ABBOTT PARK, Ill., Jan. 14, 2019
/PRNewswire/ -- Abbott (NYSE: ABT) today announced the
U.S. Food and Drug Administration (FDA) approved the Amplatzer
Piccolo™ Occluder, the world's first medical device that can be
implanted in the tiniest babies (weighing as little as two pounds)
using a minimally invasive procedure to treat patent ductus
arteriosus, or PDA. The Amplatzer Piccolo, a device even smaller
than a small pea, now offers hope to premature infants and newborns
who need corrective treatment, and who may be non-responsive to
medical management and high risk to undergo corrective surgery.
One of the most common congenital heart defects occurring in
premature babies, PDA is a potentially life-threatening opening
between two blood vessels leading from the heart. This channel,
which is present in normally developing fetuses, is important prior
to birth to allow oxygen-rich blood from the mother to circulate
throughout the fetus' body. For most infants, the pathway, or duct,
seals itself shortly after birth. In some cases, primarily in
babies born prematurely, the PDA fails to spontaneously close,
which can make it difficult for babies to breathe normally due to
increased blood flow to the lungs. PDA accounts for up to 10
percent of all congenital heart disease.4
Approximately 60,000 premature babies in the U.S. are born each
year with a very low birth weight5, and nearly 12,000
(one out of five) of these have a hemodynamically significant PDA
–a PDA that is large and causes symptoms – which will require
urgent treatment for the baby to survive.6,7
"This approval is a potentially life-saving advance for the very
smallest premature infants that will help us treat these delicate
babies who might otherwise not be able to survive," said
Evan Zahn, M.D., director of the
Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute,
and principal investigator for the study that led to FDA
approval.
The Amplatzer Piccolo Occluder is a self-expanding, wire mesh
device that is inserted through a small incision in the leg and
guided through vessels to the heart, where it is placed to seal the
opening in the heart. It is designed to allow the physician to
insert it through the aortic or pulmonary artery, as well as to
retrieve and redeploy the device for optimal placement. Because the
device is deployed in a minimally invasive procedure, many of the
premature babies who are critically ill in the neonatal intensive
care unit are able to be weaned from artificial respirator support
soon after the procedure.
Born at 27 weeks, twin babies Irie and
Judah Felkner of Columbus,
Ohio, were both fighting for their lives in the neonatal
intensive care unit when an echocardiogram revealed Irie had a PDA
that required immediate treatment.
"The doctor thought Abbott's Amplatzer Piccolo device was the
best solution for Irie, and after learning more about the procedure
we decided to move forward," said Crissa Felkner, Irie's mother.
"You have to live it to fully appreciate what that device did for
our daughter. Three days after the procedure, she was making great
progress and is now a normal toddler with no limitations. The
Abbott device was truly lifesaving for our daughter."
The Felkner twins were treated as part of the U.S. pivotal
trial, ADO II AS, which helped to support the FDA approval of the
device. The trial evaluated the Amplatzer Piccolo Occluder and
enrolled 50 patients with a PDA who were older than three days at
eight centers across the U.S. The safety and efficacy of the device
is further supported by additional experience with the device under
a continued access protocol involving 150 more patients.
"Piccolo is a critical advancement in the standard of care for
the most vulnerable of premature babies who may not be able to
undergo surgery to repair their hearts," said Michael Dale,
vice president for Abbott's structural heart business. "Our mission
is to develop life-changing technology to help people live better
lives through improved health. This approval is another important
step toward achieving our mission for the patients and physicians
we serve."
The Amplatzer Piccolo device builds on more than 20 years of
clinical success for Abbott's family of Amplatzer Occluder
therapies, including the Amplatzer™ Duct Occluder II product,
already approved for use in the U.S., Europe and countries around the world to treat
PDA in larger size pediatric patients.
Abbott is committed to developing minimally invasive life-saving
pediatric devices that have an immediate impact with long-term
benefits, reduce the risks of life-threatening complications and
allow physicians to confidently treat the youngest and tiniest
patients. The FDA approval of the Amplatzer Piccolo device follows
last year's approval of the world's smallest rotatable mechanical
heart valve. The Masters HP 15mm pediatric mechanical heart valve
provided surgeons with a much-needed option for treating
vulnerable, high-risk pediatric patients with congenital heart
defects and no other approved options.
For U.S. Important Safety Information about the Amplatzer
Piccolo Occluder, visit
https://www.structuralheartsolutions.com/us/piccolo-ISI.
About Abbott
At Abbott, we're committed to helping people live their best
possible life through the power of health. For more than 125 years,
we've brought new products and technologies to the world -- in
nutrition, diagnostics, medical devices and branded generic
pharmaceuticals -- that create more possibilities for more people
at all stages of life. Today, 99,000 of us are working to help
people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
1 National Vital Statistics Reports: Births: Final
Data for 2016. Final Vol 67; Number 1; January 31, 2018.
2 Tashiro, Jun, Bo
Wang, Juan E. Sola,
Anthony R. Hogan, Holly L. Neville, and Eduardo A. Perez. "Patent ductus arteriosus
ligation in premature infants in the
United States." journal of surgical research 190, no. 2
(2014): 613-622.
3 Bonamy, Anna-Karin
Edstedt, Anna Gudmundsdottir,
Rolf F. Maier, Liis Toome, Jennifer
Zeitlin, Mercedes Bonet,
Alan Fenton et al. "Patent ductus
arteriosus treatment in very preterm infants: a european
population-based cohort study (EPICE) on variation and outcomes."
Neonatology 111, no. 4 (2017): 367-375.
4 Schneider, D. J., & Moore, J. W. (2006). Patent
ductus arteriosus. Circulation, 114(17), 1873-18.
5 National Vital Statistics Reports: Births: Final
Data for 2016. Final Vol 67; Number 1; January 31, 2018.
6 Tashiro, Jun, Bo
Wang, Juan E. Sola,
Anthony R. Hogan, Holly L. Neville, and Eduardo A. Perez. "Patent ductus arteriosus
ligation in premature infants in the
United States." journal of surgical research 190, no. 2
(2014): 613-622.
7 Bonamy, Anna-Karin
Edstedt, Anna Gudmundsdottir,
Rolf F. Maier, Liis Toome, Jennifer
Zeitlin, Mercedes Bonet,
Alan Fenton et al. "Patent ductus
arteriosus treatment in very preterm infants: a european
population-based cohort study (EPICE) on variation and outcomes."
Neonatology 111, no. 4 (2017): 367-375.
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SOURCE Abbott