Cardiac Insight, a US developer of wearable medical devices and diagnostic software, has announced that its US Food and Drug Administration (FDA)-approved Cardea Solo electrocardiogram monitoring system is now available for diagnosing atrial fibrillation following cardiac ablation.
According to a press release, the company’s cardiac monitoring device supports a recent formal consensus statement by experts from 11 leading international cardiology organisations that recognise the use of wearable sensing devices in patients who have undergone atrial fibrillation ablation procedures.
The formal acknowledgement of wearable sensors was one of a series of recommendations for treating the millions of patients who have atrial fibrillation. The expert consensus statement was collectively developed by the Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), European Cardiac Arrhythmia Society (ECAS), among several others.
“The societies’ recommendations will advance the treatment of atrial fibrillation, including the use of wearable sensors like Cardea Solo for diagnosing heart rhythm disorders and monitoring patients after atrial fibrillation ablation,” says Robert Hauser, past president, Heart Rhythm Society (1983-84) and retired senior consulting cardiologist, Minneapolis Heart Institute, Minneapolis, USA. “It is vital to detect and treat atrial fibrillation before it causes a stroke or heart failure. Cardea Solo provides the information doctors need in a more timely and cost-effective manner than currently offered by other wearable sensors.”
Cardea Solo is the first and only wearable cardiac sensor designed to eliminate the need for expensive and time-consuming third-party service centres and puts the control of patient data, analysis and processing in the hands of physicians and their staff.
The sensor records ECG data and patient symptoms. According to the press release, the wearable sensor is small, lightweight, lead-less, water-resistant and single-use disposable. Patients can wear Cardea Solo under their clothing for up to seven days and maintain their normal daily activities. “The design and ease-of-use also makes it more likely patients will wear the sensor and capture meaningful data for enhanced evaluation,” according to Harlow.