St. Jude Medical Begins U.S. Trial Studying ST Segment Monitoring Technology
August 31 2011 - 8:30AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that the first patient in a clinical study
examining the safety and effectiveness of an ST segment monitoring
feature in an implantable cardioverter defibrillator (ICD) has been
implanted with the investigational device in the United States. The
ST Monitoring to Detect ACS Events in ICD Patients (Analyze ST)
study will evaluate effectiveness of the feature in the Fortify® ST
ICD by analyzing its accuracy in detecting acute coronary events,
such as myocardial infarction, commonly known as a heart
attack.
Dr. Scott Allison and Dr. Paul B. Tabereaux of Heart Center,
Inc. at Huntsville Hospital in Alabama implanted the first two
patients in the trial. Commenting on the study, Dr. Allison said,
“When a patient is experiencing a heart attack, every minute
counts. For every 30 minutes that treatment is delayed, mortality
increases by 7.5 percent. Because symptoms can be vague, and
approximately one-third of patients don’t even have typical chest
symptoms, the average time it takes for a patient to seek treatment
has remained at almost 3 hours over the last decade. We hope the
device being studied in the Analyze ST trial can help provide
physicians with more information about coronary events that will
allow us to intervene and provide treatment earlier.”
The ST segment is a section of an electrocardiogram (ECG) that
depicts electrical changes between heartbeats. Changes in ST
segments have long been studied in clinical settings using external
devices as indicators for an obstruction of blood flow and oxygen
to the heart muscle (cardiac ischemia). However, due to several
limitations, it has not been practical to study them on a continual
basis. A method to monitor the ST segment without such limitations
could provide important insights into the overall clinical
assessment of patients at risk for coronary events. Monitoring for
ST changes within the heart of an ambulatory patient may provide
unique insight into the presence and severity of changes of the ST
segment and occurrence of ischemia in patients with coronary artery
disease (CAD).
The Analyze ST trial is a prospective, non-randomized,
multicenter, pivotal IDE investigation of up to 5,228 patients at
approximately 200 medical centers. St. Jude Medical received
investigational device exemption (IDE) approval from the U.S. Food
and Drug Administration (FDA) to study the safety and efficacy of
the ST segment monitoring feature in the Fortify ST ICD. The
sensitivity of the feature for detecting acute coronary syndrome
events will be the primary efficacy endpoint. The primary safety
endpoint will be assessed by reporting the percentage of patients
who experience a false positive detection.
“We know that ST segment changes can help us to identify CAD
events, so the continuous, internal monitoring that is possible
with this technology could provide physicians with an early warning
signal that a patient is experiencing an ischemic event,” said Dr.
Mark Carlson, chief medical officer and senior vice president of
research and clinical affairs for the St. Jude Medical Cardiac
Rhythm Management Division. “Since many patients do not experience
symptoms during a heart attack, this technology has the potential
to improve the diagnosis and treatment of cardiac ischemia.”
More than half of patients experiencing a heart attack die
before reaching a hospital. Even patients with stable CAD are at
high risk of having a life-threatening or potentially fatal
coronary event. Additionally, 15 to 20 percent of patients who have
had an ischemic event have recurrent events. As a result, CAD needs
to be managed on an ongoing basis to avoid a more unstable or life
threatening acute coronary event. Furthermore, approximately
two-thirds of ICD patients have cardiac ischemia, with many more
having risk factors for developing cardiovascular disease.
During ST segment shifts, the ICD records high-resolution
electrograms that can then be transmitted, along with additional
information, for download into the Merlin™ Patient Care System in
the clinic, or to the Merlin.net™ Patient Care Network from the
patient’s home via a Merlin@home™ transmitter. During the course of
the study, the device’s patient alert feature will also be turned
on, which would notify the patient via a vibratory alert when an ST
segment change occurs.
Based on the Fortify platform, the Fortify ST ICD features
advanced battery technology and circuitry that allow for a smaller
device, the highest energy output delivery (40J) of any ICD, as
well as rapid charge times, all while increasing device longevity.
The devices’ narrow shape, along with their small footprint, allows
physicians to implant them using a smaller incision, leading to
less time spent closing the incision and a reduced scar for the
patient.
The ST Monitoring Feature has received European CE Mark approval
and has been used in St. Jude Medical ICDs since December 2008. The
most recently CE Mark approved model is the Fortify ST ICD.
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 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 2, 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