Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA Regulatory

 News Release - May 3, 2007

St. Jude Medical Announces U.S. And European Approvals of Zephyr Pacemaker Family of Devices

New pacemakers save clinic time by automatically performing follow-up tests prior to office visits, and by bringing time-saving optimization to pacing

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced receipt of U.S. Food and Drug Administration (FDA) and European CE Mark approvals of its newest pacemaker family, and the first implants of the devices. The Zephyr(TM) pacemaker is designed to save valuable clinic time by automatically performing all standard follow-up testing before the patient arrives in the clinic. Zephyr also is the first pacemaker that can, in about 90 seconds, tell physicians which device timing settings are optimal for each patient's needs.

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 AV (atrial-ventricular) timing so it delivers optimal therapy to patients. QuickOpt(TM) Timing Cycle Optimization produces results clinically-proven to be comparable to echocardiography (or echo, the current industry standard), but is significantly less costly and time consuming. 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.

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 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, M.D., chief of the EP Lab at the Cardiocentro Ticino in 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.

"Zephyr pacemakers offer built-in disease management options that result in better patient care in less time," said Professor Tiziano Moccetti, M.D., chief of the Cardiocentro Ticino in Lugano, Switzerland, 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."

The Zephyr family features additional capabilities for saving time and providing individualized care for patients, including:
  • ACap(TM) 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(TM) 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 percent 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. This offers the opportunity for patients with all lead types to benefit from this proven safety feature.
"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 Dr. Raymond Schaerf, M.D., chief of Cardiothoracic Surgery at Providence St. Joseph's Medical Center in Burbank, Calif., 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 J. 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."

Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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