Live Life Without Skipping a Beat

DON’T IGNORE THE SYMPTOMS OF AN IRREGULAR HEARTBEAT (ARRHYTHMIA)

ABOUT CARDIAC ARRHYTHMIA

Up to 7.1 million people in the u.s. have an irregular heartbeat

7.1 MILLION

UP TO 7.1 MILLION PEOPLE
IN THE U.S. HAVE AN
IRREGULAR HEARTBEAT1,2

An irregular heartbeat may be highly treatable when properly diagnosed

HIGHLY TREATABLE

AN IRREGULAR HEARTBEAT MAY BE
HIGHLY TREATABLE WHEN
PROPERLY DIAGNOSED

An irregular heartbeat can make your risk of stroke 5 times higher

STROKE RISK

AN IRREGULAR HEARTBEAT CAN
MAKE YOUR RISK OF STROKE
5 TIMES HIGHER3

Find your rhythm

FIND YOUR RHYTHM

Heart palpitations, fluttering, chest pain or pressure and shortness of breath are all signs of a type of irregular heartbeat called Atrial Fibrillation (or AFIB). Abnormal heart rhythms and changes in heart rate can also cause dizziness or fainting, called syncope. Talk to your doctor right away if you’re experiencing any of these symptoms.

HOW IS AN IRREGULAR HEARTBEAT DIAGNOSED?

After a complete cardiac examination, your doctor will utilize diagnostic tests such as an EKG or Holter Monitor to understand whether your heartbeat is irregular.

Since you may not experience symptoms of atrial fibrillation or syncope while you’re at your doctor’s office, they will likely offer you other options to continuously monitor your heartbeat, such as a Holter Monitor or an Insertable Cardiac Monitor (ICM). ICMs allow you to record your symptoms and episodes as they occur over an extended period of time.

Confirm Rx™ ICM combines the slimmest ICM design with a smartphone app that allows you to record symptoms and makes monitoring your heart’s rhythm easy, effective, and discreet. Confirm Rx™ ICM is designed to detect arrhythmias, including atrial fibrillation that can cause your symptoms such as syncope and heart palpitations.4

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Confirm Rx™ ICM combines the slimmest ICM design with a smartphone app that allows you to record symptoms and detect irregular heartbeats (arrhythmias), including atrial fibrillation that can cause your symptoms such as syncope and heart palpitations.

CONFIRM RX™ ICM

Continuous heart monitoring uses your smartphone to record episodes of irregular heartbeat

EASY

CONTINUOUS HEART MONITORING
USES YOUR SMARTPHONE TO
RECORD EPISODES OF
IRREGULAR HEARTBEAT

The mobile app makes it easy to monitor and send your heart rhythm information to your doctor without interrupting your daily activities

EFFECTIVE

THE MOBILE APP MAKES IT EASY TO
MONITOR AND SEND YOUR HEART RHYTHM
INFORMATION TO YOUR DOCTOR WITHOUT
INTERRUPTING YOUR DAILY ACTIVITIES

Confirm Rx™ is the slimmest insertable cardiac monitor, designed to detect irregular heartbeat (arrhythmias),  available today

DISCREET

CONFIRM RX™ IS THE
SLIMMEST INSERTABLE CARDIAC
MONITOR AVAILABLE TODAY

What causes irregular heartbeat

WHAT CAUSES AN IRREGULAR HEARTBEAT?

Typically, your heart beats in a normal pattern with the upper chambers beating in coordination with your lower chambers. With an irregular heartbeat (arrhythmia), the cells that create the electrical signals in your heart cause random electrical activity, interrupting your normal heart rhythm. Rather than beating in a regular, coordinated rhythm, the upper chambers will quiver. This can lead to heart palpitations, chronic fatigue, syncope, decreased blood flow, inconsistent blood supply, and can even cause a stroke.

TALK TO YOUR DOCTOR

Make an appointment with your doctor today if you have any symptoms of an irregular heartbeat (arrhythmia). To prepare for your visit, click the button below for a list of questions that may be helpful to ask your physician or cardiologist.

Move to your own rhythm

TREATING AND MANAGING AN
IRREGULAR HEARTBEAT

MOVE TO YOUR
OWN RHYTHM

An important step to treating and managing an irregular heartbeat could be accurately diagnosing the heart condition using an ICM. Understanding the type and severity of your arrhythmia will help your doctor determine the best treatment pathway. Interventions used to treat an irregular heartbeat include ongoing monitoring, medication, a pacemaker, electrical cardioversion (an electric shock), or potentially an ablation procedure.

Reference:

  1. Cdc.gov. (2017). Atrial Fibrillation Fact Sheet|Data & Statistics|DHDSP|CDC. [online] Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm [Accessed 10 Nov. 2017].
  2. Fu Q, Levine BD. Pathophysiology of Neurally Mediated Syncope: Role of Cardiac Output and Total Peripheral Resistance. Autonomic neuroscience : basic & clinical. 2014;184:24-26. doi:10.1016/j.autneu.2014.07.004.
  3. Heart.org. (2017). AFib Awareness. [online] Available at: http://www.heart.org/HEARTORG/Conditions/Arrhythmia/AFib-awareness_UCM_476637_SubHomePage.jsp [Accessed 10 Nov. 2017].
  4. ADVERSE EVENTS: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Abbott
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1.651.756.2000
www.SJM.com
St. Jude Medical is now Abbott.

INDICATIONS

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

CONTRAINDICATIONS

There are no known contraindications for the implantation of the Confirm Rx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

PRECAUTIONS

Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedule and enable or disable features on patient’s myMerlin™ mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

LIMITATIONS

Patients may use their own Android‡ or Apple‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or Wi-Fi‡) available. The myMerlin™ app provides periodic patient monitoring based on clinician configured settings. Transmission data is resent if not sent successfully. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner. Bluetooth and the Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
© 2018 Abbott. All rights reserved.
23259 SJM-CFM-1117-0060 | Item approved for Global use.