Fragile beginnings to flourishing second graders

How medical innovation, expert care, and perseverance helped premature twins overcome challenges and thrive.

For the roughly 370,000 preemies born in the U.S. each year, the first weeks of life can be filled with challenges. A key focus for their care team is helping them grow and gain weight – often while managing additional health complications. In the neonatal intensive care unit (NICU), every calorie matters, and nutrition becomes a cornerstone of care.

Crissa Felkner and her husband Matt experienced this firsthand with their twins, Irie and Judah. Born at just 27 weeks, underweight and fragile, the twins faced daily health struggles while in the NICU.

To support the twins’ nutritional needs, Crissa’s breast milk was fortified with human milk fortifier. Breast milk is best for preterm babies and neonatologists may add human milk fortifiers to breast milk. These fortifiers added protein, vitamins, and calories to help Irie and Judah grow.

As Crissa’s breast milk supply began to decrease while in the NICU, doctors also recommended she use infant formula to help meet each twin’s unique nutritional needs. Irie was fed a combination of breast milk and Similac Neosure, a specialized formula designed to support the growth and development of preterm babies post discharge. Judah was given a combination of breast milk and Similac Alimentum, a specialized hypoallergenic term infant formula made with extensively hydrolyzed protein.

“It relieved so much of my stress knowing they were both getting the nutrition they needed,” Crissa said. “It’s already such a challenging time, so having one less thing to worry about was a huge weight off my shoulders.”

While the twins were in the NICU, a new challenge arose. An echocardiogram revealed Irie had a congenital defect called a patent ductus arteriosus (PDA), an opening between two blood vessels leading from the heart that is also present in normally developing fetuses.

For most babies, that opening seals itself shortly after birth, but in premature infants like Irie, it can remain open, causing breathing difficulties. Irie’s doctor recommended a clinical trial for Abbott’s Amplatzer Piccolo™ Occluder – a minimally invasive device designed to close PDA in preemies without open-heart surgery. Thankfully, Nationwide Children’s Hospital in Columbus, Ohio – where she and Judah were cared for – was one of eight trial locations. Irie’s parents consented to the trial, and the procedure successfully closed her PDA.

Within three days of the procedure, Irie was off the ventilator and breathing on her own. After 90 days in the hospital, she and her brother were finally able to go home.

In January 2019, the FDA approved the Amplatzer Piccolo Occluder for closing a PDA in premature infants.

Thanks in large part to medical advancements and the dedication of their doctors, Irie and Judah are now thriving eight-year-olds. Now in second grade, Irie enjoys gymnastics and softball, while Judah is a baseball player and red belt in taekwondo.

Crissa and Matt credit healthcare innovations with saving their children’s lives. “If it wasn't for these medical advancements, life could be very different today,” Crissa said.

Important Safety Information

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

WARNINGS

  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Do not use the device if the sterile package is open or damaged.
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • Patients who are allergic to nickel can have an allergic reaction to this device.
  • Prepare for situations that require the removal of this device. Preparation includes access to a transcatheter snare kit and an on-site surgeon.
  • Accurate measurements of the ductus are crucial for correct occluder size selection.
  • Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable.
  • Remove embolized devices. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter.

PRECAUTIONS

  • This device should be used only by physicians who are trained in standard transcatheter techniques. Determine which patients are candidates for procedures that use this device.
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device.
  • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated.
  • The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach. However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury.
  •  The AMPLATZER PiccoloTM Occluder contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days following implant. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should seek immediate medical attention if there is suspicion of an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
  • Use in specific populations
    • Pregnancy — Minimize radiation exposure to the fetus and the mother.
    • Nursing mothers — There has been no quantitative assessment for the presence of leachables in breast milk.
  • Store in a dry place.
  • Do not use contrast power injection with delivery catheter.

MR CONDITIONAL

St. Jude Medical’s AMPLATZERTM Duct Occluder II device is manufactured of chemically etched nitinol wire, 80% platinum 20% iridium marker band and a 316L end screw.

Non-clinical testing has demonstrated that the AMPLATZERTM Duct Occluder II device is MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T).
  • Maximum spatial gradient field less than or equal to 30 T/m.
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

In non-clinical testing with body coil excitation, the AMPLATZERTM Duct Occluder II device produced a differential temperature rise of less than or equal to 3.65°C when exposed to a maximum average whole body specific absorption rate (SAR) of 2.80 W/kg for 15 minutes of scanning in a 1.5 Tesla MR system (SiemensTM MAGNETOM EspreeTM, SYNGOTM MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

MR Image quality may be compromised if the area of interest is the same or relatively close to the position of the device. Therefore, it may be necessary to optimize the MR imaging parameters for the presence of this implant.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:

  • Air embolus
  • Allergic dye reaction
  • Allergic drug reaction
  • Anesthesia reactions
  • Apnea
  • Arrhythmia
  • Bacterial endocarditis
  • Bleeding
  • Cardiac perforation
  • Cardiac tamponade
  • Chest pain
  • Device embolization
  • Device erosion
  • Death
  • 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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