480 Biomedical, Inc., based in Watertown, Massachusetts, announced two weeks ago they have received $1 million dollars in Phase II funding from the National Heart, Lung, and Blood Institute (NHLBI) to continue working on the development of a bioresorbable, self-expanding scaffold to treat Pediatric Pulmonary Artery Stenosis (PAS).
PAS is a condition which affects approximately 8 in every 10,000 infants born annually. It is a congenital defect which causes a narrowing of the pulmonary artery or one of the pulmonary artery branches. The narrowing causes a reduction in blood flow to the lungs and can result in poor oxygenation and compromised pulmonary vessel development. To compensate for the decreased blood flow, pressure in the right ventricle increases and can result in damage to the heart muscle. Symptoms such as shortness of breath, fatigue, elevated heart rate, rapid or heavy breathing and swelling in the feet, ankles, face, and/or abdomen may present in children with an artery narrowing 50% or greater.
PAS can be treated with surgery, transcatheter procedures such as balloon dilation and stenting. Balloon dilation is a procedure where a balloon is inserted into the stenotic artery and slowly inflated to expand the blood vessel. The narrowing is improved in the majority of patients with 15-20% needed additional treatment overtime. Stents can also be used in combination with balloon dilation in an attempt to maintain the vessel widening and prevent restenosis. Children treated with permanent metal stents often require re-intervention because of the challenge associated with their growing blood vessels.
480 Biomedical’s pediatric scaffold prototype is delivered minimally invasively via a small catheter and has demonstrated similar strength to currently available metal stents. The scaffold resorbs within approximately a one year period.
According to Maria Palasis, Ph.D., 480 Biomedical’s Executive Vice President and Chief Technology Officer:
Tackling this complex problem successfully will have an important impact on the clinical approach to treating PAS, and potentially other pediatric cardiac and pulmonary conditions. Our team is applying extensive knowledge and expertise from the development of our Stanza™ scaffold technology for peripheral vascular disease to transform care and improve outcomes for these young patients.