Abbott has secured approval from the US Food and Drug Administration (FDA) for its Amplatzer Piccolo occluder to treat premature babies and newborns with an opening in their hearts.
Amplatzer Piccolo is claimed to be the world’s first medical device, which can be implanted in the tiniest babies with weight of less than two pounds through using a minimally invasive procedure to treat patent ductus arteriosus (PDA).
Amplatzer Piccolo, which is smaller than a small pea, is used to treat premature infants and newborns, who are non-responsive to medical management and high risk to undergo corrective surgery.
PDA is one of the most common congenital heart defects and potential life-threatening opening between two blood vessels that leads from the heart.
The channel is present in normally developing fetuses, and is crucial prior to birth to allow oxygen-rich blood from the mother to circulate across the fetus’ body.
Amplatzer Piccolo occluder is a self-expanding and wire mesh device, which is inserted via small incision in the leg and guided through vessels to the heart to seal opening in the heart.
Physician will insert the occluder through the aortic or pulmonary artery, and can retrieve and redeploy the device for optimal placement.
Most of the premature babies with critical condition in the neonatal intensive care unit can be weaned from artificial respirator support after the procedure, as the device is deployed through minimally invasive procedure.
The Ado II AS trial assessed the Amplatzer Piccolo occluder in 50 patients with a PDA who were older than three days at eight centers across the US
Abbott also noted that the safety and efficacy of the device is further supported by additional experience with the device under a continued access protocol involving 150 more patients.
Amplatzer duct occluder II product is already approved to treat PDA in larger size pediatric patients in the US, Europe and other countries across the world.
Abbott’s structural heart business vice president Michael Dale said: “Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts.
“Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve.”