FDA Approves Device to Treat Heart Defect in Premature Infants

The US Food and Drug Administration (FDA) has approved the Amplatzer Piccolo Occluder, a medical device that can be implanted via catheter to treat patent ductus arteriosus (PDA) in very low birth weight babies.

The device is smaller than a pea, allowing it to be implanted in babies weighing as little as 2 pounds who have a life-threatening opening in their heart. These patients may not respond to medical management and, due to their size, may be high-risk for corrective surgery.

"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.

Patent ductus arteriosus occurs when a normal opening between blood vessels in a fetus’ heart fails to close after birth. The Amplatzer Piccolo is a wire mesh device that may be inserted via catheter through the aortic or pulmonary artery.

The FDA’s approval was supported by data from the pivotal trial ADO II AS, which evaluated the Amplatzer Piccolo Occluder. The trial included 50 patients with patent ductus arteriosus who were older than 3 days and weighed at least 700 g (1 lb, 8.6 oz). An additional 150 patients were treated with the device under a continued access protocol.

"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," said Michael Dale, vice president for Abbott's structural heart business. "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."