St. Jude Medical Announces FDA Approval of Company's First Radiofrequency Wireless ICD and CRT-D Heart Failure Devices
St. Jude Medical today announced U.S. Food and Drug Administration (FDA) approval of its first radiofrequency (RF) wireless devices to treat patients with heart failure and with potentially lethal heart arrhythmias. The Promote(TM) RF CRT-D (cardiac resynchronization therapy defibrillator) and Current(TM) RF ICD (implantable cardioverter defibrillator) feature radiofrequency telemetry for wandless communication with programmers used by physicians to interrogate and program devices.
RF telemetry enables secure, remote communication between the implanted device and the programmers in a clinician's office or hospital. Wireless communication occurs while the device is being implanted and when patients see physicians for follow-up visits, allowing for efficient, more convenient care and device management. Previously available in Europe, FDA approval brings this advanced technology to U.S. patients as well.
The devices use a dedicated range of frequencies designated for medical devices called the MICS (Medical Implant Communications Service) frequency band, which helps to prevent interference from other electronic signals. The MICS technology also includes the capability to choose between 10 channels in order to optimize the telemetry link and avoid interference.
The Promote RF CRT-D and Current RF ICD are built on St. Jude Medical's next generation "Unity" device platform. This consolidated electronics platform will enable 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. In addition, the consolidated platform's expanded capabilities can support 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 will be the same.
The Promote RF CRT-D allows physicians to electronically reconfigure left ventricular (LV) leads to help optimize the pacing performance of the device without the need to physically reposition the lead. (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.)
In addition, the devices feature the VIP(R) (Ventricular Intrinsic Preference) algorithm that is designed to allow the patient's own heart rhythm to prevail when possible. VIP technology actively monitors the heart on a beat-by-beat basis to provide pacing 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 painless daily checks of all pacing and shock configurations - provide added patient safety.
The Promote RF CRT-D and Current RF ICD also include these proprietary technologies from St. Jude Medical:
-- QuickOpt(R) 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 optimization guided by 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.
"Wireless capability is beneficial to both patients and physicians because it further improves and simplifies device monitoring and management," said Eric S. Fain, president of St. Jude Medical's Cardiac Rhythm Management Division. "In addition, these devices introduce the new consolidated hardware and software platform, which will serve as a springboard for bringing future features and diagnostics to patients and physicians more quickly."
The Promote RF CRT-D and Current RF ICD devices are scheduled to be launched at the American Heart Association Scientific Session 2007, Nov. 4 - 7. These devices are two of more than 20 new cardiac rhythm management products being introduced this year by St. Jude Medical.
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 die every day and more than 350,000 die every year in the U.S. 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 approximately 12,000 people worldwide. For more information, please visit www.sjm.com.
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 pages 13-20) and Quarterly Report on Form 10-Q filed on August 9, 2007 (see pages 26-29). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.