FDA Approves Abbott & #039;s Device for Treating Premies with an Opening in Their Hearts

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...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news