ST. PAUL, Minn., St.
Jude Medical, Inc., a global
medical device company, recently received U.S.
Food and Drug Administration(FDA) approval of the company’s proprietary, first-to-market MultiPoint™ Pacing technology and today announced the U.S. launch and first U.S. implants
of the Quadra Assura MP™ cardiac
resynchronization therapy defibrillator (CRT-D). MultiPoint Pacing technology
is a revolutionary approach designed for CRT patients who are not responsive to
other pacing options.
The first implant took place at Saint Francis Hospital in Hartford,
Conn. Speaking about
the opportunity, Dr.Neal Lippman, electrophysiologist with Arrhythmia Consultants of
Connecticut at Saint
Francis said, “We are
now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our
patients whose heart failure condition is difficult to manage. It is important
for us to have this option to individualize patient care and help improve
response to therapy.”
Despite the improvements in
patient outcomes seen with quadripolar CRT technology, a small, but important
group of patients do not respond optimally to the therapy. Importantly, these
“non-responders” to CRT cannot be identified at the time of implant and how
effective the therapy will be in addressing an individual patient’s heart
failure symptoms can be unpredictable. MultiPoint Pacing technology offers
physicians a new set of tools that allow for individualized patient therapy
with the goal of optimizing their response to CRT.
“St. Jude Medical developed and
established a new standard of care for CRT with quadripolar pacing. We are
excited to bring the next-generation MultiPoint Pacing technology to market,
giving physicians additional options to improve patient response,” said Dr. Mark D. Carlson, vice
president of global clinical affairs and chief medical officer at St.
Jude Medical.
Cardiac resynchronization therapy
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 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.
According to the American Heart
Association, CRT can improve the heart’s efficiency at pumping
blood to the body and can lessen symptoms of heart failure, including shortness
of breath. However, even with effective placement of the leads around the
heart, therapy can be unpredictable and ineffective for some patients.
MultiPoint Pacing technology allows physicians to program the device to
stimulate more left-ventricular tissue at one time by pacing at multiple
locations in the heart, more similar to the natural electrical behavior of the
heart. Over 60 abstracts and publications demonstrate that this increases the
number of patients who benefit from this type of therapy (CRT).
A recent study demonstrated that the St. Jude Medical
MultiPoint Pacing technology may be particularly beneficial in patients not
responding to traditional bi-ventricular pacing therapy, which accounts for
approximately one third of the total population of patients receiving CRT. In
this study, MultiPoint Pacing technology realized a 90 percent responder rate
for patients with MultiPoint Pacing at one year compared to traditional methods
of CRT. Several ongoing studies continue to build the body of evidence and
examine the benefits patients receive from MultiPoint Pacing including the St.
Jude MedicalMORE CRT MPP clinical
study, designed to demonstrate the benefits of the St. Jude Medical
MultiPoint Pacing technology in improving patient response to CRT therapy. Data
from the MultiPoint Pacing Investigational Device Exemption (IDE) study will be
presented during a late-breaking clinical trial
session during
the Heart Rhythm Society’s (HRS) 37th annual scientific sessions, May 4 – 7 in San
Francisco.
Approximately 23 million people
worldwide are afflicted with congestive heart failure and 2 million new cases
are diagnosed worldwide each year. Studies have shown that CRT can improve the quality of life for
many patients with heart failure, a progressive condition in which the heart
weakens and loses its ability to pump an adequate supply of blood. The CRT
technology resynchronizes the lower chambers (ventricles) of the heart by
sending uniquely programmed electrical impulses to stimulate each ventricle to
beat in sync for optimal cardiac performance.
St. Jude Medical developed
and launched the industry’s first quadripolar pacing system in the
United States in 2011
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 also reduces the likelihood of costly and invasive lead
revision through a second intervention procedure. Adding MultiPoint Pacing
technology and additional lead sizes to the quadripolar offerings provides
physicians more advanced options to optimize CRT performance, such as improving
hemodynamics, resynchronization and reverse remodeling of the heart.
Source: St. Jude Medical
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