St. Jude Medical Launches U.S. Study of the Country’s Smallest Pediatric Mechanical Heart Valve
February 10 2015 - 09:00AM
Business Wire
The HALO Trial represents a new opportunity for surgeons seeking
a valve replacement for pediatric patients with no alternative
approved treatment options
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced the launch of the HALO U.S. IDE Trial. The
trial will evaluate the safety and efficacy of the St. Jude Medical
Masters HPTM Series 15mm mechanical heart valve, the smallest
pediatric mechanical heart valve in the world. The HALO Trial will
enroll pediatric patients in need of mitral valve replacement who
cannot be implanted with the current range of approved valves
without additional risks and who have no alternative approved
treatment options.
Image of the St. Jude Medical Masters HP
Series 15mm mechanical heart valve pictured in comparison to an
adult-sized mechanical heart valve. (Photo: Business Wire)
In the U.S. alone, more than 35,000 babies are born each year
with congenital heart defects, some of which will impact valve
function to the point they’ll require surgical valve replacement.
For many of these patients, mechanical heart valves can effectively
mimic natural heart valves, opening and closing with each heart
beat and permitting blood flow into the heart. While there are
several replacement valves of varying size available for older
patients, there are no prosthetic heart valves under 16mm in tissue
diameter approved for standard use in newborns, infants and
toddlers.
With limited availability of valves that can suitably match the
anatomy of children under the age of five, some surgeons are forced
to implant larger valves in their smallest patients, which may lead
to suboptimal placement that can disrupt hemodynamics, damage to
surrounding tissue and an elevated risk of side effects such as
poor blood pressure and potential heart blockage.
“There’s a profound need within the medical community for a
mechanical heart valve dedicated to our tiniest patients who can’t
safely be implanted with the current range of valve sizes,” said
Dr. Kirk R. Kanter, professor of surgery at the Emory University
School of Medicine and cardiothoracic surgeon and surgical director
of the Heart Transplant Program at Children's Healthcare of
Atlanta. “This small valve represents a big step forward in helping
cardiovascular surgeons provide our patients the optimal level of
care.”
In 2007, the U.S. Congress passed the Pediatric Medical Device
Safety and Improvement Act to prompt development of medical devices
designed and engineered specifically for the pediatric patient
population. With its legacy of innovation in the field of pediatric
cardiology, St. Jude Medical was uniquely positioned to meet the
challenge of designing a mechanical heart valve that could provide
very young patients a chance of survival until they can be
implanted with a larger, permanent valve implant they will carry
with them the rest of their life.
The launch of the HALO IDE stems from a new approach to the
design, evaluation and regulatory approval of pediatric heart
valves that emerged from an FDA led workshop in 2010 organized in
response to the pressing need to develop products for this patient
population. In a speech held in October 2014 the St. Jude Medical
pediatric heart valve was cited by FDA Commissioner Margaret A.
Hamburg, M.D., as an example of what collaboration can achieve when
industry, FDA staff, clinicians and academics come together to
support pediatric medical device development.
The HALO Trial will enroll patients at up to 40 sites
nationwide. Data collected during the HALO Trial across all trial
sites will be used to support FDA approval of the Masters Series
15mm mechanical heart valve, which is currently available only
under “emergency or compassionate use” protocols.
“The Masters Series 15mm mechanical heart valve was developed
based on feedback we received from physicians and the FDA’s Office
of Pediatric Therapeutics, who have expressed the need for a more
suitable mechanical heart valve to offer pediatric patients for
which there are simply no other options,” said Dr. Mark Carlson,
vice president of global clinical affairs and chief medical officer
at St. Jude Medical. “As a market leader in pediatric cardiology
solutions, St. Jude Medical has the capability to develop devices
that fill critical needs, and we will continue to look for more
opportunities to create solutions for some of the biggest
challenges facing pediatric surgeons and cardiologists today.”
St. Jude Medical is a market leader in designing and developing
electrophysiology and interventional cardiology solutions for
pediatric patients worldwide. The company currently offers low
voltage and high voltage pacemakers, ablation catheters and
occluders to treat congenital heart defects for the pediatric
population. In addition, St. Jude Medical is the most experienced
mechanical valve company in the world, with more than 2 million
valves implanted to date.
About St. Jude MedicalSt. Jude Medical is a global
medical device manufacturer 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 has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more
information, please visit sjm.com or follow us on Twitter
@SJM_Media.
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http://www.businesswire.com/multimedia/home/20150210005764/en/
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorJustin Paquette, 651-756-6293Media
Relationsjpaquette@sjm.com
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