Radiofrequency ICD and CRT from St. Jude Medical Employ Wireless
Two new devices for cardiology applications from St. Jude Medical, Incorporated received FDA marketing approval, both of which include radiofrequency wireless components. Approval in Europe was already received. The news was detailed in a press release.
The Promote RF CRT-D (cardiac resynchronization therapy defibrillator) and Current RF ICD (implantable cardioverter defibrillator) both include radiofrequency telemetry. Completion of the telemetry with radiofrequency is both secure and can be completed remotely by clinicians. This feature supports wandless communication for physicians as they use programmers to program and interrogate the implanted devices.
The range of frequencies incorporated in the device are within the dedicated range for medical devices, the Medical Implant Communication Service (MCIS) frequency band. Ten different channels are available for optimization of the link with telemetry. These factors limit the possibility of interference from other electronic based signals.
Integration of the wireless capabilities supports ease of device use for the clinicians. Wireless communication is completed both during implantation of the defibrillators and during routine follow-up. The products also include the Ventricular Intrinsic Preference (VIP) algorithm, which enables the device to use the patient’s own, normal heartbeat when appropriate. Pacing is only completed on an as needed basis while the device follows each beat of the heart.
Also integrated in the system is a feature that allows clinicians to gather information about patient activity levels, which includes patient exercise monitoring. The leads were improved to provide better monitoring. As well, the device checks itself every day to verify shock and pace components. All of these features improve patient safety.
St. Jude’s device platform, Unity, are both incorporated in the two new devices. Broad use of the single platform will support implementation of new features into existing products as features are developed by St. Jude. The capabilities of the system also allow for integration of new algorithms to further optimize patient management.
September 19, 2007 Related topics: Product Launches, Product Approval & Certification, Cardiology, Standardization