Healthcare Industry News:  neuromodulation 

Devices Monitoring Cardiology FDA

 News Release - September 11, 2008

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

New monitor helps physicians detect abnormal heart rhythms in patients with unexplained symptoms

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance of 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 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, 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.

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, approximately half of all cases of unexplained syncope go undiagnosed.

"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.”

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 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
  • Three year device longevity
  • Compatibility with the St. Jude Medical® Merlin® Patient Care System, a powerful, portable computer designed to help physicians access and analyze diagnostic information and print full-size comprehensive data reports
  • Remote monitoring that allows patients to send data directly to their physicians
The SJM Confirm ICM will be launched in October 2008.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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