St. Jude Medical, Inc. (NYSE:STJ) today announced it will
display and demonstrate products and technologies from the
company’s arrhythmia management portfolio at the 15th annual Boston
Atrial Fibrillation (BAF) Symposium. The featured products reflect
the company’s continued commitment to the treatment of abnormal
heart rhythms, including Atrial Fibrillation (AF).
St. Jude Medical will feature products and technologies that aid
physicians in the diagnosis and treatment of cardiac arrhythmias
and cardiovascular disease in the U.S. and around the globe.
Physicians can also get hands-on experience with several of the
company’s latest products by visiting the stations at the company’s
booths.
“St. Jude Medical is committed to developing curative solutions
which help treat atrial fibrillation and other debilitating cardiac
arrhythmias,” said Jane J. Song, president of the St. Jude Medical
Atrial Fibrillation Division. “We are designing innovative products
which help physicians to achieve safe, reproducible results and
improve patient outcomes for their ablation procedures as well as
sponsoring research that addresses important clinical questions
facing the medical community.”
St. Jude Medical is a leader in the worldwide cardiac ablation
and AF markets, which are estimated at about $2 billion annually.
In 2009, the company added several key products to its broad
portfolio:
EnSite™ Velocity
System: The next-generation of the industry-leading
EnSite™ System is designed to help physicians more efficiently
diagnose and guide therapy to treat abnormal heart rhythms. The
EnSite Velocity System creates a three-dimensional (3D) model of
the patient’s heart, allowing physicians to visualize their
patient’s unique anatomy with great detail. Physicians can then
quickly locate the source of the arrhythmia and formulate a
treatment strategy. The new platform is customizable, providing the
flexibility to better integrate current and future technology. The
EnSite Velocity has received FDA clearance and CE Mark
approval.
Catheters: St. Jude
Medical introduced two new catheters designed to quickly and
efficiently assess cardiac arrhythmias and a circular mapping
catheter with the industry’s smallest turning radius.
Reflexion™ High Density Mapping
Catheter: The first
high-density mapping catheter in the U.S. from St. Jude Medical
leverages the capabilities of the EnSite™ System to quickly create
highly detailed anatomical and electrical maps of the heart. These
maps help physicians in the diagnosis and treatment of complex
arrhythmias. The catheter’s efficiency in gathering information,
versatility and predictable electrode positioning may reduce the
number of products and the amount of time needed for a procedure.
It also has CE Mark approval.
Inquiry™
AFocus II Catheter: The new double-loop catheter marks St.
Jude Medical’s entry into the growing high-density mapping catheter
market in Europe. The high concentration of electrodes and the
double loop is designed to increase the catheter’s endocardial
tissue contact, and is intended to help physicians collect more
information in a given area and potentially aid in a more accurate
diagnosis of complex arrhythmias. The catheter, which also expands
the capabilities of the EnSite System, may help to reduce the
number of products and the amount of time needed for a given
procedure by providing an anatomical model of the heart with just
one catheter. The catheter has CE Mark approval.
Reflexion™ Spiral 5 F DuoDeca Variable
Radius Catheter: The next-generation circular atrial mapping
catheter is flexible and highly maneuverable, which helps
physicians to better access the areas of the heart necessary to
identify the heart’s electrical signals. At 51 mm, the DuoDeca has
smallest turning radius found in a catheter, which aids navigation
in smaller and tighter spaces in the atria. The catheter has FDA
clearance and CE Mark approval.
Agilis™ Specialty
Introducers: St. Jude Medical has also expanded its
portfolio of steerable access products, building on its leading
Agilis™ NxT family of products designed to help diagnose and treat
specific cardiac arrhythmias. Physicians can visit the Agilis
Introducer Station to navigate a sample left atrium using the
Agilis NxT family of products, including the new Agilis NxT Large
Curl Steerable Introducer in different sizes and the ACross™
Transseptal Access System.
Epicardial
Catheter System: The Epicardial Catheter System features the
Agilis™ EPI Steerable Introducer and Response™ Electrophysiology
Catheter. It is the only catheter system cleared for use in an
epicardial application, and was designed to help physicians gain
access to the outside surface of patients’ hearts. The Epicardial
Agilis™ EPI Steerable Introducer allows expanded access in
hard-to-reach areas of the epicardial space while providing needed
stability for a wide range of catheters and procedures. The
catheter system has FDA clearance.
Agilis™ NxT
Large Curl Steerable Introducer: The introducer was designed
to provide physicians with expanded access for further reach in the
left side of the cardiac anatomy, while providing stability for a
wide range of EP catheters for mapping and ablation. The
bi-directional, steerable sheath offers access to areas that may
have been previously out of reach for patients with large or
remodeled hearts. The introducer has FDA clearance and CE Mark
approval.
Cardiac Rhythm Management
Products: St. Jude Medical is committed to developing
smarter, more active products which reduce patient risk and improve
physician control during procedures. The company’s comprehensive
portfolio of wireless CRM technologies is changing the way that
physicians view connectivity and allows them to more efficiently
manage their patients.
Accent™ RF and Anthem™ RF Pacemakers: The market’s first completely
wireless pacemakers from implant through follow-up, the Accent RF
pacemaker and Anthem RF cardiac resynchronization therapy pacemaker
(CRT-P) enable physicians to wirelessly program the devices,
transmit comprehensive diagnostic data and be alerted to important
changes in the device or with the patient’s condition through the
Merlin.net™ PCN (Patient Care Network). The Accent RF and Anthem RF
pacemakers have received FDA and CE Mark approval.
Merlin.net® Patient Care Network: A
secure, Internet-based remote care system for patients with
implanted medical devices that gathers and stores data from the
implant procedure, in-clinic follow-up visits and from remote
transmissions sent from a patient’s home. The most recently
launched version of Merlin.net PCN, version 4.0, provides an
additional feature called DirectTrend™ Viewer, which graphically
displays patient trends and disease progression. This allows
physicians to more effectively and efficiently manage patients
through interactive views of patient data over time. Version 4.0 of
the Merlin.net PCN has received FDA and CE Mark approval.
Durata™
Defibrillation Lead with SJ4 Connector: The SJ4 connector
system features a single connection between the device and the
defibrillation lead, and a single set screw (used to tighten and
secure the lead to the device). Previous defibrillator lead designs
required at least three separate connections and as many as eight
set screws. The reduced number of lead connections may also lessen
the risk of lead-to-can abrasion, a known complication that can
occur in patients who have an implantable device. The Durata
Defibrillation Lead with SJ4 Connector has received FDA and CE Mark
approval.
Other products on display which aid physicians in managing
cardiac arrhythmias include:
Visualizing
& Recording: EnSite Array™ Catheter, EP-WorkMate™
Recording System, and ViewMate™ II Ultrasound System with ViewFlex™
Catheter
Access
& Diagnosis: ACross™ Transseptal Access System, Swartz™
Braided Transseptal Guiding Introducers, Ultimum™ Introducers,
FastCath™ Introducers, Livewire™ and Inquiry™ Steerable
Electrophysiology Catheters, TigerWire™ Guidewire, HydroSteer™
Guidewire, and Venture™ Guidewires
Ablation
Catheters: Safire™ Bi-directional Ablation Catheters and
Therapy™ Cool Path™ Irrigated Ablation System
Hemostasis
Management Devices: Angio-Seal™ Evolution, RadiStop™ and
FemoStop™ Gold
CRM
Products: Current™ Plus ICD, Promote™ Plus CRT-D, QuickFlex™
LV Lead, OptiSense™ Optim™ Pacing Lead, Tendril™ STS Lead, and SJM
Confirm™ Implantable Cardiac Monitor
Products for sale in the U.S. will be on display in booth 317
and products for sale in international markets will be in booth 311
at the World Trade Center Exhibit Hall on Thurs., Jan. 14 from
11a.m. - 5 p.m., Fri., Jan. 15 from 10 a.m. - 5 p.m. and Sat., Jan.
16 from 9:30 a.m. - 2 p.m. For additional information about the
products displayed in the St. Jude Medical booth, please visit
SJMprofessional.com.
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. Headquartered in St. Paul, Minn., St.
Jude Medical employs more than 14,000 people worldwide 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 Quarterly Reports on Form 10-Q for the fiscal quarters
ended April 4, 2009, July 4, 2009 and October 3, 2009. 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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