FDA approves software upgrade to Boston Scientific's LATITUDE Patient Management system

May 12 2010

Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval for LATITUDE 6.0, a software upgrade to the Company's LATITUDE^® Patient Management system.  The LATITUDE system enables physicians to remotely monitor patients with implantable cardiac devices.  The upgrade provides enhanced functionality, including the ability to view an expanded history of a patient's remote follow-up data.

The LATITUDE Patient Management system can detect changes in a patient's heart health status between scheduled follow-up visits and send relevant data and alerts directly to physicians.  More than 160,000 patients have been enrolled on the system at more than 2,300 clinics across the U.S.  The LATITUDE system is available in 15 other countries and use of the system continues to expand internationally with nearly 1,700 patients enrolled in Europe at approximately 150 clinics.

In 2009, the LATITUDE system detected more than 7,000 patients with at least one event of atrial arrhythmia.  Patients with atrial arrhythmias such as atrial fibrillation, particularly those with heart failure, are at increased risk of stroke.  By identifying atrial arrhythmias earlier, physicians have the opportunity to intervene with treatments that may reduce patient risks.  

"Remote monitoring between regularly scheduled follow-up visits allows earlier observation of events, giving physicians the option to intervene earlier," said Kenneth Stein, M.D., Chief Medical Officer, CRM, for Boston Scientific's Cardiology, Rhythm and Vascular Group.  "We welcome FDA approval of LATITUDE 6.0, which offers software improvements in response to physician feedback."

The LATITUDE Patient Management system will be demonstrated at Boston Scientific's booth (#1017) during the 31st Annual Scientific Sessions of the Heart Rhythm Society, May 13 - 15 in Denver.

SOURCE Boston Scientific Corporation