Heart Monitoring, Everywhere You Go

When you can't be with your doctor, Abbott's Confirm RxTM ICM can be with you, tracking your heart's performance.

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Products and Innovation | Apr. 17, 2018

You've felt this dizziness before. The heart palpitations. Maybe chest pains. Shortness of breath. It comes and goes but when it comes, you know it because you feel it.

You're not completely sure what's behind it. You've never been diagnosed with any heart issues. Or maybe you have but this... this is different.

If these symptoms continue, you should get with your doctor to check it out.

Of course, just like visiting a mechanic when your car is making a noise, when you get there... nothing happens. You're fine. Ticking like a clock.

It's impractical to sit and wait it out for hours, not exactly hoping it happens again but wanting answers. It's also unlikely you'll be close to your doctor the next time it does. It's just how the world tends to work.

"Whenever you're dealing with rhythm problems in the heart, being able to identify risk can sometimes mean the difference between life and death. The key is finding out what happened: What’s the cause of your symptoms?" said Dr. Sean C. Beinart, MD, FACC, FHRS, Cardiologist.

How can you diagnose these nomadic symptoms from your body? Especially if you've experienced cardiac problems before?

An insertable cardiac monitor (ICM), which is placed just under the skin during a minimally invasive procedure to continuously monitor your heart's rhythm for signs of atrial fibrillation.

"Prior to the evolution of this technology, the ability to monitor patients was really short-lived. But this allows the monitoring to continue and allows the patient to continue to live their lives unhindered," Beinart said.

Even better: Abbotts Confirm RxTM ICM, which is designed not only to detect arrhythmias but also to wirelessly transmit data via Bluetooth to your smart phone for data transmission to the Merlin.netTM Patient Care Network so your doctor has real-time access anywhere in the world to how your heart is performing.

Abbott's ICM is small and slim. It continuously monitors the heart — taking the onus off you — but offers the capability to instantly record events through one-touch programming via a smartphone app, should you choose to do so.

"The stakes are very high," Beinart said. "What the Confirm Rx does is it gives both me and my patient peace of mind that we've got them covered."

IMPORTANT SAFETY INFORMATION

CONFIRM RX

Insertable Cardiac Monitor

RX ONLY

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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

CONTRAINDICATIONS:

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

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.

ADDITIONAL INFORMATION:

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 schedules and enable or disable features on a patient's myMerlin™ for Confirm Rx™ ICM 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 Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ for Confirm Rx™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ for Confirm Rx™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was 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.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.