Piccolo Occluder Honored for Innovation

Chicago Innovation Awards honors revolutionary occluder for helping preemie babies with congenital heart defects.

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Strategy and Strength | Oct. 30, 2019

For the 10th time in its 18 years, the Chicago Innovation Awards have honored Abbott among the leaders in creating technology that’s changing the world.

This time around, our Amplatzer Piccolo™ Occluder has been recognized.

As you might guess from it's name, our Piccolo Occluder is small. It's smaller than a pea. But for the tiniest patients who need it, it makes a huge difference in their lives.

How?

By closing the connection between two blood vessels leading from the heart of preemie babies called a patent ductus arterios (PDA), the harmful back flow of blood into the premature lungs is blocked and the babies can then breathe more easily and get off the ventilator that is keeping them alive. It is delivered to the heart via a catheter, enabling doctors to treat PDA without subjecting babies to open chest surgery.

About 12,000 premature babies born in the U.S. each year suffer from an enlarged PDA. About 36,000 kids in Europe are born with the condition. With recent governmental approvals, Piccolo is available to help more children around the world.

"Piccolo is among the best examples of Abbott’s promise to help people live their fullest lives — in this case, young babies and children for whom this treatment is nothing short of miraculous," said Michael Dale, vice president of Abbott’s structural heart division.

Irie Faulkner was one of those children.

When she and her twin brother Judah were born prematurely at 27 weeks, their parents knew the first few months wouldn't be easy.

While the twins were fighting for their lives in the neonatal intensive care unit (NICU), hooked up on ventilators, an echocardiogram showed Irie’s PDA in her heart had grown too large.

A Piccolo Occluder successfully closed her PDA. Within three days, Irie was able to breathe on her own, taken off the ventilator. Now she’s home, growing and thriving.

"You have to live it to fully appreciate what that device did for our daughter," said Matt, Irie's dad.

The Chicago Innovation Awards see it, as did nearly 1,500 business and civic leaders and supporters of innovation in attendance at Chicago’s Harris Theater on Monday.

"450 organizations were nominated for this year's awards," said Luke Tanen, Executive Director of the Chicago Innovation Awards. "As a group, these nominees generated the creation of 1001 patents. The 25 winners represent the best from this very impressive group."

This isn't the first time Abbott has been honored by the Chicago Innovation Awards, including:

IMPORTANT SAFETY INFORMATION

AMPLATZER PICCOLO™ 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.

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