- MOMENTUM 3 Study meets primary endpoint
for short-term indication
- Results presented during late-breaking
clinical trial session at the AHA Scientific Sessions
- MOMENTUM 3 Study data published in the
New England Journal of Medicine
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced results of the MOMENTUM 3 U.S. IDE
Clinical Study during a late-breaking clinical trial session at the
American Heart Association (AHA) Scientific Sessions in New
Orleans. The MOMENTUM 3 study compared the HeartMate 3™ Left
Ventricular Assist System (LVAS) to the HeartMate II™ LVAS in
treating advanced stage heart failure and is the largest LVAD trial
in the world to evaluate both short-term and long-term patients in
a single study. The study results demonstrated patients receiving
the HeartMate 3 LVAS had an 86.2 percent survival rate with freedom
from disabling stroke and reoperation to repair or replace the
device.
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HeartMate 3 Left-ventricular Assist
System (Photo: Business Wire)
The MOMENTUM 3 IDE study is a prospective, multi-center,
randomized, unblinded, study evaluating the safety and
effectiveness of the HeartMate 3 LVAS when used for the treatment
of advanced, refractory, left ventricular heart failure. More than
1,000 patients with New York Heart Association (NYHA) Class IIIB or
IV heart failure are participating in the study. Patients are being
followed for a short-term endpoint of six months, and a long-term
endpoint of two years. Current data show the results at the
six-month follow-up in the first 294 patients enrolled.
The primary endpoint for the study was six months survival with
freedom from disabling stroke and reoperation to repair or replace
the device. The study met its primary endpoint (non-inferiority
P<0.0001; superiority P=0.037). There were no pump thrombosis
events reported in patients who were implanted with HeartMate 3
LVAS at six months, confirming the results observed with the
HeartMate 3 LVAS in the CE Mark trial. Rates of all other adverse
events were similar between the HeartMate 3 LVAS and historical
rates seen in the HeartMate II LVAS, which is the most widely used
and extensively studied LVAD commercially available. This study
included all-comers, which means researchers evaluated the device
regardless of whether the patient needed a short-term support
option while awaiting transplantation or a long-term support option
for those who are not candidates for cardiac transplantation.
“The Heartmate 3 LVAS improved clinical outcomes in the MOMENTUM
3 study by avoiding the need for surgical reoperation to replace or
remove the pump due to pump thrombosis,” said Dr. Mandeep R. Mehra,
medical director of Brigham and Women’s Hospital Heart and Vascular
Center in Boston. “More importantly, these clinical gains occurred
without an increase in other adverse events, providing important
therapeutic progress for our advanced heart failure patients.”
The HeartMate 3 LVAS is a small, implantable mechanical
circulatory support (MCS) device for advanced heart failure
patients who are awaiting transplantation or are not candidates for
heart transplantation. It is the first commercially approved (CE
marked) LVAD with Full MagLev™ technology, designed to minimize
complications and restore blood flow. The HeartMate 3 system
utilizes Full MagLev technology, which allows the device’s rotor to
be “suspended” by magnetic forces. This design aims to reduce
trauma to blood passing through the pump and improve outcomes for
patients.
“These data in the MOMENTUM 3 study represent the continued
advancement in therapy options available for patients living with
debilitating heart failure,” said Dr. John B. O’Connell, vice
president and medical director for mechanical circulatory support
at St. Jude Medical. “The HeartMate II LVAS is an extremely
important medical advancement with more than 24,000 implants having
occurred to date, and it is the only LVAD approved for both
Bridge-to-Transplant and Destination Therapy options in the U.S.
The data, now being seen with the HeartMate 3 LVAS, show that we
are taking the next steps in advancing medical therapy
options.”
Study Oversight Committee includes:
- Dr. Mandeep R. Mehra (Chair,
Publication and Presentation Committee), Brigham and Women’s
Hospital, Boston, MA
- Dr. Joseph Cleveland, University of
Colorado, Denver, CO
- Dr. Daniel Goldstein, Montefiore
Medical Center, NY, NY
- Dr. Nir Uriel, University of Chicago,
Chicago, IL
The HeartMate 3 LVAS is CE Mark approved and limited by federal
law to investigational use in the United States.
About Heart Failure
Heart failure is a widespread, chronic condition that develops
when the heart muscle weakens and is unable to pump a sufficient
amount of blood throughout the body. Heart failure worsens over
time and is typically caused by persistent high blood pressure,
heart attack, valve disease and other forms of heart disease or
birth defects. Left untreated, the lack of adequate blood flow
causes the organs to progressively fail, resulting in numerous
medical complications that deteriorate a person’s quality of
life.
According to the American Heart Association (AHA) and the Heart
Failure Society of American (HFSA), about 6 million Americans are
living with heart failure today, and 670,000 new cases are
diagnosed each year. In the United States, the number of deaths
from this condition has more than doubled since 1979.1
About the HeartMate 3 Left Ventricular Assist System
The HeartMate 3 LVAS includes a centrifugal blood pump that is
implanted directly onto a patient's native heart and designed to
supplement the pumping ability of the weakened heart's left
ventricle, which is responsible for pumping oxygen-rich blood from
the lungs throughout the body. The device is implanted above the
diaphragm, immediately next to the native heart, and is attached to
the aorta (the main artery that feeds blood into the entire body),
leaving natural circulation in place while providing all of the
energy necessary to propel blood throughout the body. The patient
wears an external, wearable controller and battery system that
powers the pump. The HeartMate 3 LVAS can pump up to 10 liters of
blood per minute.
About St. Jude Medical’s Heart Failure Business
St. Jude Medical is pioneering heart
failure disease management with innovative solutions like the
CardioMEMS™ HF System, ground-breaking quadripolar technology
and, in select European markets, the HeartMate 3™ left
ventricular assist system and our first-to-market
MultiPoint™ Pacing technology.
St. Jude Medical collaborates with heart failure
specialists, clinicians and advocacy partners to provide a
comprehensive product portfolio that includes innovative,
cost-effective solutions that help reduce hospitalizations and
improve patient quality of life for heart failure patients around
the world.
For more information about St. Jude Medical’s focus on heart
failure, visit the St. Jude Medical Heart Failure Media
Kit or the St. Jude Medical PULSE Blog.
Information for patients to learn more about heart failure can
be found at www.heartfailureanswers.com.
About St. Jude Medical
St. Jude Medical is a leading global medical device
manufacturer and is dedicated to transforming the treatment of some
of the world's most expensive epidemic diseases. The company does
this by developing cost-effective medical technologies that save
and improve lives of patients around the world.
Headquartered in St. Paul, Minn., St. Jude
Medical employs approximately 18,000 people worldwide and has
five major areas of focus that include heart failure, atrial
fibrillation, neuromodulation, traditional cardiac rhythm
management and cardiovascular. For more information, please
visit sjm.com or follow us on
Twitter @SJM_Media.
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, reimbursement
strategies, 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 2, 2016 and Quarterly Report on Form
10-Q for the fiscal quarter ended October 1, 2016. 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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version on businesswire.com: http://www.businesswire.com/news/home/20161116006280/en/
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorKristi Warner, 651-756-2085Media
Relationskwarner@sjm.com
SJM (NYSE:STJ)
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