NHLBI Funds Development of a Bioresorbable Scaffold for Pediatric Pulmonary Artery Stenosis
July 9, 2014—480 Biomedical, Inc. announced that it has been awarded phase II funding from the National Heart, Lung, and Blood Institute (NHLBI) to continue the development of a bioresorbable, self-expanding scaffold to treat pediatric pulmonary artery stenosis.
According to the company, the device aims to address the challenges in treating cardiovascular stenosis in children with growing blood vessels. The scaffold’s design has the strength of a balloon-expandable metal stent to keep vessels open for an extended period before safely resorbing. The scaffold can also be delivered through a small catheter, which is essential for treating a pediatric population. The funding from the NHLBI will be used to further refine the design of the product and conduct preclinical testing.
The company noted that metal stents, which are currently used in these procedures, are not well suited for pediatric patients because they become restrictive as the patient grows. Pediatric patients who are treated with metal stents often require reintervention or surgical removal of the stent to address arterial obstruction and to reestablish blood flow.
In the 480 Biomedical press release, Robert J. Lederman, MD, Senior Investigator and Chief of Cardiovascular Intervention for the NHLBI’s Division of Intramural Research, commented, “There has not been a significant advance in this area in decades. 480 Biomedical is the right team to develop a product that will help solve the critical challenge facing pediatric cardiologists in treating pulmonary artery stenosis. We are excited about the progress made to date and the overall important effort underway to improve care for the smallest, most vulnerable cardiology patients, who deserve our attention.”
480 Biomedical stated that it has successfully developed a prototype of the pediatric scaffold that demonstrates acute strength similar to a metal stent, tissue absorption over the course of approximately 1 year, and minimally invasive delivery of the scaffold through a small, flexible catheter. Under the provisions of the NHLBI contract, 480 Biomedical is responsible for the overall development of the pediatric scaffold, and the NHLBI will undertake clinical study of the product.
480 Biomedical first developed the Stanza scaffold technology for peripheral vascular disease and will use that knowledge to develop the device for pediatric pulmonary artery stenosis. The Stanza scaffold technology combines biocompatible materials with engineering to provide the optimal balance of radial force, flexibility, and bioresorbability. This scaffold, which can also be used for controlled drug delivery for several months, supports the lumen while healing occurs, resorbing in about a year. The strength of the scaffold, followed by its resorption, provides the benefits of scaffolding while avoiding the potential downsides of a permanent implant, including irritation, fracture, and difficulty of retreatment, stated the company.