News | May 30, 2017

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

Abbott SJM Confirm RX Implantable cardiac monitor gains European CE mark approval

May 30, 2017 — Abbott recently announced European CE mark and first use of the new Confirm Rx Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. 

Since CE mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. The Confirm Rx ICM is designed to continuously monitor a patient's heart rhythm and proactively transmit information via the myMerlin mobile app, allowing physicians to follow their patients remotely and accurately diagnose arrhythmias.  

With the launch of the Confirm Rx ICM in European CE mark countries, Abbott has established a new paradigm in the connectivity of cardiac devices by incorporating wireless technology, which allows the ICM to communicate directly and securely to the app downloaded onto a patient's smartphone. Traditional remote monitoring has required bulky handheld or bedside transmitters, which limit patient mobility. The new interactive myMerlin mobile app replaces these passive transmitters and empowers patients to participate in their own care.

In addition to patient convenience, the device is slimmer than currently available ICMs. The Confirm Rx ICM also offers intuitive one-touch indication-based programming, and remote monitoring via the Merlin.net Patient Care Network, making the technology convenient for clinicians involved in procedure and follow up.

For more information and a demonstration of how to implant the Confirm RX, watch the VIDEO “Editor's Choice of Most Innovative New Technology at ACC.17.”
 

"The Confirm Rx ICM device will be an important tool for diagnosing patients with suspected arrhythmias, such as those who have experienced fainting or palpitations," said Georg Nölker, M.D., head of electrophysiology at the Herz-und Diabeteszentrum NRW, Ruhr-University of Bad Oeynhausen, Germany. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE mark. "The simple insertion procedure and small device size make this technology convenient for both patients and providers. Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator."

Christopher Piorkowski, M.D., head of the Department of Electrophysiology at the University of Dresden Heart Center in Dresden, Germany, and one of the first implanters, added: "The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF."

The myMerlin mobile app, available in over 35 languages, makes it easy for patients to stay connected to their physicians. Patients can record their symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate. Patients can also confirm their data was transmitted to their physician and get automatic alerts when they have missed a scheduled transmission, saving the clinic from having to follow up with the patient. The device also offers secure transmission of patient data. Recently, Abbott's Merlin.net Patient Care Network received one of the medical device industry's first Service Organization Control certifications (SOC2 certification), further confirming the safety and security of the company's remote monitoring network.

Currently the Confirm Rx ICM is available in select countries in Europe, with full European release expected during the second quarter of 2017.  The device is currently under review by the U.S. Food and Drug Administration. The estimated 2017 worldwide insertable cardiac monitor market is approximately $800 million and is growing by more than $100 million a year.

For more information: www.abbott.com

Related Content

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Feature | Atrial Fibrillation | January 27, 2021 | By John D. Day, M.D., T. Jared Bunch, M.D., and Matthew D. LaPlante
In our most challenging and distressing days, it is nice to think about a post-COVID-19 world. 
ECG with paroxysm correct form of atrial flutter. Getty Images

ECG with paroxysm correct form of atrial flutter. Getty Images

News | Atrial Fibrillation | December 23, 2020
December 23, 2020 — The American College of Cardiology (ACC) and the American Heart Association (AHA) has made two up
The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations. #AHA #AHA20 #AHA2020

The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evalu
The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting. #AHA #AHA20 #AHA2020

The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — Atrial fibrill...
The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  #AHA #AHA2020 #AHA20

The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 – Doctors from the Mo...

The study used cadaver hearts that were images with contrast enhanced MRI and the images used to create a 3-D computation model of the electrical activation in the heart and how it was influenced by adenosine and ablation. Find more images in the original article

News | Atrial Fibrillation | October 08, 2020
October 8, 2020 – People who suffer from persistent atrial fibrillation in the heart may find relief from a new treat
The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

News | Atrial Fibrillation | August 04, 2020
August 4, 2020 — Abbott announced the first enrollments in the TactiFlex PAF  investigational device exemption (IDE)