Abbott Says Newly CE Marked Confirm Rx™ ICM Represents New Paradigm May 9, 2017
The world’s first smartphone-compatible Insertable Cardiac Monitor (ICM) has gained CE mark and seen first use. Abbott says its device will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy.
Abbott has gained CE Mark and seen first use of its new Confirm Rx™ ICM. Since CE Mark approval, implants have already taken place 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.
Traditional remote monitoring has required bulky handheld or bedside transmitters, which limit patient mobility. The new interactive myMerlin mobile app replaces these passive transmitters. Indeed Abbott is claiming a new paradigm in the connectivity of cardiac devices by incorporating wireless technology which allows the device to communicate directly and securely to the app downloaded onto a patient’s smartphone. In doing so it also 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.
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.
“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. Dr. 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.”
“Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance,” said Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses. “The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.”