ST. PAUL, Minn.–(BUSINESS
WIRE)–St. Jude Medical, Inc., a global medical device company,
today announced it has received U.S. Food and Drug Administration (FDA)
approval of its Unify Quadra® cardiac resynchronization therapy
defibrillator (CRT-D) and Quartet® Left Ventricular Quadripolar Pacing Lead.
The company will begin shipping the products to its sales force to begin
providing to customers immediately.
As the industrys first quadripolar pacing system, the Unify
Quadra CRT-D and Quartet lead offer physicians the ability to effectively and
efficiently manage the ever-changing needs of patients with heart failure. The
system integrates multiple pacing configurations and TailoredTherapy™ features
that enable physicians to optimize the system at implant and follow-up, as well
as better manage common pacing complications without having to surgically
reposition the lead. The system is also approved for remote patient management
utilizing the Merlin.net® Patient Care Network.
The Quartet lead – used as part of the Unify Quadra system –
features four electrodes spaced over 4.7 centimeters, enabling up to 10 pacing
configurations. Multiple pacing configurations allow the physician to implant
the lead in the most stable position without making trade-offs in electrical
performance. This includes pacing closer to the base of the left ventricle,
which recent studies associate with better patient outcomes and which may be
more difficult with traditional bipolar leads. The quadripolar pacing
electrodes also provide physicians more options to optimize CRT performance,
such as pacing around scar tissue in the heart and avoiding the most common
pacing complications. The many benefits conferred from the Quartet leads
unconventional pacing have been demonstrated by implanters around the world and
reported in a number of published studies.
Common pacing complications that can occur in patients
implanted with a CRT system include high pacing thresholds and unintentional
phrenic nerve or diaphragmatic stimulation. Patients with high pacing
thresholds require significantly higher energy to pace the heart; this may reduce
the device’s battery life requiring patients to have more surgeries to replace
devices or cause pacing to be ineffective. Phrenic nerve and diaphragmatic
stimulation occur when the electrical output from a device inadvertently
activates the diaphragm muscle (either directly or via the phrenic nerve),
causing patients to hiccup with the delivery of the pacing stimuli. In
particular, phrenic nerve and diaphragmatic stimulation may be body-position
sensitive and not evident at the time of the implantation procedure, while the
patient is lying on their back. Both high pacing thresholds and phrenic nerve
or diaphragmatic stimulation are often due to the location of the pacing lead
electrode and with limited pacing options, may require that the lead be repositioned
surgically or CRT be disabled.
“The Unify Quadra system allows me to deliver effective CRT
therapy by programming different lead configurations rather than surgically
repositioning the lead itself,” said Dr. Charles Gornick, of the
Minneapolis Heart Institute at Abbott Northwestern Hospital,
a premier cardiovascular facility and the flagship center of the Allina
healthcare system in Minneapolis.
“This new technology makes it possible to further tailor CRT therapy by being
able to select different pacing vectors and adds to my potential options for
treating patients who do not respond to CRT therapy.”
The Quartet pacing lead is built on the proven QuickFlex® µ
lead platform, featuring Optim® insulation. Optim is designed to combine the
biostability and flexibility of high-performance silicone rubber with the
strength, tear resistance and abrasion resistance of polyurethane, to provide
increased durability. The leads “S-curve” fixation mechanism
delivers exceptional stability.
“In addition to not needing to compromise between lead
stability and electrical performance when placing the lead, the Quartet lead
demonstrates excellent handling characteristics that make the implant procedure
more efficient,” said Dr. Gery Tomassoni, of Lexington Cardiology at Central Baptist
Hospital in Lexington, Ky.
“This new system is designed to manage the dynamic
challenges of heart failure,” said Eric S. Fain, M.D., president of the St.
Jude Medical Cardiac Rhythm Management Division. “Based on the clinical
experiences and publications to date, this innovative CRT system has the
potential to redefine the standard of care in resynchronization therapy for
heart failure patients around the world.”
Cardiac resynchronization therapy, which can be delivered by
an implantable cardioverter defibrillator (ICD), resynchronizes the beating of
the heart’s lower chambers (ventricles), which often beat out of sync in heart
failure patients. 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.
Approximately 23 million people worldwide are afflicted with congestive heart
failure (CHF), and 2 million new cases of CHF are diagnosed each year
For more information visit SJMquadripolar.com.
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
Posted by Sean Fenske, Editor-in-Chief, MDT