FDA Approves Abbott's Device for Treating Premies with an Opening in Their Hearts

Abbott says its Amplatzer Piccolo Occluder is the first device approved for use in the tiniest babies (weighing as little as two pounds) to treat patent ductus arteriosus, a common congenital defect.

Born at 27 weeks, twin babies Irie and Judah Felkner of Columbus, Ohio, were both fighting for their lives in the neonatal intensive care unit when an echocardiogram revealed Irie had a patent ductus arteriosus (PDA) that required immediate treatment.

"The doctor thought Abbott's Amplatzer Piccolo device was the best solution for Irie, and after learning more about the procedure we decided to move forward," said Crissa Felkner, Irie's mother. "You have to live it to fully appreciate what that device did for our daughter. Three days after the procedure, she was making great progress and is now a normal toddler with no limitations. The Abbott device was truly lifesaving for our daughter."

The Amplatzer Piccolo Occluder just became the first minimally invasive, transcatheter treatment specifically approved by FDA for premature babies with a PDA. The device is smaller than a pea, Abbott said.

The Felkner twins were treated as part of the U.S. pivotal trial, ADO II AS, which helped to support the FDA approval of the device. The trial enrolled 50 patients with a PDA who were older than three days at eight U.S. centers. The safety and efficacy of the device are further supported by additional experience with the device under a continued access protocol involving 150 more patients, Abbott noted in a press release.

One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus' body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10% of all congenital heart disease, Abbott said.

"This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive," said Evan Zahn, MD, director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute, and principal investigator for the study that led to FDA approval.

The 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. It is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement. Because the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure.

Abbott said the Amplatzer Piccolo device builds on more than 20 years of clinical success for the company's family of Amplatzer Occluder therapies, including the Amplatzer Duct Occluder II product, already approved for use in the U.S., Europe, and countries around the world to treat PDA in larger size pediatric patients.

FDA approval of the Amplatzer Piccolo device follows last year's approval of the world's smallest rotatable mechanical heart valve, Abbott said. The Masters HP 15mm pediatric mechanical heart valve provided surgeons with a much-needed option for treating vulnerable, high-risk pediatric patients with congenital heart defects and no other approved options.

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