- Results reinforce that Amplatzer Piccolo™ Occluder is safe and
effective for closing an opening in the heart known as a "patent
ductus arteriosus" (PDA) in newborns
- Study found low adverse event rates following a Piccolo
procedure, showing additional benefit of the device that can help
babies avoid riskier surgery
- A PDA is present in approximately 1 in 2,000
births1
ABBOTT
PARK, Ill., Sept. 8,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced three-year data showing the positive impact of the
Amplatzer Piccolo™ Occluder on treating babies (some weighing as
little as two pounds) with a potentially life-threatening hole in
the heart known as a patent ductus arteriosus (PDA). The Amplatzer
Piccolo device is smaller than a pea and is the world's first and
only minimally invasive, transcatheter treatment approved to close
a PDA in premature infants with this common congenital heart
defect.
The latest data were presented at the Pediatric and Congenital
Interventional Cardiovascular Society Symposium, held in
Chicago from September 7-10, 2022.
A PDA is an opening between two blood vessels in an infant's
heart that fails to close as it should following birth. Before a
baby is born, this channel allows blood to bypass the
not-yet-functioning lungs because the fetus gets oxygen-rich blood
from the mother. If the hole remains open after birth, it
changes the flow pattern so additional blood is directed to the
lungs, making it difficult for babies to breathe normally. Prior to
the development of Abbott's minimally invasive Piccolo closure
device, physicians and families often had to decide between placing
a baby on respiratory support to see if the defect sealed on its
own or conducting a risky surgical procedure to close the PDA.
Three-Year Results from the Amplatzer Piccolo Study
The ADO II AS trial showed the safety and effectiveness of the
Amplatzer Piccolo device in closing PDAs in premature babies, with
data through three years showing:
- High survival rate (95.5%), with no procedure-related
deaths
- High implant success rate (95.5%) and complete PDA closure in
nearly all patients
- Low device-related serious adverse event rate (2%) with no late
(>1 year) device-related events
The data confirm that the Amplatzer Piccolo Occluder can offer
high success rates in terms of PDA closure while offering low
adverse event rates. The minimally invasive approach to delivery of
the device also reduces the need to subject many of the tiniest
patients to riskier surgical procedures.
"The Amplatzer Piccolo Occluder is a lifesaving device for
premature infants with PDAs, many of whom require urgent treatment
to survive but aren't responding to medical management and are at
high risk for surgery," said Evan
Zahn, M.D., director of the Guerin Family Congenital Heart
Program in the Smidt Heart Institute and Department of Pediatrics
at Cedars-Sinai Medical Center, and principal investigator of the
ADO II AS trial. "The data from this study reinforce Piccolo's
ability to safely and effectively treat this life-threatening heart
problem for our tiniest patients."
About the Amplatzer Piccolo Occluder
The Amplatzer Piccolo 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's placed to seal the PDA. As a
minimally invasive procedure, many of the premature babies who are
critically ill in the neonatal intensive care unit can be weaned
from artificial respirator support soon after the device is
implanted. The U.S. Food and Drug Administration approved the
Amplatzer Piccolo Occluder in 2019.
Almost seven years ago, "Little Tony" Daly of Las Vegas was the first to receive the
Amplatzer Piccolo as an investigational device. Born at 26 weeks
and weighing about two pounds, Tony had a PDA that caused fatigue
and intestinal issues.
"We trusted the doctor's recommendation to close Tony's PDA with
Abbott's Amplatzer Piccolo Occluder, and we're thankful we did – we
consider the device to be our son's lifesaver," said Anthony Daly, Tony's father. "There was an
immediate improvement in Tony's health just days after the
procedure and today he's a thriving first grader who's active in
soccer, tennis and hockey."
"There are thousands of stories of infants in need that inspire
us to continue innovating to help the youngest and most vulnerable
babies," said Michael Dale, senior
vice president of Abbott's structural heart business. "We realize
just how important our commitment to restoring health is when we
hear about pediatric patients who can begin living their best lives
thanks to devices like our Amplatzer Piccolo Occluder."
Abbott's portfolio of pediatric heart therapies also includes
the world's smallest rotatable mechanical heart valve, the Masters
HP 15mm, and the HeartMate 3 heart pump which is approved for
pediatric patients. Abbott is committed to developing lifesaving
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.
For U.S. Important Safety Information about the Amplatzer
Piccolo Occluder, visit https://abbo.tt/PiccoloISI.
For U.S. Important Safety Information about the Masters HP 15mm
valve, visit https://abbo.tt/MastersISI.
For U.S. Important Safety Information about the HeartMate 3,
visit https://cardiovascular.abbott/hm3isw.
About Abbott:
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1 Krasuki, R. A. (2006). Patent ductus arteriosus
closure. Journal of Interventional Cardiology, 19 (5 Suppl),
S60-S66.
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SOURCE Abbott