Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology Regulatory

 News Release - April 20, 2009

St. Jude Medical Announces European Approval of ICDs with Features That Automatically Enhance Patient Safety and Streamline Patient Follow-up

St. Jude Medical Accel family of devices provide new alerts and insight into cardiac conditions such as atrial fibrillation and ischemia

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its AnalyST Accel™ and Current Accel™ ICDs (implantable cardioverter defibrillators), which automatically adjust therapy to changing patient needs for increased safety and accelerated follow-up.

The St. Jude Medical Accel family of ICD devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient’s heart, which helps to ensure that adequate therapy is consistently administered while conserving battery life. The devices do this by measuring the heart’s reaction to electrical stimulation from the device and confirming that the heart is responding to the stimulation. This AutoCapture™ Pacing System feature provides the dual benefit of added safety for the patient and added efficiency for physicians, as vital threshold tests are performed automatically and results are available to the physician for review on demand during follow-up via a simple device interrogation. In the St. Jude Medical Accel family of ICDs, automatic threshold management is available on all leads for the first time.

To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the devices also include a new AT/AF Alert feature. This feature is designed to notify physicians when a rapid atrial rate (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a programmed value or occurs over an extended time period. The devices can be programmed to notify the patient through a unique vibratory alert that has been proven more effective than audible alerts.1 Additionally, the devices have the ability to inform the patient’s clinic through the St. Jude Medical Merlin@home™ transmitter and™ Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias, such as AF, with appropriate medication or ablation.

AF is the most common abnormal heart rhythm condition, affecting millions of patients worldwide. With AF, the heart’s upper chambers (the atria) do not beat effectively due to abnormal electrical activity. As a result, the heart cannot effectively pump blood, which can lead to shortness of breath, heart palpitations and fatigue. If left untreated, AF increases the risk of stroke five-fold, according to a study reported in the journal Stroke (Wolf et al., Atrial Fibrillation as an Independent Risk Factor for Stroke: the Framingham Study, 1991).

“This family of devices enables me to streamline patient follow-up, allowing me to better manage therapy,” said Johannes Sperzel, M.D., of the Kerckhoff-Klinik in Bad Nauheim, Germany. “The fact that these tests are performed and thresholds are adjusted automatically means that I can quickly assess the results and then focus on other matters that concern the patient.”

In addition, the AnalyST Accel ICD includes the company’s proprietary ST Monitoring diagnostic algorithm, which continuously monitors specific changes in the heart’s electrical system. These changes can indicate conditions such as ischemia (which occurs when blood flow/oxygen to the heart muscle is obstructed). With the ST Monitoring diagnostic algorithm, small changes in the ST segment are continuously recorded and plotted; the information can then be retrieved by the physician via the Merlin® Patient Care System during in-office follow-up. Alerts can also be configured so information about ST segment changes is sent directly to the physician through DirectAlerts® notification, available with the PCN and the Merlin@home patient transmitter. Because many cardiac episodes are transient in nature, the continuous ST Monitoring capability available in the AnalyST Accel ICD gives physicians more comprehensive information over time compared to the standard electrocardiogram (ECG). This can add important and never-before-available information to assist in medical decision making and accelerate patient care.

“Our goal in providing automaticity for vital tests is to enhance patient safety by providing physicians the tools to optimize therapy delivery,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “Because the tests are performed on an ongoing basis, adjustments can be made if necessary. Furthermore, the results and other patient information can be accessed in the office or over the telephone via remote monitoring, ensuring that access to information about the patient’s condition is readily available.”

The St. Jude Medical Accel family of products also includes other features available in the company’s ICDs, such as:

  • QuickOpt® Timing Cycle Optimization - A programmer-based optimization method for people with Cardiac Resynchronization Therapy defibrillators (CRT-Ds) and ICDs that helps physicians quickly - in less than 90 seconds - program a device's timing cycles to help deliver optimal therapy to patients. As demonstrated in clinical studies, the QuickOpt feature produces results that are comparable to echocardiography, the current gold standard, but is significantly less costly and time-consuming.
  • DeFT Response® technology - which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia.
  • SenseAbility® technology - which is designed to optimize sensing to help protect against inappropriate shocks.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.

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 approximately 14,000 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

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 for the fiscal year ended January 3, 2009. 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 Bennett MT et al. “The ICD patient alert is potentially an unreliable ICD warning feature.” Presented at the Canadian Cardiovascular Congress, Toronto, Ontario, October 26, 2008.

Source: St. Jude Medical

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