Biotronik's new Lumax ICD with telemonitoring of heart and device

3 October 2006

Berlin, Germany. BIOTRONIK’s new Lumax implantable cardioverter defibrillator (ICD) contains not only a defibrillator that can deliver life-saving electric shocks to the heart, but also integrates a technology that monitors the functions of both the heart and the device itself. The company claims that this double capability is unique in the world.

The new Lumax ICD automatically transfers all important diagnostic data to the cardiologist over a mobile phone network — once a day, and immediately in the case of a critical event. The physician just needs to log in through a secure Internet site to be informed of the patient’s current cardiac status. Moreover, the home monitoring technology automatically sends a SMS, email or fax to the physician in case of a critical change in the patient’s heart rhythm.

A high-definition intracardiac ECG sent over the GPRS network enables the physician to detect atrial fibrillation in time.
In most cases, the patient does not notice this heart rhythm disorder, but repeated atrial fibrillation may result in a stroke, or lead to heart failure. “Most of the time, the patient is not aware that he or she has atrial fibrillation,” says Dr Leal of the Hospital Universitario de Valme in Seville. “Automatic transfer of the ECG data opens up new possibilities for the diagnosis of atrial fibrillation. We are immediately informed on the disorder, and do not wait until the next routine check-up to initiate the appropriate therapy,” Dr Leal further says.

As an additional feature, the new Lumax ICD also detects possible technical malfunctions in the device, such as a decreasing signal quality that could impair the precision of future therapies. The physician can clearly distinguish interfering signals from cardiac events on a computer and contact the patient for correction of the technical problem.

The new home monitoring technology facilitates patient follow up, as remote diagnosis enables physicians to be continuously informed on their patients’ health status. In case of any rhythm disorder in either the atrium or the ventricle, the integrated GPRS technology automatically sends ECGs of both chambers to BIOTRONIK’s service center. The physician’s monitor can display more than 30 seconds of IEGM Online. The intracardiac ECG reflects both the onset time (period before the rhythm disorder) and the phase after termination of the event, thus considerably improving the physician’s diagnostic scope. Moreover, the cardiologist may analyze the ICD’s programming at any time using the Internet.

Many patients compare the electric shock that saved their life in case of cardiac arrest with a kick from a horse. Indeed, such shocks are very painful and directly impair the patients’ quality of life. Moreover, they stress the heart muscle and reduce the ICD’s longevity.

The Lumax ICD, however, delivers a pain-free and energy-saving therapy in a first stage. In order to stabilize the heart rhythm, the new technology generates a rapid sequence of considerably lower electric pulses that the patient does not even notice. If the initial therapy remains unsuccessful, the device delivers high-energy, painful, but life-saving defibrillation in a second stage.

BIOTRONIK’s ATP One-shot technology can avoid defibrillation in three out of four cases. Dr Med Schwab of Bonn’s University Hospital, who is in charge with the first implantation of Lumax ICDs, stated: “Thanks to ATP One-shot, the Lumax terminates live-threatening heart rhythm disorders rapidly and painlessly, thus considerably improving the patients’ quality of life. Moreover, the device can avoid hospitalization, as the patients are no longer calling their physicians because of their anxiety following the electrical shock. Another asset of this technology is the considerable improvement of the ICDs’ service time as a result of the reduced number of electric shocks.”

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