St. Jude Medical Gets FDA OK for Implantable Cardiac Monitor

PASADENA, Calif., Sep 22, 2008 (ASCRIBE NEWS via COMTEX) -- STJ | Quote | Chart | News | PowerRating -- St. Jude Medical has announced the U.S. Food and Drug Administration clearance of its SJM Confirm implantable cardiac monitor, a compact device designed to help physicians diagnose abnormal heart rhythms.

The implantable monitor enables physicians to evaluate heart rhythm signals over a longer period of time than allowed by standard monitoring tests, and is designed to help them diagnose and document difficult-to-detect rhythm disorders in patients who may suffer from unexplained symptoms, including syncope, palpitations and shortness of breath.

About the size of a computer thumb drive, the SJM Confirm ICM is the smallest implantable cardiac monitor available. It is implanted just under the skin in the upper chest region and can be implanted in an outpatient procedure under local anesthesia. Patients are able to remotely send data to their physicians when they experience symptoms. This real-time data helps physicians diagnose and treat the arrhythmias.

The SJM Confirm ICM features a St. Jude Medical sensing algorithm designed to enhance signal detection, thus enabling physicians to program the device to be more sensitive to small and wide-ranging signals. Electrodes on the monitor sense cardiac activity and a continuous loop recorder stores information about the heart's activity. The electrodes are positioned on opposite sides of the device; this design is intended to provide better contact with the subcutaneous tissue for more accurate sensing of cardiac signals.

"The SJM Confirm ICM was developed in response to physicians' need for more information about heart rhythm abnormalities, particularly in patients who are most challenging to diagnose," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "This implantable monitor enables patients to record data that coincide with their symptoms and then send that data to their physicians remotely for diagnosis and determination of the best course of treatment for their arrhythmias."

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