St. Jude Medical (St. Paul, Minnesota) on Friday 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.
Because heart disease is different for each patient, customizing device settings for each patient — called optimization — enhances device performance so that it works in the most efficient manner possible. However, few patients currently receive the full benefit of their devices because echocardiography — the current gold standard — can be expensive and time-consuming.
QuickOpt Optimization produces results clinically-proven to be comparable to echocardiography, but is significantly less costly and time-consuming, according to St. Jude. A typical echo procedure takes between 30 and 120 minutes and requires interpretation by a technician, whereas QuickOpt Optimization is performed during patients’ regularly scheduled follow-up visits in about 90 seconds.
“This makes the benefits of QuickOpt available for an entirely new population of patients,” Kathleen Janasz, a spokesperson for St. Jude Medical, told Medical Device Daily.
In May the company reported approval of its newest pacemaker family, the Zephyr, which was the first pacemaker to feature QuickOpt (Medical Device Daily, May 4, 2007).
“We’ve found that physicians are enthused about QuickOpt,” Janasz said. “We’ve really had an overwhelmingly positive response because QuickOpt allows them to optimize a device for individual patient needs.”
As Janasz told MDD in May, devices come with default settings.
“Well, we’re all different,” she said. “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.
“With the expansion of QuickOpt Timing Cycle Optimization to CRT-P devices, I can now offer the benefits of V-V timing optimization to all of my heart failure patients, including those implanted with devices prior to the availability of the QuickOpt feature,” said Claudio Bonometti, MD, of Sansum Clinic (Santa Barbara, California).
“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.”
The QuickOpt feature was validated in a clinical trial using implantable cardioverter defibrillator (ICD) and CRT-D patients and is now available from St. Jude Medical in applicable device segments, the company said. In addition to the Frontier II device, St. Jude Medical recently reported FDA and CE Mark approval of the Promote and Current ICD families with QuickOpt capabilities.
“Based on overwhelming customer acceptance of the QuickOpt feature, it will now be available in more of our devices,” said Michael Coyle, president of St. Jude Medical’s Cardiac Rhythm Management Division. “Having QuickOpt available in so many of our device families means that more St. Jude Medical patients than ever have access to the benefits of easy, practical and effective optimization.”
Cardiac rhythm management is one of five major focus areas for St. Jude Medical, the company said. Its other focus areas include: atrial fibrillation, cardiac surgery, cardiology and neuromodulation.
Other major players in the CRM sector include Medtronic (Minneapolis) and Guidant (Indianapolis).
In April during a conference call hosted by Rick Wise, med-tech analyst for Bear Stearn, regarding the CRM market, Kenneth Ellenbogen, MD, an electrophysicologist in Richmond, Virginia, told listeners that St. Jude’s CRM market share has grown over the past three years from 7% to about 16% or 17% and that the company is on the verge of introducing 20 to 30 new products in the next couple of years (MDD, April 26, 2007).