

Touchscreen does not respond

Buttons are not activated by repeated presses

Turn off the system by holding in the power button on the back of the electronics unit for greater than 5 seconds. Turn on the system and retry to use the touchscreen. If the problem is not resolved, call Technical Support.

Takes a long time to get a reading

Takes a long time (>30 seconds) to get a good signal System loses signal during reading and must re-start

Carefully reposition yourself on the pillow until the Signal Strength bar shows a higher signal strength and turns green. Make sure there are no electronics or metal in the vicinity of the measurement that may cause interference. Use the orientation ball to find the correct position. Call Technical Support.

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Table 4. Troubleshooting Problem

Symptom

Solution

Reading completes but is rejected by system

Error message says to repeat reading and reposition pillow away from any cords or metal objects

Remove any cords or metallic objects near the pillow or the pillow cable. Make sure there is no metal near the pillow. Make sure there is no electric blanket near the pillow.

Numeric error message

Error message with a number appears on the screen

Note the error. Select the OK button to acknowledge the error, wait for the error to transmit, and let the electronics unit shut down. Call Technical Support.

Error #0

There is a problem with the connections in the system such that important information cannot be sent.

Error #1

The electronics system recorded an obviously incorrect value for the atmospheric pressure.

Error #2

The two atmospheric pressure sensors in the electronics system do not agree.

Error #3

Important data needed to make a measurement was not available.

Error #4

The internal settings values needed to make a measurement were missing or damaged.

Error #5

The atmospheric pressure sensor indicated an error in recording pressure or temperature.

Error #6

An important part of the software was not able to run.

Error #7

Too many consecutive USB screen freeze.

Warning #5 message appears on the screen

Note the warning. Turn off the electronics unit from the Options menu. Restart the electronics unit. If the warning appears a second time, the time back-up battery may be dead. Continue to take readings until you are able to replace the battery. To replace the battery: 1. Use a screwdriver to remove the access door marked with a battery symbol on the back panel of the electronics. 2. Turn off and unplug the unit. 3. Remove the screws on the access door.

Time of Day Clock is incorrect

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