Business, cardiology

St Jude Medical gains European approval for heart failure devices

15 May 2007

St. Paul, Minn., USA. St. Jude Medical, Inc. (NYSE:STJ) has gained European CE Mark approval for its first wireless devices to treat patients with heart failure and with potentially lethal heart arrhythmias.

The Promote RF CRT-D (cardiac resynchronization therapy defibrillator) and Current RF ICD (implantable cardioverter defibrillator) feature radiofrequency (RF) telemetry for wireless 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. 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.

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 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.

“With wireless capability, physicians can quickly and securely implant devices without the need for a wand in the sterile field,” said Michael J. Coyle, president of St. Jude Medical’s Cardiac Rhythm Management Division. “This adds speed, efficiency and convenience to the implant procedure and follow-up visits.”

The Promote RF CRT-D and Current RF ICD 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.

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.

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