Project Grant R44HL183952

The National Heart, Lung, and Blood Institute awarded Pediastent LLC $1.472 million on August 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to conduct a first-in-baby clinical study of the CARDIAZN bioresorbable stent, a zinc-alloy device designed to treat pulmonary artery stenosis and coarctation of the aorta in small children.

The CARDIAZN stent maintains peak radial strength for approximately six months post-implantation to provide structural support to diseased and dilated vessels, then undergoes cell detachment to allow normal vessel growth while continuing to biodegrade without requiring further intervention. The device addresses a gap identified by pediatric cardiologists in treatment options for congenital vascular narrowing; existing approaches—open-heart surgery or metal stent placement—carry high morbidity rates, require multiple subsequent interventions under anesthesia and radiation, and are unavailable for small children. The addressable U.S. market spans approximately seven thousand units for both indications combined. Prior GLP porcine studies demonstrated vascular support through six months followed by growth and full vessel patency through thirty months, with histopathology and micro-CT analysis confirming complete stent encapsulation in the vessel wall.

Performance occurs in Chagrin Falls, Ohio through July 31, 2029.