Preventice to launch BodyGuardian RMS; US/European trials get under way
Preventice has made plans to launch its BodyGuardian remote patient monitoring system (RMS) in the US in early 2013. Meanwhile, clinical trials are under way in the US, France and Italy to quantify the impact of the BodyGuardian RMS on clinical care delivery. The trials will target the use of remote monitoring for various treatment scenarios, including:
â¢ post-surgical cardiac patients to evaluate how monitoring cardiac rhythms remotely influences all phases of hospital recovery;
â¢ patients with congestive heart failure to determine early warning of decompensated heart failure and delivery of more timely interventions that can prevent more serious and expensive complications; and
â¢ continuous monitoring of non-surgical, infrequently symptomatic patients as they go about their daily lives, with the objective of detecting potential arrhythmias by tracking ECG, respiratory rate and activity.
Trials are currently being conducted with Mayo Clinic in Rochester, MN; Sanpietro Clinic in Milan, Italy; and Bordeaux Hospital University Center in Bordeaux, France, all with the intent to analyse and quantify the clinical impact of advanced monitoring for capabilities such as remote transmission of ECG signals, on-demand event transmission and centralised analysis of significant amounts of data. In addition to the trials that are currently in progress, a new trial to study the use of remote monitoring to manage default hospital admissions for cardiac patients is planned for 2013 at Mayo Clinic.
Preventice licensed the remote monitoring algorithms for the BodyGuardian RMS from Mayo Clinic. The system detects, records and wirelessly transmits physiological data to support remote monitoring of non-lethal, cardiac arrhythmias in ambulatory patients. Data is transmitted to the Preventice mHealth platform, where it can be stored for up to 30 days at a time. The BodyGuardian sensor adheres to the patient's skin, giving patients complete mobility. Physicians and medical professionals can securely view the captured medical information. Physicians can retrieve patient data and reports, or choose to receive alerts based on changes in select biometrics. Preventice received 510(k) clearance from the FDA in August, for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients.