Pediatric Resorbable, Self-expanding Scaffold
480 Biomedical is developing a pediatric scaffold to address a significant unmet clinical need for children with cardiovascular defects. The scaffold technology will provide a combination of strength and flexibility to support lumen patency and apposition during vessel growth. While resorption facilitates re-intervention, if necessary, with no permanent implant left behind.
Approximately 2,500 children are born each year with pulmonary artery stenosis, with another ~7500 affected by a range of additional cardiology conditions including aortic coarctation, pulmonary vein stenosis, hypoplastic left heart syndrome, and William’s syndrome. Children requiring treatment early in life for congenital cardiovascular defects have limited effective minimally invasive treatment options because subsequent vessel growth is not compatible with permanent implants (e.g. metal stents) and one or more interventions are needed by nearly all patients to maintain apposition between the device and the growing vessel wall. Currently the best treatment option is surgery which is highly invasive and successful only 60% of the time. Balloon angioplasty, while attractive due to absence of a permanent implant, has poor acute success rates (31%).