Newly approved by the FDA and EU bureaucrats (CE Mark) is the new line of pacemakers from St. Jude Medical.
From yesterday’s press release:
St. Jude Medical, Inc. today announced receipt of U.S. Food and Drug Administration (FDA) and European CE Mark approvals of its newest pacemaker family, and the first implants of the devices. The Zephyr™ pacemaker is designed to save valuable clinic time by automatically performing all standard follow-up testing before the patient arrives in the clinic. Zephyr also is the first pacemaker that can, in about 90 seconds, tell physicians which device timing settings are optimal for each patient’s needs.
When a Zephyr device is interrogated during a follow-up visit, the stored diagnostics, trends and measurements from the automatic tests are displayed for evaluation. Physicians can validate each test by viewing the associated stored electrograms.
In about 90 seconds, physicians also can quickly program the device’s AV (atrial-ventricular) timing so it delivers optimal therapy to patients. QuickOpt™ Timing Cycle Optimization produces results clinically-proven to be comparable to echocardiography (or echo, the current industry standard), but is significantly less costly and time consuming. A typical echo procedure takes between 30 and 120 minutes and requires interpretation by a technician, whereas QuickOpt Optimization allows for frequent optimizations for patients as their needs change.
QuickOpt Timing Cycle Optimization was validated in a clinical trial using implantable cardioverter defibrillator (ICD) patients and is also available on all current St. Jude Medical ICDs. (The QuickOpt feature is only available on Zephyr pacemakers approved in Europe…)
The VIP® (Ventricular Intrinsic Preference) algorithm 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…
The Zephyr family features additional capabilities for saving time and providing individualized care for patients, including:
ACap™ Confirm feature, which periodically verifies the amount of energy needed for the upper chambers of the heart (atria) to respond to stimulation pulses emitted by the pacemaker. (The heart’s response to a stimulation pulse is called capture.) Based on the results of this periodic check, the device automatically self-adjusts the energy output required. Enhanced Ventricular AutoCapture™ pacing system which, with every heartbeat, verifies how the heart’s lower chambers are responding to the pacemaker’s stimulation, and then automatically adjusts based on that information. To ensure effective pacing 100 percent of the time, a higher output backup safety pulse is available. The enhanced Ventricular AutoCapture pacing system now provides compatibility with unipolar leads, in addition to the standard bipolar leads capability. This offers the opportunity for patients with all lead types to benefit from this proven safety feature.
Products page: Zephyr™ Pacemakers
Press release: St. Jude Medical Announces U.S. And European Approvals of Zephyr Pacemaker Family of Devices …