St. Jude Medical, Inc.
One Lillehei Plaza
St. Paul, Minnesota 55117
(651) 483.2000
www.sjm.com
Contacts: Angela Craig
Investor Relations
(651) 481-7789
Kathleen Janasz
Media Relations
(651) 415-7042
St. Jude Medical Announces FDA and CE Mark Approvals Of QuickOpt Timing Cycle
Optimization For Additional Heart Failure Devices
Approval provides timing-cycle optimization to more patients worldwide
ST. PAUL, Minn. -- June 28, 2007 -- St. Jude Medical, Inc. (NYSE: STJ) today announced U.S.
Food and Drug Administration (FDA) and European CE Mark 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. In about 90 seconds, the QuickOpt feature recommends to physicians which A-V
(atrial-ventricular) and V-V (ventricular-ventricular) timing values to use to program the devices.
This allows physicians to frequently optimize devices as their patients’ needs change over time.
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. 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.
“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, M.D., of Sansum
Clinic in Santa Barbara, Calif.
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.
“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, M.D., of
University Medical Center in 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. In addition to the Frontier II device, St. Jude Medical recently announced European
CE Mark approval of QuickOpt for the Zephyr™ pacemaker and 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 J. 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.”
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 forwardlooking 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 pages 13-20) and Quarterly Report
on Form 10-Q filed on May 9, 2007 (see pages 23-24). The Company does not intend to update
these statements and undertakes no duty to any person to provide any such update under any
circumstance.