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PATIENT INFORMATION

Exploring Amplatzer Piccolo™ for premature infant PDA closure

This can be a challenging time for parents of newborn children who require PDA closure. There's a simple device that may help.

THE PICCOLO DEVICE SAVED
BABY IRIE’S LIFE BY CLOSING A PDA

“The Abbott Piccolo device helped our daughter get off the ventilator within 3 days. It was a miracle to us.” – Irie’s Dad

Born prematurely at 27 weeks, Irie Felkner had a patent ductus arterious (PDA) and fought for her life in the neonatal intensive care unit (NICU).

Hear the story of one of the first newborns to receive Abbott’s life-changing Amplatzer Piccolo Occluder device - the world’s first and only PDA closure device able to seal an opening in her tiny heart.

WHAT IS A PDA IN INFANTS?

A patent ductus arteriosus (PDA) is an opening that abnormally remains open in the heart after birth, between the aorta and the pulmonary artery.

You're not alone. Every year, nearly 12,000 premature babies in the U.S., like Irie, are born with an open PDA, requiring urgent treatment to survive.

1
In the baby's heart, the ductus arteriosus remains open while in the womb so a mother’s oxygenated blood can bypass the lungs and flow directly into her child’s heart.
2
For most babies, their ductus arteriosus closes shortly after birth.
3
But in some cases, this hole fails to close and is called a patent ductus arteriosus or PDA. With a significant PDA, oxygen-rich blood can pass through the opening and mix with oxygen-poor blood, which causes the heart to overwork, can inhibit growth and become life-threatening.
4
To safely close a PDA, Amplatzer Piccolo™ can be inserted through a vein in the leg, up to the ductus, to seal the opening in the heart.
Ductus Arteriosus
Heart Model 2
Normal Heart
Patent Ductus Arteriosus (PDA)
Heart Model 2
Amplatzer Piccolo™


WHAT IS PICCOLO AND HOW DOES IT TREAT A PDA?

The Amplatzer Piccolo™ Occluder is the only minimally invasive PDA closure device that is FDA approved for premature infants.

The device can be safely implanted to help seal the opening in the heart (close the PDA) without open heart surgery and your baby's heart tissue will eventually grow over the device, sealing the hole. Early PDA closure can lead to improved outcomes for your child.

Speak to a Physician Near Me

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AMPLATZER PICCOLO™ PARENT BROCHURE

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FREQUENTLY ASKED QUESTIONS ABOUT PDA

  • What are some symptoms of a PDA?

    Medium to large PDAs may cause feeding intolerance, NEC, fatigue and poor growth eventually leading to heart failure. All sizes of PDAs may increase a patient’s risk for a bacterial infection.

  • How is PDA treated?

    There are multiple treatment options for a PDA, and you should talk with your child’s doctor to learn about the best treatment option for them. Medications are usually given as a first treatment option, which may help close the PDA or treat symptoms of the PDA. Occasionally a minimally invasive procedure or even surgery may be needed.

  • Which PDA treatment option is right for my child?

    Every infant is unique. Your child’s doctor is your best resource for learning about the PDA treatment options available to your child and the best course for their condition. Talk to your child’s doctor and follow his or her advice for their care. Remember, a PDA can result in life threatening symptoms and increased health risk. With proper care, however, it can generally be managed with medication or PDA closure.

  • What is involved in the procedure?

    Closing a PDA with the Amplatzer Piccolo™ Occluder is a minimally invasive procedure that does not require open heart surgery.

    The procedure usually takes 1-2 hours and is performed by a physician with specialized training.

  • What happens after the procedure?

    Additional monitoring will continue in the NICU to address the other medical needs of your child, however the closing of the hole in your child's heart may have a positive effect on some of the other medical issues your child may be experiencing. After your child is discharged from the NICU, your doctor will schedule follow-up appointments to ensure your child's recovery is continuing to progress.

  • How long will it take my child to recover?

    Your child will remain in NICU as doctors address any other medical issues with your child, however recovery from device closure can be almost immediate. Every infant recovers differently, and your doctor can share the individualized plan for your child.

  • Is the device painful, or will my child be able to feel the device?

    Once the procedure is over, your child will not feel the device, or pain because of the device.

MAT-2210291 v2.0 | Item approved for U.S. use only.

References
  1. Dice DE. and Bhatia J. Patent Ductus Arteriosus: An Overview. J Pediatr Pharmacol Ther .2007;12(3), 138-146
  2. Semberova J, et al. Spontaneous Closure of Patent Ductus Arteriosus in Infants
  3. Krasuki, R.A. (2006) Patent ductus arteriosus closure. Journal of Interventional Cardiology, 19 (5 Suppl), S60-66
  4. Schneider, D.J., & Moore, J.W. (2006). Patent ductus arteriosus. Circulation, 114(17), 1873-1882. 3. Dice JE, Bhatia J. Patent ductus arteriosus: an overview. J Pediatr Pharmacol Ther 2007;12(3):138–46.
  5. Data on File, 302350-001_G Amplatzer Duct Occluder CER.
  6. Cincinnati Children’s. Congenital Patent Ductus Arteriosus. www.cincinnatichildrens.org/health/heart-encyclopedia/anomalies/pda.htm. Accessed February 2, 2016.
Important Safety Information
  • AMPLATZER PICCOLO™ OCCLUDER

  • AMPLATZER PICCOLOTM OCCLUDER
    INDICATIONS AND USAGE

    The AMPLATZER PiccoloTM Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

    CONTRAINDICATIONS

    Weight < 700 grams at time of the procedure; Age < 3 days at time of procedure; Coarctation of the aorta; Left pulmonary artery stenosis; Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension; Intracardiac thrombus that may interfere with the implant procedure; Active infection requiring treatment at the time of implant; Patients with a PDA length smaller than 3 mm; Patients with a PDA diameter that is greater than 4 mm at the narrowest portion

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, Fever, Headache/migraine, Hemolysis, Hematoma, Hypertension, Hypotension, Infection, Myocardial infarction, Palpitations, Partial obstruction of aorta, Partial obstruction of pulmonary artery, Pericardial effusion, Pericarditis, Peripheral embolism, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation

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