St. Jude Medical Expands Its Heart Failure Portfolio with SyncAV CRT Technology, Providing Physicians Another Option for Mana...
June 23 2016 - 8:00AM
Business Wire
Adding SyncAV™ CRT technology to the company’s comprehensive
heart failure offerings provides further advantages to the St. Jude
Medical portfolio to support physicians seeking new treatment
options for heart failure patients
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, announced CE Mark approval and launch of SyncAV™ CRT
software, designed to build upon the company’s first-to-market
MultiPoint™ Pacing technology and further optimize St. Jude
Medical’s comprehensive cardiac resynchronization therapy (CRT)
portfolio. MultiPoint Pacing technology with the SyncAV CRT
software algorithm is designed to address and effectively treat
heart failure patients who are not responsive to other pacing
options. The SyncAV technology, which automatically adjusts pacing
based on real-time changes in a patient’s cardiac condition, also
provides physicians the opportunity to further improve treatment of
patients who have responded positively to traditional CRT.
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Quadra Assura MP CRT-D. Courtesy of St.
Jude Medical.
In addition to the approval of SyncAV CRT software, the company
has also received CE Mark approval for the Quadra Assura MP™
CRT-Defibrillator (CRT-D) with full-body magnetic resonance (MR)
labeling. With the updated labeling, patients will have
unrestricted access to MRI diagnostic testing. Approvals of the
SyncAV CRT software and Quadra Assura MP CRT-D with full-body MRI
support the continued rollout of MultiPoint Pacing technology
throughout Europe.
“Although we have made substantial improvements in how we treat
heart failure patients, there are still certain patients who are
not getting the outcomes with traditional CRT that we would like to
see. The SyncAV CRT algorithm dynamically individualizes
programming to work towards providing patients with the right
settings at the right time helping offer the best possible outcome
for even our most complex patients,” said Dr. Timothy Betts,
consultant cardiologist and electrophysiologist at the Oxford Heart
Centre in the John Radcliffe Hospital. “Our goal is to utilize the
technology to improve outcomes while offering patients who do not
respond to therapy with additional options for treatment.”
For patients suffering from heart failure, CRT technology
resynchronizes the lower chambers (ventricles) of the heart by
sending uniquely programmed electrical impulses to stimulate each
ventricle to beat in sync to offer the best cardiac performance.
St. Jude Medical has introduced innovative solutions to enhance its
CRT product portfolio to improve the care of the
approximately 23 million people worldwide afflicted with
congestive heart failure. While studies have shown that CRT can
improve the quality of life for many patients with heart
failure, some patients do not respond optimally to traditional CRT,
leaving physicians with limited options to improve their clinical
outcomes for their patients. The latest heart failure offerings by
St. Jude Medical will provide physicians and patients additional
options that can help maximize the therapeutic effects of CRT.
Clinical Research at Scientific Sessions
The MultiPoint Pacing technology, featured on the Quadra Assura
MP™ CRT-D and the Quadra Allure MP™ CRT-P, including SyncAV CRT
technology, as well as the Quadra Assura MP CRT-D with full-body
MRI were all showcased at this year’s annual CARDIOSTIM-EHRA
EUROPACE 2016. In addition, the investigational device exemption
(IDE) clinical study results for the MultiPoint Pacing technology
were presented during a late-breaking clinical trial session at the
congress. The MPP IDE study met its primary endpoints of safety and
efficacy, and additional analyses indicated a positive impact of
MultiPoint Pacing programming on patient response to therapy.
An Italian registry on multipoint left-ventricular pacing in CRT
(IRON-MPP) was presented at the congress and also published in
Europace. Author and presenter of the data, Dr. Giovanni
Forleo, electrophysiologist at the University
Hospital of Tor Vergata, Rome, Italy, said, “Our
goal with this study was to help build a large body of clinical
evidence to inform clinical decision-making standards for the
management of heart failure patients implanted with MultiPoint
Pacing capable CRT-D devices. The results of this study show that
establishing optimal programming with the MultiPoint Pacing
technology can realize a maximized benefit for patients.”
CRT includes a lead (Quartet™ Quadripolar LV Lead) placed on the
lower left chamber of the heart (ventricle). The left ventricle
pumps oxygenated blood from the heart out to the rest of the body.
MultiPoint Pacing technology is designed to deliver independent
electrical pulses to multiple locations on the Quartet lead to make
the heart’s lower chambers pump in a more coordinated way to mirror
the natural contractions of a healthy heart. More than 65 abstracts
and publications demonstrate that this increases the number of
patients who benefit from this type of therapy (CRT), including one
presented at the American College of Cardiology (ACC) 2016 meeting
in Chicago, which demonstrated a 90 percent responder rate for
patients at one year follow-up using MPP programming.
St. Jude Medical also developed and launched the industry’s
first quadripolar pacing system in Europe in 2009 featuring four
pacing electrodes, offering physicians the ability to effectively
and efficiently manage the ever-changing needs of patients with
heart failure. The Quartet LV lead design allows the physician to
implant the lead in the most stable position without making
trade-offs in electrical performance; this has also been
demonstrated to reduce the likelihood of costly and invasive lead
revision through a second intervention procedure. St. Jude Medical
launched the company’s proprietary, first-to-market MultiPoint
Pacing technology in Europe in 2014.
The St. Jude Medical MORE CRT MPP clinical study is designed to
demonstrate the benefits of the St. Jude Medical MultiPoint Pacing
technology in improving patient response to CRT therapy.
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, 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 April 2, 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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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorKristi Warner, 651-756-2085Media
Relationskwarner@sjm.com
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