Healthcare Industry News: cardiac resynchronization therapy
News Release - May 9, 2007
St. Jude Medical Announces FDA Approvals of Current ICD and Promote CRT-D Heart Failure Devices
First Devices Built on Company's New Consolidated PlatformST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of its newest devices for treating patients with potentially lethal heart arrhythmias and heart failure. The Current(TM) ICD (implantable cardioverter defibrillator) and Promote(TM) CRT-D (cardiac resynchronization therapy defibrillator) are St. Jude Medical's first devices to be built on the company's new consolidated hardware and software platform to support implantable cardiac devices.
The next generation "Unity" device platform will enable St. Jude Medical to more quickly update all devices with new features and diagnostics, as they become available, because the basic framework for all of the devices will be the same. In addition, the consolidated platform's expanded capabilities can support, in the future, more advanced algorithms and features for better patient management. Furthermore, programming during device follow-up will be streamlined, as all software interfaces for new St. Jude Medical pacemakers, ICDs and CRT devices and most nominal settings will be the same.
The Promote CRT-D offers flexibility in pacing choices by allowing physicians to select an additional LV lead pacing pulse configuration. (A lead is a thin, insulated wire, connected to the heart tissue on one end and to the device on the other end. It transmits electrical impulses to the heart, and information from the heart back to the implanted device, so physicians can use it for diagnoses. LV leads are placed in the lower left chamber of the heart.) This flexibility of allowing selection of the LV pacing configuration provides for more options to allow for optimizing pacing without the need to manually reposition the lead.
In addition, the VIP® (Ventricular Intrinsic Preference) algorithm (currently available in St. Jude Medical's Victory® and Zephyr(TM) pacemakers) is now available in the Current ICD and provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient's own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients' overall heart health. Both devices also feature new patient management tools, such as enhanced patient exercise monitoring that gives the physician information about patient activity levels. Improved lead monitoring capabilities--including adding daily checks of each shock vector to those performed for pacing vectors --provide added patient safety.
In addition to new parameters and diagnostics, the Current ICD and Promote CRT-D include these proprietary technologies available in previous St. Jude Medical high-voltage devices:
- QuickOpt(TM) Timing Cycle Optimization - A programmer-based optimization method for people with CRT-Ds and ICDs that helps physicians quickly program the device's timing cycles - in about 90 seconds - 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(TM) technology - which is designed to help devices meet the needs of patients with high or varying defibrillation thresholds.
- SenseAbility(TM) technology - which is designed to optimize sensing to help protect against inappropriate shocks.
- Vibrating patient notifier - The industry's only notifier that gently vibrates to notify patients of critical changes in device performance instead of issuing the standard audio alert; this can be especially beneficial for people with hearing loss.
"Our newest devices build upon the strengths of previous devices by offering tailored therapy, crucial diagnostic information and additional safety," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "They exemplify our commitment to providing high-quality products for physicians and patients."
The Current ICD and the Promote CRT-D are two of more than 20 new cardiac rhythm management products being introduced this year by St. Jude Medical. The wireless versions of the Current ICD and the Promote CRT-D devices (with radiofrequency telemetry) have just received European CE Mark approval. RF telemetry enables secure, remote communication between the implanted device and the programmers in a clinician's office. Wireless communication occurs while the device is being implanted and when patients see physicians for follow-up visits, allowing for safer, more convenient care and device management. The feature is currently under review and is pending U.S. regulatory approval.
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). Nearly 1,000 people every day and more than 350,000 every year in the U.S. die from SCD. An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.
cardiac resynchronization therapy - delivered in an ICD or a pacemaker - 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. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. 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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). 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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