Preventice, Inc., a leading developer of mHealth solutions, announced today the commercial availability of its BodyGuardian Remote Patient Monitoring System (BodyGuardian RMS).
Preventice received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2012, enabling the mobile health solutions company to market BodyGuardian for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients.
Developed in collaboration with Mayo Clinic, the BodyGuardian System uses sophisticated algorithms to support remote monitoring for individuals with cardiac arrhythmias. The BodyGuardian System allows physicians to monitor key biometrics outside of the clinical setting, while patients go about their daily lives. A small body sensor attached to the patient's chest collects important data, including ECG, heart rate, respiration rate, and activity level. Patient data can then be transmitted to physicians via mobile phone technology. This level of remote patient monitoring can create a constant connection between patients and their care teams.
Growing clinical demand for monitoring technology
According to a report from the American College of Cardiology, the American Heart Association Task Force, and the European Society of Cardiology Committee for Practice Guidelines, atrial fibrillation is the most common form of arrhythmia and the incidence increases with age, with stroke and heart failure the most common complications. In addition, the American Heart Association currently estimates that six million people in the United States have atrial fibrillation, and that number is expected to grow to 12 to 15 million by 2050.
Remote patient monitoring can aid in the diagnosis of atrial fibrillation by providing accessible ECG and rhythm monitoring in both symptomatic and asymptomatic people as they go about their daily lives. The technology can also support treatment efforts by allowing physicians to screen for high-risk atrial fibrillation patients, to validate treatment, show medication compliance, and monitor patients who are adjusting to anticoagulation medication. While the cost for treating atrial fibrillation—including hospitalization, in- and out-patient physician care and medications—grew to $6.65 billion in 2005, the use of remote monitoring technology by leading health care organizations has been steadily on the rise and is expected to continue its upward trajectory.
"There is a growing acceptance for monitoring patients outside the hospital setting," said Jon Otterstatter , co-founder, president and CEO of Preventice. "What sets the BodyGuardian RMS apart from other monitoring systems is our expertise in creating a continually connected environment between patients and clinical care teams, and our ability to meet the security and privacy needs of patients and the health care system."
Preventice is experiencing this demand firsthand, and is currently involved in multiple clinical trials in the United States and Europe to quantify the impact of the BodyGuardian RMS on clinical care delivery.
Clinical pilots with the BodyGuardian RMS are currently underway in the United States, France, and Italy targeting the use of remote monitoring for various treatment scenarios including:
- Post-surgical cardiac patients to evaluate how monitoring cardiac rhythms remotely influence all phases of hospital recovery,
- 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
- 24/7 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.