St. Jude Medical to Present Innovative Technologies and Important Clinical Updates at Heart Rhythm 2005
May 04 2005 - 12:09PM
Business Wire
St. Jude Medical Inc. (NYSE:STJ) will showcase its most advanced
cardiac care products and present the latest data from clinical
studies at Heart Rhythm 2005, the 26th Annual Scientific Sessions
of the Heart Rhythm Society (HRS), to be held May 4th - 7th in New
Orleans, Louisiana. "Heart Rhythm 2005 brings together the world's
leading electrophysiologists and cardiologists to discuss
breakthrough cardiac technologies and review the latest clinical
research in a lively forum," said Daniel J. Starks, Chairman,
President and Chief Executive Officer of St. Jude Medical. "We look
forward to presenting our newest innovations, which extend the
benefits of our technologies, procedures and clinical studies to
many thousands of cardiac patients." Advancements in the Diagnosis
and Treatment of AF Atrial fibrillation (AF), the rapid,
unsynchronized quivering of the heart's upper chambers - a
debilitating condition that affects over six million people
worldwide - will be a special focus of Heart Rhythm 2005. St. Jude
Medical will profile its most advanced cardiac diagnostic, mapping
and visualization technologies for patients suffering from AF or
other cardiac rhythm disorders. Among the catheter-based and
surgically-based electrophysiology products and technologies to be
featured by St. Jude Medical at Heart Rhythm 2005 are the
following: -- The Agilis(TM) steerable introducer, which offers
outstanding agility and stability to help create precise cardiac
ablation lesions. It also offers a steering mechanism to allow
small micro-movements with an ablation catheter, along with
atraumatic and radiopaque tip markers designed to facilitate safe
movement within the atria. -- The EnSite(R) system, which aids
navigation of diagnostic and therapeutic catheters used in ablation
and other electrophysiology catheterization procedures. -- The
Epicor(TM) cardiac ablation system, designed to create cardiac
ablation lesions through an off-pump, epicardial approach using
High Intensity Focused Ultrasound (HIFU) energy for focused,
precise lesions with a less-invasive surgical approach. -- The
Inquiry(TM) Optima(TM) diagnostic catheter, which is designed for
fast, stable positioning with true 180-degree deflection. It also
offers cost-savings by reducing the variety of catheters clinicians
need to stock, since the multi-deflectable shaft and variable loop
radius diameter make it adaptable to different patient anatomies.
-- The Cool Path(TM) steerable irrigated ablation catheter
(released in certain markets outside the U.S.), which uses a six
port irrigated tip design to help keep catheter tip temperature in
the desired range during radiofrequency ablation. Other St. Jude
Medical Cardiac Rhythm Management technologies on display at this
year's meeting are designed to help manage arrhythmias associated
with atrial fibrillation and heart failure, common comorbidities of
traditional bradycardia arrhythmias and ventricular tachycardia
arrhythmias. These include: -- The QuickSite(R) 1056T bipolar
left-heart pacing lead, approved for implantation with St. Jude
Medical cardiac resynchronization therapy (CRT) pacing systems; --
The U.S. activation of V-V (ventricle to ventricle) timing in the
Epic(TM) HF and Atlas(R)+ HF families of CRT-Ds, which helps
physicians optimize individual patient care by adjusting the delay
between ventricular outputs and choosing which chamber is paced
first; and -- The Frontier(TM) II system, now approved for cardiac
resynchronization therapy to reduce the symptoms of moderate to
severe heart failure (NYHA Class III or IV and EF less than or
equal to 35% and prolonged QRS), and the only device family
approved by the U.S. Food and Drug Administration (FDA) for
treating patients (NYHA Class II or III) who have undergone an AV
nodal ablation for chronic atrial fibrillation. These technologies
will complement our offering of new products for the traditional
bradycardia and tachyarrhythmia management market segments,
including: -- The IsoFlex(R) P bipolar pacing lead, which provides
a small diameter, polyurethane insulated lead in both ventricular
straight and atrial "J" shapes, designed to promote ease of
implant, higher pacing impedances and improved device longevity; --
The Riata(R) i high-voltage lead family, the world's thinnest
integrated bipolar implantable cardioverter defibrillator (ICD)
lead product, designed to offer physicians even greater flexibility
for managing patients with high defibrillation thresholds; -- The
Housecall Plus(TM) remote patient monitoring system, allowing
physicians to remotely interrogate ICD devices as part of patient
follow-up care; and -- The PSA (pacing system analyzer) Wand, which
integrates testing, programming and interrogation of implantable
cardiac devices into one easy-to-use system without the need for
separate analyzer hardware. New Cardiac Surgery Technologies Also
on Display St. Jude Medical will also showcase its broad portfolio
of mechanical and tissue heart valves, repair products, and other
cardiac surgery technologies, including: -- The new SJM(R) Masters
HP(TM) Valved Graft with Gelweave Valsalva(TM) technology, which
offers surgeons a premium quality composite valve graft combining
the exceptional hemodynamics of the St. Jude Medical Masters HP(TM)
valve with the implantability advantages of Vascutek's Gelweave
Valsalva(TM) Graft (designed to mimic the anatomy of natural
sinuses). -- The SJM(TM) Rigid Saddle Ring, to be market launched
later this year, which is the first annuloplasty ring available
with a complete natural saddle shape, intended to mimic the anatomy
of a healthy human mitral annulus. The ring is designed to reduce
stress on the chords and leaflets for a more durable repair, while
its unique sewing cuff allows for easier suturing. Important
Clinical Findings Made Possible by St. Jude Medical Sponsored
Research Physicians attending Heart Rhythm 2005 will also be able
to hear updated findings from two St. Jude Medical sponsored
clinical studies: -- V-V Timing Optimization phase of the RHYTHM
(Resynchronization HemodYnamic Treatment for Heart Failure
Management) ICD clinical study, which served as the basis for
adding V-V timing to St. Jude Medical CRT-Ds; and -- BREATHE (Base
Rest Rate Elevation for Apnea Therapy), a clinical study which
assesses the impact of an increased pacing rate in pacemaker
patients with sleep apnea. Any statements made regarding St. Jude
Medical's anticipated future product launches, regulatory
approvals, revenues, earnings, market shares, and potential
clinical success are forward-looking statements which are subject
to risks and uncertainties, such as those described in the
Financial Section of the Company's Annual Report to Shareholders
for the fiscal year ended December 31, 2004 (see pages 11-16).
Actual results may differ materially from anticipated results. St.
Jude Medical, Inc. (www.sjm.com) is dedicated to the design,
manufacture and distribution of innovative medical devices of the
highest quality, offering physicians, patients and payers
outstanding clinical performance and demonstrated economic value.
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