St. Jude Medical (St. Paul) in early May reported FDA and CE-marking approvals for its newest pacemaker family and first implants of the devices. The company said that the Zephyr pacemaker is designed to save clinic time by automatically performing all follow-up testing before the patient arrives in the clinic.
It said that Zephyr also is the first pacemaker that can, in about 90 seconds, tell physicians which device timing settings are optimal for each patient.
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 atrial-ventricular (AV) timing so it delivers optimal therapy to patients. QuickOpt Timing Cycle Optimization produces results "clinically-proven," the company said, to be comparable to echocardiography or echo, but at less cost and less time consumed. "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," the company said in a statement.
QuickOpt Timing Cycle Optimization was validated in a trial using implantable cardioverter defibrillator (ICD) patients and is available on all current St. Jude ICDs. The QuickOpt feature is only available on Zephyr pacemakers approved in Europe.
"In about 90 seconds, the QuickOpt feature allows us to effectively optimize the AV delay in every pacemaker patient, without requiring extensive echo or other cumbersome optimization method," said Professor Angelo Auricchio, MD, chief of the EP Lab at the Cardiocentro Ticino in Lugano (Lugano, Switzerland). "The combination of the QuickOpt feature and the VIP feature, which reduces unnecessary ventricular pacing, makes the Zephyr device beneficial for all pacemaker patients."
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.
Professor Tiziano Moccetti, MD, chief of the Cardiocentro Ticino in Lugano, who performed the first implant of the Zephyr DR pacemaker in Europe, said, "Zephyr pacemakers allow me to quickly optimize therapy for all of my patients individually, which is beneficial to patients and physicians alike."
Other features of Zephyr include: ACap Confirm feature, which periodically verifies the amount of energy needed for the atria to respond to stimulation pulses emitted by the pacemaker; based on the results of this periodic check, automatic self-adjustment of the energy output; enhanced Ventricular AutoCapture pacing system which, with each heartbeat, verifies how the heart's lower chambers are responding to the pacemaker's stimulation, and then makes automatic adjustments; a higher output backup safety pulse to ensure 100% pacing; compatibility with unipolar leads, in addition to standard bipolar leads capability.
Michael Coyle, president of St. Jude's Cardiac Rhythm Management Division. "With follow-up testing completed prior to patients arriving at the clinic, and with easy-to-use intuitive diagnostics at the clinic, Zephyr pacemakers eliminate some of the waiting and 'down time' during follow-ups, without compromising care."