History: For 27 years, Lorene Bardy, the late wife of Bardy Diagnostics founder Gust Bardy, M.D., had a rare heart rhythm disorder. Lorene had been seen by many expert electrophysiologists, but the lack of ability to visualize and record her P wave left her without answers to her specific type of arrhythmia. At the young age of 52, Lorene suddenly passed by cardiac arrest, which Dr. Bardy attributes to the suboptimal state of diagnostic technologies. As a practicing electrophysiologist since 1983 and motivated by the experiences of his late wife, Dr. Bardy began his relentless mission to take the many unmet medical needs in cardiac care and turn it into a tangible and life-changing medical solution. In 2013, Bardy Diagnostics was formed with the unique perspective of both physician and husband. Dr. Bardy used his expertise to develop transformative cardiac monitoring solutions that help physicians obtain more accurate information about actionable events in the hopes of saving lives.
Solution: The Carnation Ambulatory Monitor (CAM™)
The Carnation Ambulatory Monitor (CAM™) is the first non-invasive, P-wave centric ambulatory cardiac monitor and arrhythmia detection device designed to elevate signal detection, patient compliance, and physician care procedures. Through advanced compression algorithms to more effectively process signals, and short patch vectors to overcome signal-to-noise limitations, the technology is rigorously optimized to ensure a clear P-wave recording and superior detection of heart rhythms. The form and placement of the device are designed to improve comfort for patients, while generating higher rhythm specificity. The sensor is placed over the sternum, on top of the heart, this location prevents any noisy muscle stimulation and enhances the capture of the P-wave signal.
The hourglass form enables comfort in this area and was thoughtfully designed to resolve the
underserved needs of comfort for the female chest. With a lifestyle-enabling form factor patients can remain going about their daily activities comfortably and confidently. CAM™ provides options for a 48-hour, 7- or 14-day wear period and continuous 24/7 monitoring using BDxCONNECT, a versatile patient management portal. When experiencing symptoms, patients simply push the button on the device, and a report is sent to their physician to analyze and determine if intervention is needed. Once the wear period is finished, the data is uploaded and a more in-depth view of ECG data is generated through multiple fields of concise analysis. In an industry-leading two-day report turn-around, physicians have an improved resolution of ECG data, supplying more heart rhythm information and allowing for the detection of many unrecognized patterns and more clinically-actionable diagnoses.
Generating Impact: The CAM patch is rapidly becoming the new standard of care in cardiac monitoring and the trusted cardiac monitor of choice by electrophysiologists, cardiologists, and physicians globally. The 14-day CAM patch in addition to the 2- and 7-day CAM patches are all commercially available and cleared by the FDA, actively being used to improve cardiac care across the U.K., U.S., and Canada. The commercialization of the product and strong clinical evidence are clear indicators of the significance of the technologies impact. With further development and clinic expansions, it is evident the improvements Bardy’s technology will continue to make on greater arrhythmia detection and diagnosis for patients around the world.
The life-saving potential of Bardy’s technology continues to evolve and benefit patients in different avenues. The CAM patch currently extending its use in newly established protocols at hospitals across Seattle, WA, to monitor cardiac rhythms for COVID-19 patients on outpatients on Hydroxychloroquine (HCQ). HCQ has been demonstrated to prolong the QT interval, resulting in a potentially lethal arrhythmia called Torsades de Pointes. The unique ability of the BardyDx CAM Patch to detect and record low frequency, low amplitude cardiac rhythms will be especially valuable in measuring QT intervals and diagnosing Torsades de Pointes.
To date, the CAM patch has been used to monitor 40,000 + patients
and acceptance of the product continues to rapidly grow as a result of continuously positive patient and physician reception of the unique technology. Promising clinical evidence and peer-reviewed data have additionally demonstrated the advantageous weight of the CAM patch and exemplified a dominant superiority over existing monitors to provide a greater impact on clinical decisions, patient comfort, and arrhythmia diagnosis.
