Press Release Summary:
Featuring 510(k) clearance from U.S. FDA, BodyGuardian Remote Patient Monitoring System (BodyGuardian RMS) detects, records, and wirelessly transmits physiological data in support of remotely monitoring non-lethal, cardiac arrhythmias in ambulatory patients.Â Sensor attached to patient's chest collects important data – ECG, heart rate, respiration rate, and activity level, which can then be transmitted toÂ mHealth platform for storage and later retrieval by physicians.
Original Press Release:
Preventice® Announces Commercial Availability of BodyGuardian Remote Patient Monitoring System(TM)
Multiple clinical trials and pilot programs underscore growing interest in wireless patient monitoring technology
MINNEAPOLIS--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.
In good company: Strategic partnerships
According to Otterstatter, the strength of the BodyGuardian RMS comes from the enviable ecosystem of partners that Preventice has established, which has allowed it to build a remote monitoring platform that is secure, reliable and scalable.
"From day one, we made it a priority to affiliate the Preventice brand with leaders in health care, wireless devices, sensor technology, and ISO quality manufacturing processes," said Otterstatter. "As a result, we have built a remote monitoring platform that meets the most stringent privacy and security standards, that is reliable in a variety of clinical and non-clinical settings and that exceeds the usability expectations of today's sophisticated consumers."
For example, Otterstatter noted, that the BodyGuardian RMS was developed in collaboration with Mayo Clinic (which developed the algorithms on which the BodyGuardian RMS technology is based), STMicroelectronics (which provided the sensor technology), and Samsung Electronics (which provided the dedicated wireless environment that contributes to the security and clinical reliability of the BodyGuardian RMS).
Preventice has licensed the remote monitoring algorithms for the BodyGuardian Remote Monitoring System from Mayo Clinic. The BodyGuardian 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 later retrieval.
The BodyGuardian sensor adheres to the patient's skin and is smaller than a cell phone, giving patients complete mobility and freedom to go about their normal lives without restriction. Physicians and medical professionals can securely view the captured medical information anytime, any place on devices such as the iPad®, or online. Physicians can retrieve patient data and reports, or choose to receive alerts based on changes in select biometrics.
Preventice, a leading developer of mobile health applications and remote monitoring systems, aims to engage patients with their care plans and close the patient engagement gap--the half trillion dollar cost created by patients failing to follow individual care plans. Technology from Preventice creates a continuous connection and exchange of data between health care providers, life science companies and patients. Current applications from Preventice address high-cost and chronic conditions and health management opportunities, including prescription medication management, cardiac care, sleep apnea, diabetes management, and migraine headaches. Preventice is headquartered in Minneapolis, with offices in Rochester, Minn., and Fargo, N.D. For more information, visit www.preventice.com.
For more information:
Barbara Tabor, APR
Tabor Communications Consulting for Preventice