Healthcare Industry News:  neuromodulation 

Devices Monitoring Cardiology Regulatory

 News Release - October 14, 2008

St. Jude Medical Announces European CE Mark Approval of Implantable Device for the Detection of Atrial Fibrillation and Other Abnormal Heart Rhythms

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced it has received approval for European CE Marking of its SJM Confirm™ implantable cardiac monitor (ICM), a compact device designed to detect atrial fibrillation (AF) and other abnormal heart rhythms.

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. The device features a St. Jude Medical sensing algorithm which is designed to aid in better signal detection, thus enabling physicians to program the monitor to better sense 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 designed to provide better contact with the subcutaneous tissue for more accurate sensing of cardiac signals.

“The SJM Confirm implantable cardiac monitor will help me to accurately detect and record the cardiac rhythm events associated with syncope and other arrhythmias, as these can be difficult to distinguish with other diagnostic methods,” said T. Lewalter, M.D., from St. Vincenz – Krankenhaus, in Paderborn, Germany. “Furthermore, I am looking forward to evaluating the algorithm capabilities of the SJM Confirm ICM to monitor my patients’ hearts after AF ablation. It should allow me to detect if the arrhythmia comes back or if another one starts.”

AF is responsible for 15 to 20 percent of all strokes, is a contributor to heart failure and is a leading cause of hospitalizations. Many millions of people worldwide suffer from AF, with about one-third experiencing asymptomatic, or “silent” AF.1 Other patients experience paroxysmal AF (AF that starts suddenly and may last a few seconds, minutes or hours before spontaneously stopping). These patients represent a particular diagnostic challenge as they are likely to experience asymptomatic arrhythmia events up to 12 times more frequently than symptomatic arrhythmia events and are often unaware that AF is occurring. It is estimated that one in four patients with paroxysmal AF will develop some sort of persistent AF. 2

Similarly, many patients suffer from unexplained syncope (fainting), the source of which, according to some physicians, is the hardest diagnosis to make. In fact, even after a physical examination and ECG evaluation through a Holter monitor, approximately half of all cases of unexplained syncope go undiagnosed.

"We developed the SJM Confirm ICM to provide physicians with more accurate and more comprehensive data about their patients’ hearts, particularly those patients who are the most challenging to diagnose,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “This implantable monitor has the added capability to send stored electrocardiogram data over the telephone line that provides physicians a more continuous view of what’s happening with patients between office visits. The monitor also allows patients to control the data being recorded at times when they are symptomatic, thereby assisting physicians to have precise heart rhythm monitoring information to aid them in determining the best course of treatment.”

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 was first 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, enabling 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 Europe this month.

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 13,000 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.

1 Source: National Heart Lung and Blood Institute, 2005; US Census Bureau, Population Estimates and International data base, 2004; JAMA 2001

2 Ruigomez, S. Johansson and M.A. Wallander et al., Predictors and prognosis of paroxysmal atrial fibrillation in general practice in the UK, BMC Cardiovasc Disord 5 (2005), p. 20.


Source: St. Jude Medical

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