Abbott announced the CE mark and launch of its smartphone-compatible insertable cardiac monitor, designed to help physicians remotely diagnose arrhythmias, such as atrial fibrillation, and guide their therapy decisions.
The Confirm Rx device is the world’s first continuous heart monitor that is compatible with a smartphone. Picked up in Abbott’s $25 billion acquisition of St. Jude Medical, the device transmits data to the myMerlin app, which relays it to a physician on a preset schedule. It also alerts the patient if they have missed a scheduled transmission, the company said.
"The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation,” said Abbott Chief Medical Officer Mark Carlson, M.D., in the statement. “The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers."
The myMerlin app allows the patient to add notes to his or her symptoms, look at symptom history and record specific symptoms and send them to the clinic without waiting for a nightly sync, which is typical for traditional transmitters.
Traditional remote monitoring, Abbott said, requires bulky equipment that limits a patient’s mobility.
"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., of the Herz-und Diabeteszentrum NRW, Ruhr-University in Germany, one of the first physicians to implant the CE-marked device, in the statement.
"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,” Nölker said.
The device is on sale in selected countries in Europe, with a full rollout on the agenda later this year. It is under FDA review and is expected to tap into the $800 million insertable cardiac monitor market.