News | Implantable Cardiac Monitor (ICM) | May 06, 2019

Abbott Launches Next-generation Confirm RX Implantable Cardiac Monitor

Smartphone-compatible ICM offers more accurate, 24/7 monitoring of heart rhythm disorders

Abbott Launches Next-generation Confirm RX Implantable Cardiac Monitor

May 6, 2019 — Abbott announced the launch of a new, smarter heart monitor for better arrhythmia detection — positive news for people at risk for irregular heartbeats. Now with CE Mark in Europe and U.S. Food and Drug Administration (FDA) clearance, the next-generation Confirm Rx insertable cardiac monitor (ICM), a paperclip-sized implantable device, combines smartphone connectivity and continuous, remote monitoring to track unpredictable heart rhythm problems for fast and accurate diagnosis.

An arrhythmia is an abnormal heart rhythm that can lead to symptoms such as the feeling that the heart is racing, dizziness, shortness of breath or fainting. Living with an irregular heartbeat can lead to constant questions for people battling symptoms. For the 33.5 million people living with atrial fibrillation (AFib) — the most common arrhythmia — many do not even know they have the condition.

Inserted just under the skin in the chest above the heart during a quick, minimally invasive outpatient procedure, the Confirm Rx ICM device is the only ICM on the market, according to Abbott, that syncs to a smartphone via Bluetooth and transmits information to the physician to help identify irregular heartbeats quickly. Abbott's mobile app eliminates the need for an additional transmitter and is user-friendly health technology translated in nearly 40 languages.

Wearables used to track cardiac arrhythmias have limitations when it comes to making a clinical diagnosis. Many require recharging at night, which can lead to missing irregular heartbeats that may occur sporadically and infrequently. Others require some level of interaction by the person to record symptoms, which may not be top of mind when feeling light headed, dizzy or experiencing a rapid heart rate.

"The rise in health monitoring has undoubtedly increased awareness of arrhythmias such as AFib, but many of these devices still aren't leading to an improved diagnosis or solving the key clinical challenges for people at risk," said Sean Beinart, M.D., a cardiologist with Adventist Healthcare in Rockville, Md. "Like a guardian for heart health, Confirm Rx ICM can relay important data about a person's heart rhythm through their smartphone and alert their care team to a potentially dangerous heart event. With Abbott’s new technology, I can better identify risk — making it actionable for me and life-changing for my patient."

Unlike other monitoring technology that can lead to gaps in arrhythmia detection, Confirm Rx ICM provides continuous 24/7 monitoring. The new detection technology in Confirm Rx ICM reduces false detection by 97 percent and avoids alerting physicians of irregular heartbeats that may not actually signal a cardiac arrhythmia. The next-generation version of Abbott's Confirm Rx ICM incorporates new SharpSense technology.

Approximately 6 million Americans are afflicted with irregular heartbeats, including 28-year-old Becca Bartling. Choosing Abbott’s Confirm Rx ICM meant that she could continue doing yoga, mountain biking and managing a resort on her family’s fourth-generation cranberry farm in rural Manitowish Waters, Wis. Becca said she chose Confirm Rx ICM for its convenience as there’s no need for additional monitoring equipment or a recharging station. There is also no need to rely on the patient to take action, carry a remote or go to sleep next to a separate bedside transmitter. After hearing that her Confirm Rx device would be compatible with an app on her phone, she immediately told her doctor: "I definitely want the Confirm Rx, I want that one. This device is a better option because of my lifestyle."

David Bartling, Becca's husband, recalled a fainting episode during the first week of having the device. "It was the scariest thing that I saw when she would just seem fine and the next thing you know she passed out," David said. "The Confirm Rx helped us feel comfortable with getting answers we were looking for. It’s reassuring because it's simple, small and new technology."

Becca's physician took the data and was able to quickly identify the cause of her fainting: bradycardia, which means her heart was beating too slowly and causing her to pass out. After her accurate diagnosis with the help of Confirm Rx ICM, Becca received an Abbott pacemaker to manage her condition and allow her to return to harvesting the cranberry farm and leading a fuller life.

For more information: www.cardiovascular.abbott

 

Related Implantable Monitor Content:

FDA Clears Fever-Detecting Cardiac Monitor From Biotronik

Confirm RX First Implantable Cardiac Monitor to Gain Approval Using Mobile Phone App Monitoring

Next Generation Medtronic ICM Offers Remote Programming and Improved Longevity

VIDEO: Rising Interest in Remote Monitoring of EP Devices in the COVID-19 Era — Interview with Robert Kowal, M.D.

FDA Clears Boston Scientific LUX-Dx Insertable Cardiac Monitor

Biotronik Launches Biomonitor III Injectable Cardiac Monitor in Europe

Real-time vs. Post-monitoring Review Approaches to Holter, Event Recording

VIDEO: Editor's Choice of Most Innovative New Technology at ACC.17

Implantable Cardiac Monitors Detect High Rate of Atrial Fibrillation in Previously Undiagnosed High-Risk Patients

VIDEO: Advances in Electrophysiology Technology

Related Content

The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device

The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device

News | Cardiac Diagnostics | July 01, 2021
July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc.
Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Detecting heart disease with OCT imaging of the eye.Getty Images

Ophthalmic optical coherence tomography (OCT) scan view of the macula in retina with vessels. Getty Images
 

News | Cardiac Diagnostics | March 08, 2021
March 8, 2021 — In a new study from Shiley Eye Institute at UC San Diego Health, researchers have identified a potent
Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia.

Alivecor's pocket ECG system allows consumers or cardiologists to record a single lead ECG strip on a smartphone. AI algorithms can determine if their ECG is normal or abnormal and identify the arrhythmia. 

News | Cardiac Diagnostics | March 03, 2021
March 3, 2021 — AliveCor recently announced a new collaboration with AstraZeneca to research new disease management s
A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images Health disparities in cardiovascular disease.

A study of more than 100 million Americans in 3,123 counties found a correlation between cardiac death and their level of income. Getty Images

News | Cardiac Diagnostics | February 02, 2021
February 2, 2021 — A new study has found in the U.S.
A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

A new study highlights the importance of continued public education regarding the risks of cigarette smoking and the failure of dual use with vaping to reduce cardiovascular risk. Getty Images

News | Cardiac Diagnostics | January 06, 2021
January 6, 2021 — Smoking traditional cigarettes in addition to using e-cigarettes results in harmful health effects
The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia.

The Mesuron Inc. Avalon-H90 uses magnetometers to detect myocarditis in patients without any physical contact. It uses ventricular repolarization dynamics analysis software to look for abnormalities. The vendor said it is more specific than using ECG. It detects the multidimensional dynamics of the electrical activity caused by differences in functions of electrical action potential of normal heart tissues and abnormal ones with hypoxia. 

News | Cardiac Diagnostics | October 06, 2020
October 6, 2020 — A new technology being developed by U.S.-based Mesuron Inc.
With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...