St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug
Administration (FDA) approval of its new tachycardia software for the
Merlin™ Patient Care
System, a state-of-the-art computer used to program and interrogate
cardiac rhythm management devices like pacemakers and implantable
cardioverter defibrillators (ICDs).
This software upgrade, which will be launched over the coming weeks,
extends the benefits of the previously released Merlin graphical user
interface to both St. Jude Medical pacemaker and ICD products. The
system, which supports current and previous generation devices, is one
of more than 20 new cardiac rhythm management products being introduced
by St. Jude Medical this year.
The Merlin Patient Care System, which received FDA approval in April
2006, is a programmer designed to help physicians more efficiently
conduct tests and analyze therapeutic and diagnostic data. This
powerful, portable computer helps physicians retrieve and analyze
patient information during routine pacemaker and ICD follow-up visits,
providing quality patient care. With the Merlin Patient Care System,
physicians can quickly and easily make changes to device therapy using
an LCD touch-screen.
The system’s streamlined workflow is designed
to increase productivity for physicians and clinic staff. With the
Merlin Patient Care System, patients can receive the same high standard
of care during follow-up visits that take significantly less time.
“The Merlin system has truly raised the bar in
helping me provide better care to my patients,”
said Joseph Dell’Orfano, M.D., Saint Francis
Hospital and Medical Center, Hartford, Conn. “This
new ICD software allows me to increase the efficiency of my clinic by
reducing patient follow-up time and simplifying training requirements
for my staff.”
The Merlin Patient Care System was designed with the help of clinicians
to better manage patients with pacemakers and ICDs. The system
represents an evolution in programmer technology and includes
easy-to-use graphical screens so clinicians can more efficiently assess
device function and care for their patients. With the new software, this
system provides physicians with a complete solution to St. Jude Medical
pacemaker and ICD follow-up visits.
“Physicians have responded enthusiastically to
the Merlin Patient Care System,” said Michael
J. Coyle, president of St. Jude Medical’s
Cardiac Rhythm Management Division. “With the
new ICD interface, we are demonstrating our commitment to making
follow-ups more efficient for both our bradycardia and tachycardia
customers, while focusing on patients.”
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 approximately 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, regulatory approvals, anticipated future product
launches, 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 March 16, 2006 (see Item 1A on pages
15-21) and in the Company’s Quarterly Report
on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page
32). The Company does not intend to update these statements and
undertakes no duty to any person to provide any such update under any
circumstance.