ADVANCED MATERIALS & PROCESSES | MARCH 2025 33 NITINOL IN PEDIATRICS: HELPING BABIES AND CHILDREN WITH CONGENITAL HEART DISEASES Pediatric devices made with superelastic Nitinol offer flexibility and minimally invasive surgical alternatives for delicate and tortuous vessel anatomy, though further development is needed to accommodate device growth as children develop. Maximilien E. Launey* G. Rau Inc., Scotts Valley, California Congenital heart diseases (CHDs) represent the most common birth defect globally, affecting approximately 1.3 million babies worldwide[1,2]. There are at least 18 distinct types of recognized CHDs, with many additional anatomic variations, ranging from simple conditions that may resolve spontaneously to complex anomalies requiring immediate medical intervention. The most common types include ventricular septal defects, which account for about 20-30% of all CHDs, followed by atrial septal defects, patent ductus arteriosus (PDA), and tetralogy of Fallot (TOF). Approximately one in four babies with a heart defect has a critical congenital heart disease (CCHD), generally requiring surgery or other procedures in their first year of life, often within the first few days or weeks after birth[3]. These conditions include hypoplastic left heart syndrome (HLHS), transposition of the great arteries, truncus arteriosus, total anomalous pulmonary venous return, tricuspid atresia, pulmonary atresia, and severe forms of TOF. The hallmark of CCHDs is their potential to cause severe hypoxemia, acidosis, shock, and death if left untreated. The FDA is committed to assuring pediatric patients have access to safe and effective medical products. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use. Through federal laws, pediatric research, and child-focused initiatives, the FDA is committed to supporting the development and availability of safe and effective pediatric medical devices[4]. CCHD TREATMENTS Surgical intervention remains the cornerstone of CCHD treatment, with procedures varying from complete anatomical repairs to staged palliative surgeries. For instance, HLHS typically requires a three-stage surgical approach beginning with the Norwood procedure in the neonatal period, followed by the Glenn shunt at 4-6 months, and finally, the Fontan completion around age 2-4 years. Recovery from these surgeries often requires multiple days in the hospital and several weeks at home. These procedures leave visible scarring and may need to be conducted multiple times as the child grows. Hybrid approaches combining surgical and catheter- based interventions have emerged as innovative treatment options for select patients, potentially reducing procedural risks and improving outcomes. The development of transcatheter occluder devices has revolutionized the treatment of many congenital cardiac defects. These devices can be broadly categorized into septal occluders and vascular occlusion devices. Modern septal occluders utilize double-disk designs constructed from Nitinol wire mesh designed to allow delivery through microcatheters as small as 0.038 in.[5] The most widely used devices include the Abbott Amplatzer and the Gore Helex septal occluders. These devices feature self-centering mechanisms and varying waist lengths to accommodate different anatomical variants. Vascular plugs and coils are designed for closure of PDA, collateral vessels, and other vascular communications. However, the vast majority of interventional devices that are used to treat pediatric patients are used off-label and were not meant for these anatomies or conditions. Pediatric stenting represents another crucial advancement in treating various congenital and acquired vascular conditions in children. Unlike adult interventions, pediatric stenting poses unique challenges due to children’s growing bodies and smaller vessel sizes. The field emerged in the early 1990s as an alternative to surgical intervention for conditions including pulmonary artery stenosis, coarctation of the aorta, and venous obstructions. While stenting offers the advantage of being minimally invasive, reducing recovery time and surgical complications in young patients, it requires careful consideration of several factors. The most critical challenge is accommodating future growth— the stent must be able to expand as the child grows, either through balloon dilation or through the use of bioabsorbable materials. MINIMA STENT Renata Medical is a medical device company focused on developing transformative congenital heart devices for neonates, infants, and young children around the world. The company was founded by Dustin Armer and Eason Abbott FEATURE 3 *Member of ASM International
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