St. Jude Medical Receives FDA Clearance of Implantable Device to Monitor Cardiac Conditions


September 12, 2008

September 12, 2008 - St. Jude Medical Inc. yesterday said the FDA cleared its SJM Confirm implantable cardiac monitor (ICM), 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 (the sudden and transient loss of consciousness), palpitations and shortness of breath.

About the size of a computer thumb drive, the SJM Confirm ICM is said to be the smallest implantable cardiac monitor available. It is implanted just under the skin (subcutaneously) 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, 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, which is intended to provide better contact with the subcutaneous tissue for more accurate sensing of cardiac signals, the company said.

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 the source of unexplained syncope, according to some physicians, is the most difficult diagnosis to make. Even after a physical examination and electrocardiogram (ECG) evaluation through a Holter monitor, about half of all cases of unexplained syncope go undiagnosed.

The SJM Confirm ICM is the first implantable monitor to be built on a unified platform, which has enabled St. Jude Medical to more quickly introduce devices with new features and diagnostics (as they become available) because the basic platform for all of the devices is the same. The St. Jude Medical Unity device platform first was introduced in September 2007 with the launch of its Promote RF CRT-D and the Current RF ICD devices. Due to its uniform software interfaces and expanded features, the new platform gives physicians more choices during device programming and patient follow-up, the company said.

The SJM Confirm ICM also features programmable event triggers, which enable physicians to program the device to automatically capture and record up to 60 seconds before and after a cardiac event. The device has a three-year life span. It is compatible with the St. Jude Medical Merlin Patient Care System, a portable computer designed to help physicians access and analyze diagnostic information and print full-size comprehensive data reports. It also allows remote monitoring so patients can send data directly to their physicians.

The SJM Confirm ICM will be launched in October 2008, the company said.

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