Healthcare company Abbott (NYSE:ABT) revealed on Monday that it has passed US Food and Drug Administration (FDA) approval for the Amplatzer Piccolo Occluder for the treatment of one of the most common congenital heart defects occurring in premature babies, the patent ductus arteriosus (PDA).

PDA is a potentially life-threatening opening between two blood vessels leading from the heart. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs.

The company added that the Amplatzer Piccolo Occluder is the world's first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA.

According to the company, Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.

In addition, the company's Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart and is designed to allow the physician to insert it through the aortic or pulmonary artery.

Under the ADO II AS trial, the company evaluated the Amplatzer Piccolo Occluder and enrolled 50 patients with a PDA who were older than three days at eight centres across the US. The safety and efficacy of the device is supported by additional experience with the device under a continued access protocol involving 150 more patients.