St Jude Medical’s implantable defibrillators receive CE mark


St Jude Medical announced on 20 April 2009 CE mark approval of its AnalyST Accel and Current Accel implantable cardioverter defibrillators (ICDs), which automatically adjust therapy to changing patient needs for increased safety and accelerated follow-up.

The Accel family of ICD devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the heart, which helps to ensure that adequate therapy is consistently administered while conserving battery life. The devices do this by measuring the heart’s reaction to electrical stimulation from the device and confirming that the heart is responding to the stimulation. This AutoCapture Pacing System feature provides the dual benefit of added safety for the patient and added efficiency for physicians, as vital threshold tests are performed automatically and results are available to the physician for review on demand during follow-up via a simple device interrogation. In the Accel ICDs, automatic threshold management is available on all leads for the first time.

To better assist physicians in accurately diagnosing and managing patients with fast rates in the atria, the devices also include a new atrial tachycardia/atrial fibrillation (AT/AF) alert feature. This feature is designed to notify physicians when a rapid atrial rate exceeds a programmed value or occurs over an extended time period. The devices can be programmed to notify the patient through a unique vibratory alert that has been proven more effective than audible alerts. Additionally, the devices have the ability to inform the patient’s clinic through the St Jude Medical Merlin@home transmitter and Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias with appropriate medication or ablation.

“This family of devices enables me to streamline patient follow-up, allowing me to better manage therapy,” said Johannes Sperzel, Kerckhoff-Klinik in Bad Nauheim, Germany. “The fact that these tests are performed and thresholds are adjusted automatically means that I can quickly assess the results and then focus on other matters that concern the patient.”

In addition, the AnalyST Accel ICD includes the company’s proprietary ST Monitoring diagnostic algorithm, which continuously monitors specific changes in the heart’s electrical system. These changes can indicate conditions such as ischaemia. Small changes in the ST segment are continuously recorded and plotted; the information can then be retrieved by the physician via the Merlin Patient Care System during in-office follow-up. Alerts can also be configured so information about ST segment changes is sent directly to the physician through DirectAlerts notification, available with the PCN and the Merlin@home patient transmitter. Because many cardiac episodes are transient in nature, the continuous ST Monitoring capability available in the AnalyST Accel ICD gives physicians more comprehensive information over time compared to the standard electrocardiogram. This can add important and never-before-available information to assist in medical decision making and accelerate patient care.