EU Green Lights SJM’s Newest ICDs

St. Jude Medical has announced that European Union regulators have given CE Mark of approval to market the company’s two latest implantable cardiac defibrillators.
From the press release:

The St. Jude Medical Accel family of ICD devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient’s 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 St. Jude Medical Accel family of ICDs, automatic threshold management is available on all leads for the first time.
The St. Jude Medical Accel family of ICD devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient’s 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 St. Jude Medical Accel family of 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 heart’s upper chambers (atria), the devices also include a new AT/AF Alert feature. This feature is designed to notify physicians when a rapid atrial rate (atrial tachycardia/atrial fibrillation [AT/AF]) 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 Merlin.net™ Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias, such as AF, with appropriate medication or ablation.
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 ischemia (which occurs when blood flow/oxygen to the heart muscle is obstructed). With the ST Monitoring diagnostic algorithm, 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 Merlin.net 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 (ECG). This can add important and never-before-available information to assist in medical decision making and accelerate patient care.

Press release: St. Jude Medical Announces European Approval of ICDs with Features That Automatically Enhance Patient Safety and Streamline Patient Follow-up …
Product pages: AnalyST Accel™ ICD; Current Accel …