A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported the FDA approval and market launch of its newest platform of pacemakers, the Victory family of devices. The product will be immediately available in the U.S. and Europe. The product family received the European CE mark last fall (Medical Device Daily, Nov. 1, 2005).
Among the important features included in Victory pacemakers are optimized settings designed to save time at implant, Ventricular Intrinsic Preference (VIP) technology designed to minimize ventricular pacing, and the FastPath summary screen expected to speed follow-up exams.
"The Victory pacemaker significantly reduced device set-up time at implant because it is pre-programmed with optimized settings that contribute to the efficiency and success of the procedure," said Raymond Schaerf, MD, chairman of the department of surgery and chief of thoracic surgery at Providence Saint Joseph Medical Center (Burbank, California), who performed the first U.S. implant of the Victory XL DR pacemaker.
The company said that physicians in Europe are already reporting the benefits of the device's advanced technology that is designed to reduce in-clinic follow-up time without compromising patient care.
"The ability of the Victory pacemaker to measure thresholds and intrinsic events and display those results with EGMs for quick verification means that 80% of standard follow-up testing is complete when the patient walks in the door," said Johannes Sperzel, MD, who performed the first patient follow-up at Kerckhoff Klinik Kardiologie (Bad Nauheim, Germany).
"We expect that physicians and patients will respond enthusiastically to the Victory pacemaker family because this next generation of devices combines the highest level of performance with important time-saving benefits," said Michael Coyle, president of St. Jude's Cardiac Rhythm Management division.
Engineered to anticipate a wide variety of the diagnostic and therapy needs of patients, Victory pacemakers (models 5810 and 5816) also offer a suite of algorithms designed to make it easier for physicians to manage patients with AF.
The new pacemaker family also introduces the VIP technology, an enhancement developed from clinical experience with the company's AutoIntrinsic Conduction Search feature. VIP technology is designed to promote more natural heart function and minimize ventricular pacing.
This is an important clinical consideration, the company said, because studies such as the St. Jude-sponsored DAVID (for Dual-Chamber And VVI Implantable Defibrillator) trial have shown that excessive ventricular pacing may contribute to heart failure in some patients. VIP technology is designed to allow the patient's own heartbeat to be "in control" most of the time.
Any necessary in-clinic testing can now be completed more rapidly than before with the FastPath summary screen, which provides pre-set test values and increases flexibility with multiple follow-up options, according to the company. It allows clinicians to spend more time with the patient and less time programming the device.