Abbott (NYSE:ABT) said today that its St. Jude Medical (NYSE:STJ) subsidiary won CE Mark approval in the European Union for the ConfirmRx insertable cardiac monitor, touting as the world’s 1st smartphone-compatible ICM.
The continuous heart monitor is designed to work with St. Jude’s myMerlin mobile app to allow physicians to remotely follow patients and diagnose arrhythmias. Abbott said it’s on the market in 10 “select” countries in Europe, with a full release slated for the 2nd quarter. The FDA is also reviewing the device, the Chicago-area healthcare giant said.
“Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance,”cardiac arrhythmias & neuromodulation CMO Dr. Mark Carlson said in prepared remarks. “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.”
“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,” added Dr. Georg Nölker of Herz-und Diabeteszentrum NRW, Ruhr-University of Bad Oeynhausen, Germany, 1 of the 1st to implant the device. “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.”
“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,” said another early implanter, Dr. Christopher Piorkowski of the University of Dresden Heart Center in Dresden.