"St. Jude Medical" (St. Paul, Minnesota) said Thursday it has received FDA and European marketing approval of its newest pacemaker family, the Zephyr.

The Zephyr pacemaker is designed to save clinic time by automatically performing all standard follow-up testing before the patient arrives in the clinic, according to St. Jude.

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 also validate each test by viewing the associated stored electrograms, the company said.

Kathleen Janasz, a spokesperson for St. Jude Medical, told Medical Device Daily compared the technology to a school teacher getting students' tests back already graded.

Janasz said the Zephyr is the "first pacemaker anywhere" that can tell physicians in about 90 seconds which device timing settings are optimal for each patient's needs. This is achieved through an added feature called the QuickOpt Timing Cycle Optimization.

"This is designed to very quickly figure out 'what's the best setting for this patient'," Janasz said.

The Zephyr pacemaker is used to treat bradycardia, which is a heart rate that is too slow, Janasz said. The device monitors the heart and provides electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements.

While pacemakers come with default settings, Janasz explained, every patient is different and most people need their settings adjusted over time.

Until now, pacemaker patients who needed their device settings adjusted had to undergo an echocardiography (echo) procedure, the current industry standard, which typically takes between a half-hour to two hours and requires interpretation by a technician. So there is extra cost involved and extra time, Janasz added.

"Consequently, a lot of patients never have it done," Janasz said. "With QuickOpt the patient goes in, the physician pushes a button, and the performance settings show up on the screen."

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 company said. However, St. Jude added that 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 [atrial-ventricular (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 (Lugano, Switzerland). "The combination of the QuickOpt feature and the [Ventricular Intrinsic Preference (VIP)] feature, which reduces unnecessary ventricular pacing, makes the Zephyr device beneficial for all pacemaker patients."

The VIP algorithm is designed to allow the patient's own heart rhythm to prevail when possible, the company said. 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, according to St. Jude.

"Zephyr pacemakers offer built-in disease management options that result in better patient care in less time," said Professor Tiziano Moccetti, MD, chief of the Cardiocentro Ticino who performed the first implant of the Zephyr DR pacemaker in Europe. "Zephyr pacemakers allow me to quickly optimize therapy for all of my patients individually, which is beneficial to patients and physicians alike."

According to St. Jude, 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% 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.

"With the ACap Confirm and the enhanced Ventricular AutoCapture patient safety features turned on, my patients are assured of appropriate pacing without unnecessary battery drain. With both features turned on, the extended longevity Zephyr device displayed an expected 14-year lifespan," said Raymond Schaerf, MD, chief of Cardiothoracic Surgery at Providence St. Joseph's Medical Center (Burbank, California) and the first to implant a Zephyr XL DR device in the U.S. "The extended longevity assures my patients of a longer-lasting device with very advanced features and, in turn, fewer replacement surgeries, which combats their main concern upon receiving a pacemaker."

"Clinic time is a valuable commodity, and the Zephyr pacemakers help physicians and patients maximize their time together during follow-up visits," said Michael Coyle, president of St. Jude Medical'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."

The cardiac rhythm management market is one of five major focus areas for St. Jude Medical, according to the company.

Other major players in the CRM sector include Medtronic (Minneapolis) and Guidant (Indianapolis).

Last month 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 (Medical Device Daily, April 26, 2007).