Principal Products
Cardiac Rhythm Management: The Company’s pacemaker systems treat patients with
hearts that beat too slowly, a condition known as bradycardia. Typically implanted
pectorally, just below the collarbone, pacemakers monitor the heart’s rate and,
when necessary, deliver low-level electrical impulses that stimulate an appropriate
heartbeat. The pacemaker is connected to the heart by one to three leads that
carry the electrical impulses to the heart and information from the heart back
to the pacemaker. An external programmer enables the physician to retrieve diagnostic
information from the pacemaker and reprogram the pacemaker in accordance with
the patient’s changing needs. Single-chamber pacemakers sense and stimulate only
one chamber of the heart (atrium or ventricle), while dual-chamber devices can
sense and pace in both the upper atrium and lower ventricle chambers. Bi-ventricle
pacemakers can sense and pace in three chambers: (atrium and both ventricle chambers).
St. Jude Medical’s current pacing products include the new Team ADx® pacemakers,
a group comprised of the Identity® ADx, Integrity® ADx, and Verity™ ADx families
of devices. The Identity® DR and Identity® XL DR devices were approved by the
FDA in March 2003, with the rest of the Team ADx™ devices receiving FDA approval
in May 2003. The Team ADx devices received European CE Mark in August 2003.
The Identity® ADx family models maintain the therapeutic advancements of previous
St. Jude Medical pacemakers, including the AF Suppression™ algorithm and the
Beat-by-Beat™ AutoCapture™ Pacing System. This family offers new Atrial Tachycardia(AT)/Atrial
Fibrillation(AF) arrhythmia diagnostics. The Integrity® ADx devices now offer
programmable electrograms. These features are designed to help physicians better
manage pacemaker patients suffering from AF—the world’s most common cardiac
arrhythmia.
St. Jude Medical also offers Identity® pacemakers with enhanced electrograms;
and Integrity® and Integrity® µ (Micro) pacemaker models, built on the Affinity®
platform with its Beat-by-Beat™ AutoCapture™ Pacing System. Other pacing products
include the Affinity® pacemakers, and the Entity® family of pacemakers, containing
the Omnisense® activity-based sensor. These pacemaker families contain many
advanced features and diagnostic capabilities to optimize cardiac therapy. All
are small and physiologic in shape to enhance patient comfort. The Microny®
II SR+ and Microny® K, are the world’s smallest pacemakers. The Microny® SR+
and the Regency® pacemaker families are available outside the United States.
The Identity® ADx, Integrity® ADx, Verity™ ADx, Identity®, Integrity®, Affinity®,
Entity® and Microny® and Regency® families of pacemakers all offer the unique
Beat-by-Beat™ AutoCapture™ Pacing System. The AutoCapture™ Pacing System enables
the pacemaker to monitor every paced beat to verify that the heart has been
stimulated (known as capture), delivers a back-up pulse in the event of noncapture,
continuously measures threshold, and makes adjustments in energy output to match
changing patient needs. In addition, the Identity® ADx, Integrity® ADx, Identity®
and Integrity® pacemakers include St. Jude Medical’s AF Suppression™ Algorithm,
a therapy designed to suppress atrial fibrillation.
St. Jude Medical also markets low-voltage device-based ventricular resynchronization
systems (bi-ventricular) designed for the treatment of heart failure and suppression
of atrial fibrillation. Within the United States, the Company’s pacemakers are
the only bi-ventricular pacing devices indicated for use in patients with chronic
atrial fibrillation who have been treated with AV nodal ablation. These device
systems include the Frontier™ and Frontier II™ (FDA approved in August 2004
and CE Mark approved in September 2004) bi-ventricular stimulation devices,
designed to enhance cardiac function by synchronizing the contractions of the
heart’s two ventricles, the Aescula® and QuickSite™ LV pacing leads, and the
Alliance™, Seal-Away™ CS and Apeel™ Catheter Delivery Systems.
St. Jude Medical’s current pacing leads include the Tendril® SDX (models 1688
and 1488), and Tendril® DX active-fixation lead families, and the IsoFlex® S
and Passive Plus®DX passive-fixation lead families, all available worldwide.
All these lead families feature steroid elution, which helps suppress the body’s
inflammatory response to a foreign object. The passive fixation Membrane® EX
lead family is also currently available outside the United States.
The Company’s ICD systems treat patients with hearts that beat inappropriately
fast, a condition known as tachycardia. ICDs monitor the heartbeat and deliver
higher energy electrical impulses, or “shocks,” to terminate ventricular tachycardia
(VT) and ventricular fibrillation (VF). In VT, the lower chambers of the heart
contract at an abnormally rapid rate and typically deliver less blood to the
body’s tissues and organs. VT can progress to VF, in which the heart beats so
rapidly and erratically that it can no longer pump blood. Like pacemakers, ICDs
are typically implanted pectorally, connected to the heart by leads, and programmed
non-invasively.
The Company’s full ICD product offering includes the Epic™+ VR/DR and Epic™
VR/DR ICDs, the Atlas®+ VR/DR and Atlas® VR/DR ICDs, Photon® µ (Micro) DR/VR
ICD, Photon® DR ICD, and Contour® MD ICD. St. Jude Medical received FDA approval
and European CE Mark of the Epic™+ VR/DR ICDs in April 2003, and FDA approval
and European CE Mark of the Atlas®+ VR/DR ICDs in October 2003. The Epic™ ICD
family devices are very small ICDs that deliver 30 joules of energy. The Atlas®
ICD family devices offer high energy and small size without compromising charge
times, longevity or feature set flexibility. The Epic™+ DR ICD and the Atlas®+
DR ICD both contain St. Jude Medical’s AF Suppression™ algorithm, which is clinically
proven to reduce AF burden.
The Company’s ICDs are used with the single and dual-shock electrode Riata®
transvenous defibrillation leads. The Riatai® integrated bipolar single and
dual-shock leads were FDA approved and launched in April 2004 and received European
CE mark in May 2004, making the Riata® ICD leads the most complete ICD lead
family currently available. The Riata® leads are an advanced family of small-diameter,
steroid-eluting, active or passive fixation defibrillation leads.
In June 2004, St. Jude Medical received FDA approval for its line of products
designed to treat heart failure. These products included the Atlas+ HF, the
highest output cardiac resynchronization therapy device (CRT-D) in the industry
at 36 joules delivered and 42 joules stored; the Epic HF, the smallest 30 joule
CRT-D available; the Aescula Model 1055K left-ventricular lead; and the QuickSite
Model 1056K, the most stable left-ventricular lead in the world with a less
than 1% dislodgment rate.
In November 2004, St. Jude Medical received FDA approval for its Atlas+ HF
and Epic HF ICDs with the ventricle to ventricle (V-V) timing feature. V-V timing
allows the clinician to program the timing between the two ventricles to optimize
ventricular function and cardiac output, which may further increase the number
of responders to CRT. Full launch activities began in December 2004.
In December 2004, St. Jude Medical launched the QuickSite Bipolar Model 1056T
left-ventricular lead in Europe. That same month, a pre-market approval (PMA)
application to the FDA was made for the 1056T. St. Jude Medical expects FDA
approval and full market launch for the 1056T by mid-year 2005.
The Company’s pacemakers and ICDs interact with an external device referred
to as a programmer. A programmer has two general functions. First, a programmer
is used at the time of pacemaker and ICD implants to establish the initial therapeutic
settings of these devices as determined by the physician. A programmer is also
used for follow-up patient visits, which usually occur every three to 12 months,
to download stored diagnostic information from the implanted devices and to
verify appropriate therapeutic settings.
Programmers are small and mobile and are maintained predominantly by the Company’s
sales representatives at their homes and transported to the hospitals in their
vehicles when either implants or follow-up visits are scheduled. In these cases,
the Company’s sales representatives are on site at the hospitals to assist the
physicians, nurses and technicians in operating the programmers at the time
of patient implants or follow-up visits. Alternatively, programmers are stored
at high-volume cardiac centers as a matter of convenience.
Since the introduction of programmable pacemakers in about 1977, all pacemaker
manufacturers, including the Company, have retained title to their programmers
which are used by their field sales force or by physicians and nurses or technicians.
Although the Company derives no direct revenue from the use of its programmers,
new pacemakers and ICDs generally require the use of the Company’s programmer
at the time of implant and follow-up.
St. Jude’s Model 3510 universal series pacemaker and ICD programmer is an easy-to-use
programmer that supports the Company’s pacemakers and ICDs. The Model 3510 universal
series programmer allows the physician to utilize the diagnostic and therapeutic
capabilities of the Company’s pacemakers and ICDs.
Housecall Plus, approved for use in the United States and Canada, is a remote
monitoring system for St. Jude Medical ICDs (Atlas, Atlas+, Atlas+ HF, Epic,
Epic+, Epic HF) that works with standard analog telephone lines. It consists
of a dedicated receiver (mini desktop computer) and a small answering machine
sized transmitter. Physicians can better manage their increased number of ICD
patients by conducting remote follow-up sessions efficiently, obtaining complete
diagnostics in real time (similar to an in-office data interrogation), and choosing
how they wish to use/operate the system. Patients enjoy the comfort and convenience
of their own home while interacting with a live technician to assist them in
transmission.
Electrophysiology is the study of the heart’s electrical activity, which controls
how quickly and effectively the heart beats. EP catheters and introducers are
placed into the human heart through blood vessels in order to diagnose and treat
cardiac arrhythmias (abnormal heart rhythms).
St. Jude Medical offers a variety of EP products in multiple configurations.
For diagnosing arrhythmias, the Company’s Supreme™ and Response™ fixed-curve
catheters and Livewire™ steerable diagnostic catheters provide options for physicians
dealing with unique anatomical situations. Swartz™ Guiding Introducers and the
Telesheath™ Left Atrial Introducer System provide a stable foundation in the
left atrium, guiding catheters to precise locations. Finally, the Company’s
Livewire TC™ Ablation Catheters apply therapeutic radiofrequency (RF) energy
to cardiac tissue, helping to manage or cure many cardiac arrhythmias.
Cardiac Surgery: Heart valve replacement or repair may be necessary because
the natural heart valve has deteriorated due to congenital defects or disease.
Heart valves facilitate the one-way flow of blood in the heart and prevent significant
backflow of blood into the heart and between the heart’s chambers. St. Jude
offers both mechanical and tissue replacement heart valves and valve repair
products. The St. Jude Medical® mechanical heart valve has been implanted in
over 1.5 million patients worldwide. The SJM Regent® mechanical heart valve
was approved for sale in Europe in December 1999 and received FDA approval for
U.S. market release in March 2002. In the United States, the Company markets
the Toronto SPV® stentless tissue valve, which received FDA approval in 1997.
Outside the United States, the Company markets the SJM Epic™ stented tissue
heart valve, the SJM Biocor® stented tissue valve, the Toronto SPV® stentless
tissue valve and the Toronto Root™ tissue valve. The Toronto Root® tissue valve
is a stentless aortic root bioprosthesis used when aortic root disease accompanies
valve disease. The Toronto Root® tissue valve is currently in U.S. and Canadian
clinical studies. The SJM Epic® stented tissue heart valves are also currently
in U.S. clinical studies. St. Jude anticipates FDA approval of the SJM Biocor®
tissue valve in the second half of 2005.
The Company also offers a line of heart valve repair products, including the
semi-rigid SJM® Séguin annuloplasty ring and the fully flexible SJM Tailor™
annuloplasty ring. Annuloplasty rings are prosthetic devices used to repair
diseased or damaged mitral heart valves.
During the fourth quarter of 2004, the Company initiated a limited market release
of its Epicor™ Cardiac Ablation System (Epicor System). This technology was
acquired as part of the Company’s Epicor acquisition in June 2004. By applying
HIFU to the outside of a beating heart, the Epicor System creates cardiac ablation
lesions without the need to put the patient on a heart-lung bypass machine,
leading to safe, effective, and reproducible therapy. The primary components
of the Company’s Epicor System include the Ablation Control System™ (ACS) that
generates and controls the ultrasound energy, the UltraCinch™ that wraps around
the heart and creates a long linear lesion and the UltraWand™ that allows for
additional linear lesions to be customized by the physician.
Cardiology and Vascular Access: The Company produces specialized disposable
cardiovascular devices, including vascular closure devices, angiography catheters,
bipolar temporary pacing catheters, percutaneous catheter introducers and diagnostic
guidewires.
The Company’s vascular closure devices are used to close femoral artery puncture
sites following angioplasty, stenting and diagnostic procedures. St. Jude Medical’s
newest vascular closure product, the Angio-Seal™ STS Plus, was launched globally
in the third quarter of 2003. The Angio-Seal™ STS Plus model has incorporated
improvements to the STS Platform device design to provide customers a device
which provides optimal product performance, reliability and ease of use. The
design changes include a newly designed arteriotomy locator that provides a
smooth transition from locator to insertion sheath, newly positioned blood inlet
holes that eliminate the insertion sheath tip from having to exit and re-enter
the arteriotomy site and a new lock-in hub design. The design still incorporates
many of the design features of the STS Platform, including the self-tightening
suture, which eliminates the need for a post-placement spring, allowing for
completion of the entire procedure in the catheterization lab. It also integrates
the Secure-Cap™, which facilitates proper deployment through audible, tactile
and visual confirmations during the closure process.
Angiography catheters, such as St. Jude’s Spyglass™ angiography catheters,
are used in coronary angiography procedures to obtain images of coronary arteries
to identify structural cardiac diseases. St. Jude’s bipolar temporary pacing
catheters are inserted percutaneously for temporary use (ranging from less than
one hour to a maximum of one week) with external pacemakers to provide patient
stabilization prior to implantation of a permanent pacemaker, following a heart
attack, or during surgical procedures. The Company produces and markets several
designs of bipolar temporary pacing catheters, including its Pacel™ biopolar
pacing catheters, which are available in both torque control and flow-directed
models with a broad range of curve choices and electrode spacing options.
Percutaneous catheter introducers are used to create passageways for cardiovascular
catheters from outside the human body through the skin into a vein, artery or
other location inside the body. St. Jude’s percutaneous catheter introducer
products consist primarily of peel-away and non peel-away sheaths, sheaths with
and without hemostasis valves, dilators, guidewires, repositioning sleeves and
needles. These products are offered in a variety of sizes and packaging configurations.
Diagnostic guidewires, such as St. Jude’s GuideRight™ and HydroSteer™ guidewires,
are used in conjunction with percutaneous catheter introducers to aid in the
introduction of intravascular catheters. St. Jude’s diagnostic guidewires are
available in multiple lengths and incorporate a surface finish for lasting lubricity.
Atrial Fibrillation: Electrophysiology (EP) is the study of the heart’s electrical
activity, which helps control how quickly and effectively the heart beats. EP
catheters and introducers are placed into the human heart through blood vessels
in order to diagnose and treat cardiac arrhythmias (abnormal heart rhythms).
We offer a variety of EP products in multiple configurations. For diagnosing
arrhythmias, our Supreme™ and Response™ fixed-curve catheters and Livewire™
steerable diagnostic catheters provide options for physicians dealing with unique
anatomical situations. Swartz™ Guiding Introducers and the Telesheath™ Left
Atrial Introducer System provide a stable foundation in the left atrium, guiding
catheters to precise locations. We also released in mid-2005 the Agilis™ Steerable
introducer, a tool that provides additional stability and facilitates the delivery
of ablation catheters in challenging anatomical situations. Finally, our Livewire
TC™ Ablation catheters apply therapeutic radiofrequency energy to cardiac tissue,
helping to manage or cure many cardiac arrhythmias.
During the fourth quarter of 2004, we initiated a limited market release of
our Epicor™ Cardiac Ablation System (Epicor™ System). This technology was acquired
as part of our Epicor acquisition in June 2004. By applying high intensity focused
ultrasound (HIFU) to the outside of a beating heart, the Epicor™ System creates
cardiac ablation lesions without the need to put the patient on a heart-lung
bypass machine. The primary components of our Epicor™ System include the Ablation
Control System™ that generates and controls the ultrasound energy, the UltraCinch™
that wraps around the heart and creates a long linear lesion and the UltraWand™
that allows for additional linear lesions to be customized by the physician.
In January 2005, we completed our acquisition of ESI, a manufacturer of advanced
mapping systems for arrhythmias. The EnSite® System is used by electrophysiologists
to create three-dimensional models of cardiac chambers and collect and display
timing and voltage information on the chamber model to facilitate accurate diagnosis
and direct the delivery of ablation therapy. Along with the EnSite® System hardware,
a procedure performed with the EnSite® System requires the use of either the
EnSite® Array noncontact mapping catheter or EnSite® NavX patch kits.