St. Jude Medical (St. Paul, Minnesota) in early July reported U.S. and European regulatory approvals to expand the capabilities of its Frontier II cardiac resynchronization therapy pacemaker (CRT-P) to include QuickOpt Timing Cycle Optimization, giving physicians a new option to manage therapy for patients based on their individual needs.
The Frontier II device is the first heart failure pacemaker with QuickOpt Timing Cycle Optimization, according to St. Jude. In about 90 seconds, the QuickOpt feature recommends to physicians which atrial-ventricular (A-V) and ventricular-ventricular V-V timing values to use to program the devices. This allows physicians to frequently optimize devices as their patients’ needs change over time, the company said.
Few patients currently receive the full benefit of their devices because adjustments made via the result of echocardiography are expensive and time-consuming, St. Jude said.
It said that QuickOpt produces results comparable to echocardiography, but is less costly and less time-consuming, a typical echo procedure taking 30 -120 minutes and requiring interpretation by a technician. QuickOpt Optimization takes about 90 seconds and so can be done during a regularly scheduled follow-up.
“This makes the benefits of QuickOpt available for an entirely new population of patients,” Kathleen Janasz, spokesperson for St. Jude, told Cardiovascular Device Update.
In May the company reported approval of its newest pacemaker family, the Zephyr, the first pacemaker to feature QuickOpt.
Janasz said physician response has been “overwhelmingly positive because QuickOpt allows them to optimize a device for individual patient needs.” She added: “We’re all unique individuals. For a device to work optimally it needs to be programmed to the specific needs of that patient.”
Prior to regulatory approval, QuickOpt Timing Cycle Optimization was technically available on the device, but “turned off” for previously implanted Frontier II devices. With approval, the feature will be enabled, making optimized therapy available to current and new St. Jude Medical patients alike, the company said.
“Now that the QuickOpt feature is available for the Frontier II CRT-P, I can provide timing cycle optimization to all my pacemaker, ICD and CRT patients,” said Mathias Meine, MD, of University Medical Center (Utrecht, the Netherlands). “This results in a significantly increased number of patients receiving the benefits of timing cycle optimization while improving clinic efficiency and follow-up time.”
QuickOpt feature was validated in a trial using implantable cardioverter defibrillator (ICD) and CRT-D patients. In addition to the Frontier II device, St. Jude recently reported FDA and CE-mark approval of the Promote and Current ICD families with QuickOpt capabilities.