Patient at Derriford Hospital in the United Kingdom is the first to undergo treatmentST. PAUL, Minn., Aug 18, 2008 (BUSINESS WIRE) -- St. Jude Medical, Inc. (NYSE:STJ) has received European CE Mark
approval and U.S. Food and Drug Administration (FDA) clearance for the
Epicor(TM) LP Cardiac Ablation System, a second generation technology
that uses HIFU (high intensity focused ultrasound) to surgically
ablate cardiac tissue to disrupt abnormal electrical impulses in the
heart.
The first patient to undergo treatment with the Epicor LP System
was a 73-year-old male with coronary artery disease and atrial
fibrillation (AF). The procedure was performed by Malcom
Dalrymple-Hay, FRCS Ph.D. FECTS, a cardiac surgeon at Derriford
Hospital in Plymouth, United Kingdom. The patient, who has suffered
from persistent AF for more than three years, had a normal heart
rhythm upon completion of the ablation procedure.
"An increasing volume of published literature is demonstrating the
benefits of treating pre-existing AF in patients who are undergoing
valvular or coronary artery bypass surgery," said Dr. Dalrymple-Hay.
"The Epicor LP System provides me with a technology that is flexible
enough to treat AF patients during either standard open chest
procedures or minimally invasive surgical procedures."
AF is the most common abnormal heart rhythm condition, affecting
millions of patients worldwide. With AF, the heart's upper chambers
(the atria) do not beat effectively due to abnormal electrical
activity. As a result, the heart cannot effectively pump blood, which
can lead to shortness of breath, heart palpitations and fatigue. If
left untreated, AF increases the risk of stroke five fold, according
to a study reported in the journal Stroke (Wolf et al, Atrial
Fibrillation as an Independent Risk Factor for Stroke: the Framingham
Study, 1991). AF is progressive and increases in frequency and
severity as patients grow older, and surgical cardiac ablation has
been found to provide relief from AF for a high percentage of
patients.
In surgical ablation performed with a HIFU energy source, energy
is focused from outside a beating heart. This treatment has been
designed to create precise and complete lines of cardiac tissue
ablation to block chaotic electrical impulses. The patient does not
need to be placed on a heart-lung bypass machine nor is the heart
stopped. Because HIFU energy is directed from outside the heart inward
(instead of from the inside out as is sometimes the case in ablations
performed with other energy sources), the risk of unintended
peripheral damage is minimized.
In contrast, the traditional surgical approach requires that
patients be placed on a heart-lung bypass machine with their hearts
stopped while a cardiac surgeon cuts maze-like patterns in the atrial
tissues and then sews the incisions to encourage the formation of
lesions, or tiny scars. Surgeons may also use alternative energy
sources, such as radiofrequency or cryothermy, to create lesions in
heart tissue. The lesions disrupt the abnormal electrical impulses
that cause AF.
The Epicor LP system has a lower profile (smaller relative to the
first generation technology) as well as other features designed to
facilitate easier device introduction and placement around and on
patients' hearts. In addition, the Epicor LP System is equally suited
for use in both closed-chest procedures performed through a single
incision, and in open-chest procedures.
In the December 2007 edition of The Annals of Thoracic Surgery,
the results of an independent investigator clinical trial led by Mark
Groh, M.D., showed that AF is effectively treated using the Epicor
Cardiac Ablation System when used concomitantly to corrective heart
surgery. The investigators reported that more than 83 percent of all
patients, followed for at least six months after surgery, were free
from AF. In addition, 86 percent of the patients followed for at least
18 months remained free from AF. The investigators reported that there
were no device or ablative procedure-related adverse events and
specifically noted an absence of esophageal, coronary or phrenic nerve
damage.
The 2007 results confirmed the findings of an earlier European
multi-center trial published in the September 2005 Journal of Thoracic
and Cardiovascular Surgery. The investigators in the European clinical
trial reported an 85 percent freedom-from-AF rate at six months
post-procedure - the study's primary efficacy end point - in patients
concomitantly treated for AF with the Epicor Cardiac Ablation System.
St. Jude Medical acquired Epicor Medical in 2004 and worked
closely with Dr. James Cox to develop the Epicor Medical HIFU ablation
system and its related surgical procedure. Dr. Cox is the developer of
the Cox-Maze surgical procedure for the treatment of AF and is
acknowledged by his peers as a pioneer in the field. Since the
acquisition, St. Jude Medical has been committed to improving the
manufacturability and performance of the HIFU surgical ablation
technology. St. Jude Medical continues to pursue expanded clinical
data, as well as additional tools to facilitate minimally invasive
procedures, for the technology.
The first generation Epicor System gained regulatory approval for
the treatment of AF in Europe in 2006. In the U.S., the first
generation Epicor System and the Epicor LP System received clearance
from the FDA for the surgical ablation of cardiac tissue but have not
been indicated by the FDA specifically for the treatment of AF.
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 12,500 people worldwide and has five major focus areas that
include: cardiac rhythm management, atrial fibrillation, cardiac
surgery, cardiology and neuromodulation. 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, 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 filed on February 27, 2008. The Company does not
intend to update these statements and undertakes no duty to any person
to provide any such update under any circumstance.
SOURCE: St. Jude Medical, Inc.
St. Jude Medical
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Angela Craig, 651-481-7789
or
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