Amplatzer Piccolo (occluder)

2022: Survival rate of children with congenital heart disease when using new ocluder exceeds 95 %

In early September 2022, Abbott submitted updated data on the treatment of premature babies with heart disease, showing that 95.5% of patients were alive after three years. The company's follow-up data on the use of the Amplatzer Piccolo Occluder device shows that the self-expanding mesh device provides positive long-term results, giving Abbott further evidence to position the product as an alternative to medical treatment or surgical ligation.

The Amplatzer Piccolo Occluder device received Food and Drug Administration (FDA) approval in 2019, and the first publication of clinical trial data in 2020 noted a rate of 95.5% implantation success rate.

Amplatzer Piccolo Occluder

The open arterial duct (OAP) is a permanent opening between two large blood vessels extending from the heart. A long-term open arterial duct of large diameter, more than 5 mm, the cause of the development of one of the most formidable complications - pulmonary hypertension. The method of closing the open arterial duct is determined by the surgeon after the diagnostic examination. The disease makes normal breathing difficult for infants and occurs in 50% of premature babies and in more than 80% of severely premature babies whose birth weight does not exceed 2.2 kg. Prior to the development of Amplatzer Piccolo Occluder, physicians either performed medical treatment to give the defect time to heal or performed surgery. Transcatheter closure was reserved for larger infants.

In a statement, the director of the Guerin Family Family Congenital Heart Disease Program at Cedars-Sinai Medical Center, Evan Zahn, spoke of the fact that many patients with this disease need urgent treatment to survive, but do not respond to medical treatment and are at high risk of surgery.

The 95.5% implantation success rate obtained from Abbott suggests that Amplatzer Piccolo Occluder may be the best option for September 2022 for some patients, but the company previously did not have data on long-term patient outcomes. In addition to data related to the procedure, Abbott management reported a 2% rate of serious adverse events. No patient was affected by device-related events one year or more after implantation.

The Amplatzer Piccolo Occluder device, smaller than a pea, is inserted through an incision in the leg and guided through blood vessels to the heart. Upon reaching the heart, the device is released to seal the defect and thereby ensure normal blood flow.^[1]

2019: Entering the European market

In mid-September 2019, Abbott launched two devices to help children with congenital heart disease on the European market. One of them is the Masters HP, the world's smallest mechanical heart valve (15mm), designed to be implanted in a mitral or aortic position to mimic a child's healthy heart valve.

The second is the Amplatzer Piccolo occluder. It is the first and only device for minimally invasive transcatheter treatment of premature infants with open arterial duct threatening the life of a small patient.

Occluder Amplatzer Piccolo - a device to help children with congenital heart defects

The open arterial duct is one of the most common congenital heart defects that occur in premature babies. It is a message between two blood vessels coming from the heart. This channel is present in a normally developing fetus and allows oxygen-rich blood to circulate throughout the body, but must close shortly after birth. In some cases, primarily in premature babies, OAP cannot spontaneously close, making it difficult for the newborn's heart and lungs to function normally. OAP accounts for up to 10% of all congenital heart defects.

The Amplatzer Piccolo occluder is a wire mesh device that runs through the femoral vein to the heart and occludes the OAP. The developers claim that it can be used even in the smallest premature babies weighing only 1 kg, because the size of Amplatzer Piccolo is even smaller than a pea. The entry of this device into the market gives hope to premature and newborn babies who need corrective treatment for the open arterial duct, but have a high risk of complications in the event of invasive heart surgery.^[2]

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