KIRKLAND, Wash.--(BUSINESS WIRE)--Cardiac Insight, Inc., a U.S. developer of wearable medical devices and diagnostic software, announced today that its FDA-approved Cardea SOLO™ ECG monitoring system is available for diagnosing atrial fibrillation following cardiac ablation. The company’s cardiac monitoring device supports a recent formal consensus statement by experts from 11 leading international cardiology organizations that recognizes the use of wearable sensing devices in patients who have undergone atrial fibrillation (AFib) 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, a common rhythm disorder that increases the risk of heart failure and stroke. The expert consensus statement was collectively developed by the Heart Rhythm Society, European Heart Rhythm Association, European Cardiac Arrhythmia Society, among several others (http://www.hrsonline.org/Policy-Payment/Clinical-Guidelines-Documents/2017-HRS-EHRA-ECAS-APHRS-SOLAECE-Expert-Consensus-Statement-on-Catheter-and-Surgical-Ablation-of-Atrial-Fibrillation).
Cardiac ablation is an invasive procedure that is used to eliminate atrial fibrillation. Among its many applications, Cardea SOLO is a new, distinctive, cost-effective and timely solution for monitoring the effectiveness and results of atrial fibrillation ablation.
“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,” said Robert Hauser, MD, FACC, FHRS, Past President Heart Rhythm Society (1983-84) and Senior Consulting Cardiologist (retired), Minneapolis Heart Institute. “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 to eliminate the need for expensive and time-consuming third-party service centers and puts the control of patient data, analysis and processing in the hands of physicians and their staffs.
“Cardiac Insight’s Cardea SOLO is a game changer in the cardiac med-device market,” added Brad Harlow, Co-Founder and Chief Executive Officer at Cardiac Insight, Inc. “Cardea SOLO is an off-the-shelf product. It is not a service; so there is no lag time due to enrollment with a tech or third-party service company. The device offers physicians immediate access to improved reporting and analysis of heartbeat-to-heartbeat data.”
The Cardea SOLO sensor records ECG data and patient symptoms. The wearable sensor is small, lightweight (approximately the weight of three quarters), lead-less, water-resistant and single-use disposable. Patients can wear Cardea SOLO comfortably 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.
About Cardiac Insight:
Cardiac Insight, Inc. (www.cardiacinsightinc.com) is a U.S. developer of advanced body-worn digital health care information devices for cardiology, respiratory and other complex disease states. The company’s technologies and systems are created using advanced algorithms and software that provide improvements in mean time to diagnosis. Cardiac Insight’s mission is to invent complete and progressive solutions for unmet clinical needs on behalf of physicians, clients and payers. Cardiac Insight was founded in 2008 and is based in Kirkland, WA.