ADVANCED MATERIALS & PROCESSES | MARCH 2025 35 using traditional balloon-dilation techniques. In this case, a self-expanding Nitinol frame is necessary because a balloon-mounted frame would interfere with the design of the central restriction. While Starlight’s two devices can be used to treat several CHDs separately, when used together, they can provide a fully percutaneous first-stage treatment for HLHS, a condition where the left ventricle is malformed and unable to adequately pump oxygenated blood to the body. This is one of the most morbid CHDs, and moving a highly risky surgical procedure on a newborn to a minimally invasive approach can provide major benefits to the patient and their families. FUTURE WORK FOR NITINOL Despite the significant enablers of Nitinol, several technological challenges remain in using Nitinol for pediatric applications, including: (1) limited ability to accommodate patient growth, (2) challenges in providing sufficient radial force while maintaining low profile and structural integrity, and (3) poor radiopacity of small Nitinol implants, requiring additional radiopaque markers that increase device complexity. Continued investment and research in this field are crucial to advance our understanding of cardiovascular development and intervention strategies while reducing the emotional and financial burden on families affected by CHD. ~SMST For more information: Maximilien E. Launey, senior technical fellow, G. Rau Inc., 5617 Scotts Valley Dr., Ste. 100, Scotts Valley, CA 95066, 831.244.6112, maximilien. launey@g-rau.com, www.g-rau.com. References 1. J.I. Hoffman and S. Kaplan, The Incidence of Congenital Heart Disease, J Am Coll Cardiol, 39(12), p 1890-900, 2002. 2. Congenital Heart Defects, www.cdc.gov/heart-defects/ data/index.html. Accessed 2.12.25. 3. M. Oster, et al., Temporal Trends in Survival for Infants with Critical Congenital Heart Defects, Pediatrics, 131(5), p e1502-1508, 2013. 4. https://www.fda.gov/medical-devices/products-andmedical-procedures/pediatric-medical-devices. 5. Amplatzer Vascular Plug 4 Instructions for Use (IFU). 6. B. Tang, K. Olson, and M. Juravic, A Tried-and-True Innovation Process Applied to Pediatric Congenital Heart Disease, Congenital Cardiology Today, 20(11), p 2-6, 2022. 5 FEATURE Fig. 3 — Starlight’s flow restrictor, an ePTFE-covered Nitinol device is designed to prevent over-circulation to the lungs in babies with certain pulmonary-systemic communicating circulations. Courtesy of Starlight Cardiovascular. Simplify Your Search for Vendors Find the right solutions for your business. Search for products, research companies, connect with suppliers, and make confident purchasing decisions all in one place. To appear in the listings, visit AMPdirectory.com/addyourcompany
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