The list of companies hoping to offer heart failure patients peace of mind through at-home monitoring of their disease just got a bit longer.
Bioheart (Sunrise, Florida) said it has secured worldwide non-exclusive distribution rights to the Bioheart 3370 heart failure monitor, an interactive device designed to improve available healthcare to patients outside hospitals who are suffering from heart failure.
The device, made by RTX Healthcare (Noerresundby, Denmark), is FDA-cleared for marketing in the U.S. and has CE-mark approval in Europe. Bioheart said it plans to begin commercial distribution immediately.
"What you have is a patient population that really is ill and they do go home and they live their lives and things happen to the patient and oftentimes they go to the emergency room because it's an onset of something," Marty Schildhouse, a spokesman for Bioheart, told Medical Device Daily. "Daily monitoring allows for that constant awareness of any potential changes."
The compact Bioheart 3370 heart failure monitor engages patients through personalized daily interactions and questions, while collecting vital signs and transmitting the information directly into a database. It is available in both a wireless configuration and through hook-up to regular telephone lines, the company said. A remotely located medical professional regularly monitors the data for any abnormal readings that may signal a change in the patient's health status. These changes are reported back to the treating physician.
"Remote monitoring of heart failure patients forms a cornerstone of heart failure disease management, enhancing the opportunity to avoid episodes of worsening heart failure and emergency hospitalizations," said William Abraham, MD, a professor of internal medicine and director of the division of cardiovascular medicine at Ohio State University Medical Center (Columbus). "In the long run, our goal is to improve quality of life and keep patients out of the hospital."
Cybernet Medical (Ann Arbor, Michigan), Biotronik (Berlin), Medtronic (Minneapolis), Boston Scientific (Natick, Massachusetts) and St. Jude Medical (St. Paul, Minnesota) also offer remote monitoring devices for heart patients, though most of these companies' devices are designed for patients with implanted cardiac devices, such as a pacemaker or defibrillator.
The Bioheart 3370 heart failure monitor collects data from a range of vital sign monitoring devices, a weight scale and a voice-activated heart failure status questionnaire, and provides for secure data transmission to an HTTP server on the Internet, the company noted.
"We are very excited about this tremendous opportunity to better serve the congestive heart failure patient population and their physicians," said Howard Leonhardt, Bioheart's CEO and chief technology officer. "This technology is highly synergistic to our work with MyoCell Therapy, an investigational cell therapy for the potential treatment of chronic heart damage, and marks the beginning of our ability to offer new intelligent devices that complement cell transplantation."
On average, Class III heart failure patients are hospitalized on an emergency basis six days of every six months, according to Bioheart. One of the goals of both MyoCell Therapy and the Bioheart 3370 monitor is to significantly reduce the number of emergency hospitalization days, as well as their associated costs, the company said.
"The Bioheart 3370 heart failure monitor is extremely simple and intuitive to use for elderly patients," said Bjarne Flou, CEO of RTX Healthcare. "We believe this partnership will deliver excellent value for patients and physicians."
The Bioheart 3370 monitor will be available through physician prescription.
"This product is going to be good for the patient, it's going to be good for the physician, and it also should be good for our healthcare system because it will help avoid visits to the emergency room," Schildhouse told MDD.
Bioheart delivers devices and biologics designed to help monitor, diagnose and treat heart failure and other cardiovascular diseases.