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.
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.”
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
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.