Preventice®, Inc., announced today it has enhanced the ability of its BodyGuardian® Remote Monitoring System (BodyGuardian) to identify anomalous ECG rhythms and will now provide greater precision in identifying the type of arrhythmias that occurred when reporting events to care teams. The new capability supports the clinical scalability of BodyGuardian by increasing clinician efficiency as identified events are reviewed to confirm arrhythmia classifications.
According to Preventice co-founder, president and CEO, Jon Otterstatter, the company has improved on the original diagnostic powers of the BodyGuardian by increasing from five to 22, the number of classifications for ECG selection and arrhythmia analysis. The original five classification algorithms are licensed from Mayo Clinic. The additional classifications are also derived from proven algorithms and increase the precision of the event description that is delivered to the physician.
"The first generation BodyGuardian met the needs of physicians by delivering a high-quality signal, solid data security and a clinically relevant user interface," said Otterstatter. "The release of enhanced symptom identification raises the bar by increasing the precision of information we provide to physicians. Doctors will still make the call, but they will go right to the ECG strip with a minimal amount of time. Given that BodyGuardian provides monitoring over days or weeks, this automated data discovery can be truly game changing."
A key system advantage is that BodyGuardian provides a wider context of the patient's biometric data for the physician to review with events. With each event, the physician receives trend data for key biometrics including respiratory rate, heart rate and activity rate. This allows the physician to review a targeted set of patient data to better understand event circumstances and the patient's condition in total, as they diagnose and develop the patient's care plan.
Since the commercial launch of BodyGuardian, Preventice has been working hand-in-hand with physicians through clinical trials and customer launches to ensure ongoing system enhancements are aimed at improving system usability and care team efficiency. The direct input from clinical teams has provided real-world insights to guide and prioritize product enhancements.
Directly aligned to customer input is the deployment of over-the-air system updates. This functionality supports wide-range scalability for customers. As customers expand their BodyGuardian usage with ever-larger patient populations, the ability to seamlessly deploy product updates and ongoing maintenance releases without physician or patient support is critical to minimize the logistic coordination required by the care team for each patient. This update allows for the delivery of enhancements, new releases and feature modifications that are fully controlled and triggered by Preventice working in concert with the care team. The flexibility of the support allows updates to be made available to an entire institution or targeted to a specific patient's remote monitoring needs.
Additionally, the latest release deploys user interface updates to the care team portal that are derived from the ongoing communication and learning with customers. This includes updates that allow clinicians to leverage the added classification support and streamline the ECG review process; default user and navigation preference improvements; deployment of additional user filtering capabilities; and finally, workflow optimizations that minimize the steps needed to review individual events.
Finally, SnapStrip alternatives using different adhesives have also been added as kit options. The different SnapStrips give clinicians options for patients that have skin sensitivities or specific needs for removing and reapplying the device multiple times. Clinicians can select a SnapStrip that best meets the needs of the patient and the prescribed use.
"Delivering the enhanced classification, as well as the other product updates, is part of our overall business strategy of continuous improvement. We are committed to innovations that fit within the care team's workflow, are easily scalable within an institution and ultimately provide the best possible patient care," said Otterstatter. "All of those factors are critical in our long-term planning for BodyGuardian to ensure it meets and exceeds the needs of our customers and their patients."
Preventice has been selling the BodyGuardian in the United States since the beginning of 2013, after receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2012. Developed in collaboration with Mayo Clinic, the BodyGuardian uses sophisticated algorithms to support remote monitoring for individuals with cardiac arrhythmias. The BodyGuardian is approved for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients. Preventice recently announced that the company received ISO 13485: 2003 certification and that the BodyGuardian has received CE Mark approval, clearing Preventice for European sales.