World-Changing Ideas for Health

Fast Company has honored us as its 2020 World Changing Company of the Year.

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Strategy and Strength | Apr. 28, 2020

Fast Company has named Abbott as the 2020 World Changing Company of the Year in honor of the company's innovative efforts to improve lives.

According to Fast Company, honoring Abbott "recognizes a range of devices and projects to improve global health – from a new implant to keep babies' hearts healthy, to fighting malaria, to advancing the careers of underrepresented people in STEM."

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World Changing Ideas is one of Fast Company’s major annual awards programs that focuses on ideas and innovation that can lead to societal benefit.

For Abbott, the award showcases the impact of technology and programs that have helped people around the world. One example: Abbott's Amplatzer Piccolo Occluder, a device to treat premature babies and newborns with an opening in their heart was named a finalist for Health and Wellness. This technology is helping people like Irie Felkner.

Born premature at 27 weeks with her twin brother Judah, an echocardiogram showed an opening in Irie’s heart had grown too large. A life-threatening 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 — had failed to close, making it difficult for her to breathe normally with the increased flow of blood to the lungs. With our Amplatzer Piccolo Occluder, Irie’s doctors were able to successfully close her PDA. She was able to breathe on her own within three days and taken off her ventilator. She’s now home, thriving.

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“There seems no better time to recognize organizations that are using their ingenuity, resources, and, in some cases, their scale to tackle society’s biggest problems,” said Stephanie Mehta, editor in chief of Fast Company.

IMPORTANT SAFETY INFORMATION

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 

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 Piccolo 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