Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - May 13, 2009

St. Jude Medical Announces European Approval of Accent RF and Anthem RF Pacemakers Equipped With Wireless Technology

Product represents important next step in health care connectivity for pacemaker patients with the introduction of the first devices with automatic test results and complete diagnostics that can be accessed via wireless communication in a clinic or remotely

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its Accent™ RF pacemaker and Anthem™ RF CRT-P (cardiac resynchronization therapy pacemaker).

The Accent and Anthem product family features RF telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician, making it the first integrated system of pacing devices with wireless telemetry from implant through follow-up. Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or via remote monitoring with the patient at home, allowing for more efficient and convenient care and device management.

“The introduction of the Accent RF and Anthem RF products represents the next step taken by St. Jude Medical in health care connectivity involving implantable devices,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “We designed the pacemakers in response to the physician and patient needs for intelligent products that streamline testing and follow-up, as well as to facilitate an exchange of information between the physician and patient. Using the remote monitoring capabilities, physicians will be able to stay abreast of device function and the patient’s condition, enabling a more timely response to the patient’s evolving needs.”

The remote monitoring capabilities facilitated by the Accent RF and Anthem RF device product line will permit automated follow-up, and daily device safety checks with no patient action required. In addition to giving physicians fast access to device performance data, the wireless monitoring system will also allow physicians to compile a more complete patient record by easily transferring cardiac device data into electronic health records (EHRs).

“Device implants and follow-ups are performed more quickly and easily with the wireless technology available in these devices,” said Johannes Sperzel M.D., from Kerckhoff Klinik in Bad Nauheim, Germany.

To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the devices will 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 also can be programmed to notify the patient of AT/AF episodes, as well as device- and lead-related issues, through a two-tone audible alert. In addition, the patient’s clinic can be informed through the home monitoring system. These features will allow the physician to more proactively manage patients’ atrial arrhythmias, such as AF, with appropriate medication or ablation.

“The wireless communication automates patient home monitoring, as no patient interaction is required for data transmission. Diagnostic data and alerts can be transmitted automatically to the clinic, providing me with more timely notification of clinical events and better patient care,” said Professor Karlheinz Seidl, M.D., from Klinikum der Stadt Ludwigshafen, in Ludwigshafen, Germany.

In addition, the Anthem RF CRT-P and Accent RF pacemaker include advanced automatic features that help to promote patient safety and efficiency for the clinician. The devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient’s heart, in the chambers where therapy is delivered; this includes up to three chambers for cardiac resynchronization therapy. 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 increased 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. The launch of the Accent RF and Anthem RF devices marks the first time that these automatic test results can be accessed remotely or wirelessly in a clinic for a complete pacemaker family, including a CRT-P, and single- and dual-chamber models.

The devices are also equipped with the St. Jude Medical QuickOpt® Timing Cycle Optimization feature. QuickOpt Timing Cycle Optimization can recommend the optimal A-V (atrial-ventricular) and/or V-V (ventricular-ventricular) timing values, depending upon device model, to use in programming the devices. Optimized timing can increase the efficiency of the heart’s ability to pump blood to the body. Traditional echocardiography (echo), while considered the gold standard for optimizing devices, is expensive and time-consuming. QuickOpt Timing Cycle Optimization produces results clinically proven to be comparable with those of echo, in 90 seconds instead of the 30 to 120 minutes required for a typical echo.

Additionally, the Accent RF pacemaker features the St. Jude Medical Ventricular Intrinsic Preference (VIP®) algorithm, with which the device monitors the heart beat-by-beat and provides pacing only when necessary. Allowing the patient’s natural heart rhythm to work on its own when possible has been shown to benefit overall heart health.

Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements.

A CRT-P resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. An estimated 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed each year.

The Merlin.net™ Patient Care Network version 4.0, which will support the Accent RF and Anthem RF remote monitoring capabilities, is expected to be approved by mid-summer.

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 four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 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.


Source: St. Jude Medical

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