Dec 4 2012
Preventice, Inc. announced today that its BodyGuardian Remote Patient Monitoring System (BodyGuardian RMS) will be commercially available in early 2013. Meanwhile, clinical trials are underway in the United States and Europe to quantify the impact of the BodyGuardian RMS on clinical care delivery. Preventice is demonstrating the BodyGuardian RMS this week at the mHealth Summit, one of the mobile health technology industry's leading conferences, in Washington, D.C., December 3-5, 2012.
"We're quickly approaching two significant milestones for the BodyGuardian RMS with the commercial availability of the system in early spring and robust clinical trial activity here in the United States and abroad. The clinical trial volume is a direct indicator of significant interest in BodyGuardian by early adopters and it demonstrates their belief that Preventice is poised to facilitate change in health care," said Jon Otterstatter, co-founder, president and CEO of Preventice. "We're confident that the BodyGuardian has the potential to become a key element of integrating care management and behavior change with any health care provider's digital health delivery program. BodyGuardian RMS supports efforts to increase the efficiency and effectiveness of chronic disease management while empowering patients to take a more proactive role in their health care."
Clinical trials 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 influences 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.
Trials are currently being conducted with Mayo Clinic in Rochester, Minn.; Sanpietro Clinic in Milan, Italy; and Bordeaux Hospital University Center (CHU) in Bordeaux, France--all with the intent to analyze and quantify the clinical impact of advanced monitoring for capabilities such as remote transmission of ECG signals, on-demand event transmission, and centralized analysis of significant amounts of data.
"Sanpietro Clinic is pleased to be working with Preventice to provide our patients with remote cardiac monitoring," said Marcello Ruspi, MD, vascular surgeon, clinical director, Sanpietro Clinic. "Many of our patients have cardiac disease and the BodyGuardian RMS will allow us to better monitor and care for them at home, just as if they were at the clinic. Making it easier for patients to stay healthy is the goal here at Sanpietro."
In addition to the clinical trials that are currently in progress, Otterstatter noted that a new clinical trial to study the use of remote monitoring to manage default hospital admissions for cardiac patients is planned for 2013 at Mayo Clinic.
Preventice received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August, enabling the mobile health solutions company to market and sell BodyGuardian to hospitals and clinics for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients.
According to Michael Emerson, senior vice president of marketing for Preventice, the company has received an encouraging interest in the BodyGuardian RMS and will make the product available to hospitals, clinics and testing facilities in the U.S. and Europe during the first quarter of 2013.
"Doctors need solutions that allow them to monitor critical measures such as ECG, respiration, and body movement in at-risk patients," said Emerson. "BodyGuardian will ultimately allow one doctor to oversee many patients, thus ensuring the health and safety of individuals as they go about their day-to-day life. This one-to-many approach will ultimately change how health care is delivered for many common cardiac diseases."
Emerson added that in addition to its collaboration with Mayo Clinic (which developed the algorithms on which the BodyGuardian RMS technology is based), Preventice is working with STMicroelectronics, and Samsung Electronics to bring the BodyGuardian to market.