Thursday, October 16, 2008

FDA Approves Device

St. Jude Medical has announced that FDA has cleared their implantable device SJM Confirm ™ implantable cardiac monitor (ICM). The monitor was designed to help physicians detect abnormal heart rhythms in patients with unexplained symptoms. The implantable monitor enables physicians to evaluate heart rhythm signals over a longer period of time using standard monitoring tests. In addition, the monitor was designed to help physicians diagnose and document difficult to detect rhythm disorders in patients who may suffer from unexplained symptoms, including syncope (the sudden and transient loss of consciousness), palpitations, and shortness of breath.

Syncope is responsible for about 3 percent of all emergency room visits and up to 6 percent of all hospitalizations. About 1 million people in the U.S. suffer from syncope, and finding the source of the unexplained syncope according to some physicians can be the most difficult diagnosis to make. Even after a physical examination and electrocardiogram evaluation through a monitor, approximately half of all cases of unexplained syncope go undiagnosed.

The monitor is about the size of a computer thumb drive and is the smallest implantable cardiac monitor available. It is implanted just under the skin which can be done in an outpatient setting under local anesthesia. Patients can remotely send data to their physicians when they are experiencing symptoms. The real time data helps physicians diagnose and treat the arrhythmias.

According to Eric S. Fain, M.D. President of the St. Jude Medical Cardiac Rhythm Management Division, “this implantable monitor enables patients to record data that coincides with their symptoms and then send the data to their physicians remotely for diagnosis to determine the best course of treatment for their arrhythmias.”