St. Jude Medical is reporting that the FDA has approved the company’s two new defibrillators, Promote™ RF CRT-D (cardiac resynchronization therapy defibrillator) and Current™ RF ICD, both of which feature radiofrequency telemetry capabilities for remote device and patient monitoring. In many respects, these new devices from St. Jude seem to be going head to head against already approved ICDs from Medtronic, Concerto™ and Virtuoso™, reported by us last year.
From the press release:
RF telemetry enables secure, remote communication between the implanted device and the programmers in a clinician’s office or hospital. 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. Previously available in Europe, FDA approval brings this advanced technology to U.S. patients as well.
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 MICS technology also includes the capability to choose between 10 channels in order to optimize the telemetry link and avoid interference.
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 optimize the pacing performance of the device 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. It 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 devices feature the VIP(R) (Ventricular Intrinsic Preference) algorithm that 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.
Medical Connectivity Consulting has more thoughts about these devices…
Press release: St. Jude Medical Announces FDA Approval of Company’s First Radiofrequency Wireless ICD and CRT-D Heart Failure Devices …
