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Structural Interventions

Amplatzer Piccolo™ Occluder

The only U.S. approved device specifically designed and indicated for Patent Ductus Arteriosus (PDA) closure in premature infants, 700g and up.

AMPLATZER PICCOLO OCCLUDER

Amplatzer Piccolo Occluder delivers PDA closure, occludes small ducts with minimal protrusion

Advancing a proven platform for predictable results.

  • Extremely low-profile delivery—4 F catheter facilitates delivery in small vasculatures
  • Self-expanding device designed for closure of a PDA with length longer than 3mm and diameter smaller than 4mm
  • Tightly woven, single-layer mesh design to minimize residual shunt after placement
  • Flexible delivery cable optimizes deployment and allows for representative preview of device orientation prior to release
  • Predictable Placement—Disc size and shape designed for predictable positioning in the duct

Little Tony was the first premature baby to receive the Amplatzer Piccolo Occluder. In Tony’s mother’s words, “we saw a difference right away, in a matter of hours.”

This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

PDA OVERVIEW

A Patent Ductus Arteriosus (PDA) can cause left-to-right shunting associated with bronchopulmonary dysplasia, pulmonary hypertension, necrotizing enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, and renal impairment.1

OBSERVATION


Doctor monitors the baby's heart to evaluate whether the open blood vessel is closing properly.

MEDICATION
THERAPY

Premature infants can take an intravenous medication (Indomethacin, Acetaminophen, or Ibuprofen) that may help close PDA.

TRANSCATHETER
CLOSURE

The Amplatzer Piccolo Occluder is precisely placed in the duct to ensure effective closure.

SURGICAL
LIGATION

Surgeon binds the ductus with a simple ligature during open heart surgery.

Early PDA closure can lead to rapid improvement in respiratory status and faster weaning off ventilator.

General PDA closure leads to proven benefits:

  • Faster weaning off mechanical ventilator
  • Oxygen supplementation
  • Improved weight gain
  • Faster decline in RSS
  • Potential avoidance of PHT

Transcatheter closure with the Amplatzer Piccolo Occluder can provide more definitive closure than medication and is less invasive than surgery.

  • Medication therapy has limited effectiveness (60-80%) and can have potential adverse effects in infants with PDA.7
  • Surgical ligation is more invasive than the occluder implanting procedure and may lead to significant procedural complications.8

ON DEMAND WEBINARS

Watch a series of recorded webinars that focus on infant PDA closure from subject matter experts to stay up-to-date on the latest recommendations, clinical data and best practices.

VIEW All Webinars

WHAT IS THE PICCOLO OCCLUDER?

 The Piccolo Occluder is the only U.S. approved device specifically designed and indicated for PDA closure in premature infants. Only Piccolo:

Has been developed for babies as small as 700g
and ≥ 3 days old

Has the most clinical data, proving excellent outcomes

Offers the widest range of sizes, enabling treatment of all duct types and sizes

Is compatible with infant size, offering a low profile device and delivery system

Amplatzer Piccolo™ Occluder implanting procedure

Implanting Procedure

The Amplatzer Piccolo Occluder implanting procedure is a minimally invasive transcatheter procedure. A small incision is made in the groin for the delivery catheter to advance through the ductus. Once the proper position is located, the occluder is deployed firmly into the ductus. The occluder’s size and shape is specifically designed to fit in the ductus of a premature infant to provide safe and effective PDA closure.

INTERVENTIONAL DEVICE EXEMPTION AND PICCOLO CLINICAL TRIAL RESULTS

Learn more

STUDY DEMONSTRATING
CASE FOR EARLY DEVICE INTERVENTION

Learn more



AMPLATZER PICCOLO OCCLUDER NEONATOLOGY BROCHURE

DOWNLOAD NOW

MAT-2210292 v4.0 | Item approved for U.S. use only.

References

* Click to view reference

  1. Sathanandam SK, Gutfinger D, O’Brien L, et al. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams. Catheter Cardiovasc Interv. 2020;1-11
  2. Gillam-Krakauer et al NeoReviews 19, No. 7 (2018): e394-e402. Chaudhary, N., et al J Neonatal Biol 5, No. 238 (2016): 2167-0897
  3. Nady, M. E., D.E. Amrousy, N. Salah and A. Zoair. “Transcatheter Versus Surgical Closure of Patent Ducturs Ateriosus in Pediatric Patients: A Systematic Review With-Meta Analysis.” SMJ Pediatr Surg 3, no. 4 (2017): 1054
  4. Zahn, Evan M., Daniel Peck, Alistair Phillips, Phillip Nevin, Kaylan Basaker, Charles Simmons, Marion E. McRae, Tracy Early. and Ruchira Gard.“Transcatheter closure of patent ductus arteriosus in extremely newborns: early results and midterm Follow-up.” JACC: Cardiovascular Interventions 9, no. 23(2016): 2429-2437
  5. Van Overmeire, Bart, Koen Smets, Dominiek Lecoutere, Hilde Van de Broek, Joost Weyler, Katya De Groote, and Jean-Paul Langhendries. “A comparison of ibuprofen and indomethacin for closure of patent ductus arteriosus.” New England Journal of Medicine 343, no. 10 (2000): 674-681
  6. Baruteau AE, et al 2014 Transcatheter closure of patent ductus aertiosus: past, present, future. Arch Cardiovasc Dis. 2014 Feb;107(2):122-32
  7. Ashrafi, Amir H., and Victor Y. Levy. “Management Strategies for the preemie ductus.” Current opinion in cardiology 32, no. 1 (2019): 41-45
  8. Van Overmeire et al. New England Journal of Medicine 343, No. 10 (2000): 674-681. Hamrick, Shannon EG et al. Pediatrics 125, No. 5 (2010): 1020-1030. Ashrafi, Amir H. et al Current opinion in cardiology 34, No. 1 (2019) 41-45
Important Safety Information
  • AMPLATZER PICCOLO™ OCCLUDER

  • Rx Only

    AMPLATZER PICCOLO™ OCCLUDER

    INDICATIONS AND USAGE

    The Amplatzer Piccolo™ 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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