ST. PAUL, Minn. St. Jude Medical, Inc., a
global medical device company, today announced U.S.
Food and Drug Administration(FDA) approval of the first-to-market MultiPoint™ Pacing technology featured on the
Quadra Assura MP™ cardiac
resynchronization therapy defibrillator (CRT-D), the Quadra Allure MP™ CRT-pacemaker
(CRT-P) and two new quadripolar Quartet™ LV leads. MultiPoint Pacing
technology enables a revolutionary approach and provides additional options,
which may benefit CRT patients who are not responsive to other pacing
alternatives. This approval is an important first step in the rollout of
MultiPoint Pacing technology, and availability to U.S. physicians is expected
in the first half of this year.
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. CRT
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.
Despite the improvements seen
with quadripolar CRT technology, non-responders to therapy remain a significant
issue. Also, non-responders to CRT are not able to be identified at the time of
implant and individual patient response can be unpredictable.
Previous studies have shown that activating more
ventricular tissue faster may enhance heart muscle performance. MultiPoint
Pacing technology allows physicians the opportunity to capture more left
ventricular tissue quickly by delivering pacing pulses to multiple left
ventricle locations rather than the traditional single pulse for each
heartbeat. Using the Quartet™ LV lead with
its four uniquely spaced electrodes, physicians now have the capability to
program two pulses from a single lead and tailor them to the specific needs of
each patient.
“Having the ability to truly
individualize cardiac resynchronization therapy is a significant step forward
in the clinical approach to treating some of our most complex heart failure
patients,” said Dr. Gery Tomassoni, director of electrophysiology at Baptist
Health Lexington in Lexington,
Kentucky. “MultiPoint Pacing technology provides a new set of tools
that can be non-invasively programmed in an attempt to improve CRT response,
thus opening up an important new treatment option for many patients who may
need it.”
St. Jude Medical also
announced FDA approval of additional
quadripolar pacing Quartet LV leads, which can be used with MultiPoint Pacing
technology, as well as the programmer-based Auto VectSelect Quartet™ Test.
The two new leads are designed based on the company’s first-to-market,
clinically proven Quadripolar LV lead technology and include additional electrode
spacing options on two new S-curve shaped lead designs. The expanded family of
Quartet LV leads offers more options to effectively meet the needs of patients
with larger as well as smaller cardiac anatomies. Physicians can quickly
customize therapy using the new automated Auto VectSelect Quartet Test, which
is designed to offer comprehensive testing results so appropriate therapy
options can be easily and efficiently programmed for each patient in a
streamlined workflow.
“Continuing our quadripolar
leadership, MultiPoint Pacing represents our commitment to invest and innovate
in state of the art heart failure treatment options,” saidPhilip Ebeling,
vice president and chief technology officer for St.
Jude Medical. “These additions to our comprehensive CRT portfolio are
examples of St. Jude Medical’s focus on providing physicians with technologies
that result in effective patient outcomes and transform the treatment of some
of the world’s most expensive epidemic diseases.”
St. Jude Medical developed
and launched the industry’s first quadripolar pacing system in the U.S. 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 has been demonstrated to reduce the likelihood of costly and invasive
lead revision through a second intervention procedure. MultiPoint Pacing
technology shifts the treatment options from a single point of pacing to
multiple quadripolar pacing offerings that provide physicians more advanced
options to optimize CRT performance.
Source: St.
Jude Medical, Inc.
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