St. Jude Medical Announces FDA Approval of New ICD Software for the Merlin(TM) Patient Care System
November 07 2006 - 9:00AM
Business Wire
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.
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and
Drug Administration (FDA) approval of its new tachycardia software
for the Merlin(TM) 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.
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