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St Jude Medical's new defibrillator models receive CE mark approval

St Jude Medical : 09 May, 2007  (New Product)
St Jude Medical has been granted 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 resynchronisation 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.

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 optimise the pacing performance 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.

The lead 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 VIP (Ventricular Intrinsic Preference) algorithm 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 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 Timing Cycle Optimization - A programmer based optimisation 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 optimisation guided by echocardiography, the current gold standard, but is significantly less costly and time consuming.

- DeFT Response technology - which is designed to help devices meet the needs of patients with high or varying defibrillation thresholds.

- SenseAbility technology - which is designed to optimise 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.

'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 (SCD).

Nearly 1,000 people every day and more than 350,000 every year in the USA 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 - resynchronises 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 five million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.
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