FDA clears Sorin's SmartView, cardiac implantable device remote monitor

By Aditi Pai
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SmartViewThis week, Sorin Group announced that the FDA cleared SmartView, a remote monitoring application for patients with implanted cardiac rhythm management devices. The technology allows physicians whose patients have a Paradym device, Sorin Group's implantable cardioverter-defibrillator (ICD), to monitor them outside of the office.

SmartView is a home health hub that collects data wirelessly from the patient's implanted device. The data is then sent to a web application via a cellular network. Physicians can access the information in a PDF report available through the web application. The monitor also alerts physicians via text, fax or email and sends the information to a second physician if the alert remains unopened.

While SmartView just received clearance in the United States, the monitor launched in select European countries in June 2012 and Canada in December 2012.

Adding remote monitoring to these types of devices has proven to help patients in the past. In 2010, Executive Director of USC's Center for Body Computing Dr. Leslie Saxon completed a study of 100,000 patients with implanted heart devices that concluded patients with remote monitoring faced half the mortality rate than those that did not use wireless enabled tracking.

"A lot of naysayers have said they don’t want to use US healthcare dollars on these high tech devices in sick patients," Saxon said in an interview with MobiHealthNews at the time. "Over time it turns out to be very cost effective. It’s a good bet. That is important for patients with heart failure, because the incidence is rising. This is the first study to show this is a worthwhile and durable therapy from an economic standpoint."

Many other medical device companies have created remote monitoring systems similar to Sorin's SmartView. For example, in June 2011, Medtronic launched its first app for physicians that helps them monitor patients with implantable devices and later that year St. Jude added an alert system to its implantable device monitoring offering Merlin@home.