St. Jude Medical Announces European Approval of Accent MRI Pacemaker System
April 18 2011 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that it has received European CE Mark
approval for its Accent MRI™ pacemaker and Tendril MRI™ lead. The
system, designed and tested for safe use in a Magnetic Resonance
Imaging (MRI) environment and approved as MR-Conditional, allows
patients to undergo full-body, high-resolution MRI scans.
“The Accent MRI pacemaker system meets important clinical needs
without compromise by offering superior pacing technology in
addition to full MRI-compatible scanning capabilities with no
anatomical zone or MRI power restrictions,” said Eric S. Fain,
M.D., president of the St. Jude Medical Cardiac Rhythm Management
Division.
Each year, approximately one million pacemakers are implanted
worldwide, and up to 75 percent of pacemaker patients could benefit
from MRI scans during the lifetime of their devices. The new Accent
MRI pacemaker system is an advanced pacing platform that provides
wireless telemetry and algorithms to address individual patient
conditions, with the added benefit of MRI scanning capability.
“Many of my patients have faced severe health problems, such as
cancer, stroke and neurological disorders, for which MRI is fast
becoming the preferred diagnostic tool,” said Burkert Pieske, M.D.,
chief of cardiology at University Hospital Graz in Graz, Austria.
“Until recently, many of my pacemaker patients were contraindicated
for an MRI, but the new Accent MRI system allows my patients a
full-featured pacemaker with access to full-body scanning to
address their additional health concerns.”
The system features an MRI Activator™ device that provides a
simple alternative option for programming the device to the
appropriate MRI mode for use during the scan. Since it does not
require a programmer, this increases both clinical and personnel
efficiency. A single button press on the handheld MRI Activator
device can be used to program the specific device parameters to be
used during the MRI scan. These parameters are pre-selected by the
patient’s physician and stored in the Accent MRI pacemaker. The MRI
Activator can then be used to program the device back to its
original settings after the scan has been completed.
“The Accent MRI pacemaker system offers MRI capabilities without
any trade-offs,” said Karlheinz Tscheliessnigg, M.D., chief of
cardiac surgery at University Hospital Graz in Graz, Austria. “The
device is not only an advanced pacemaker that allows for efficient
patient management, but it also features the Tendril MRI lead that
gives me the flexibility to easily maneuver the lead into position
because of its excellent handling characteristics.”
The Tendril MRI pacing lead, built on the proven Tendril lead
platform, offers unique design advantages for safe, MR-Conditional
scanning. The thin diameter makes it easier for physicians to
implant, as it retains the handling characteristics of the well
established Tendril platform of pacing leads. In addition, the lead
features Optim™ lead insulation, the first silicone-polyurethane
co-polymer material created specifically for cardiac lead use. The
Optim insulation is designed for long-term reliability, while
providing physicians with better flexibility and handling to
facilitate device implantation.
In addition, the Accent MRI pacemaker system features
InvisiLink™ telemetry that enables secure, wireless communication
between the implanted device and the programmer used by the
clinician. Wireless communication is used when clinicians implant
the device and during follow-up appointments, which can be
performed in the office or through remote monitoring via the
Merlin.net® Patient Care Network (PCN), a secure, Internet-based
remote care system. The Merlin.net PCN gathers and stores data from
the implant procedure, in-clinic follow-up visits and remote
transmissions sent from a patients home, allowing for more
efficient and convenient care and device management, including the
ability to perform a full interrogation of the pacemaker at home
after the patient completes their MRI study.
The Accent MRI pacemaker has several features that simplify
patient management. These features include AutoCapture® Pacing
System technology that measures the heart’s reaction to pacing
beat-by-beat, and the VIP® algorithm that enables the heart’s
intrinsic rhythm to prevail when appropriate, thereby reducing
unnecessary ventricular pacing.
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 develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn. and has four major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit 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 Risk Factors and Cautionary Statements sections of the
Company's Annual Report on Form 10-K for the fiscal year ended
January 1, 2011. The Company does not intend to update these
statements and undertakes no duty to any person to provide any such
update under any circumstance.
SJM (NYSE:STJ)
Historical Stock Chart
From Jun 2024 to Jul 2024
SJM (NYSE:STJ)
Historical Stock Chart
From Jul 2023 to Jul 2024