IntelliStent: A minimally Invasive, Adjustable Pulmonary Flow Restrictor System for Congenital and Acquired Heart Disease

ABSTRACT HeartPoint Global’s IntelliStent is the first minimally invasive, adjustable pulmonary flow restrictor developed for pediatric and congenital heart disease (CHD) patients. Treatments to modify pulmonary flow in the pediatric and CHD populations are currently limited to open-chest pulmonary artery banding (PAB) and expensive medication regimens. Both of these treatments have severe limitations, including significant risks of morbidity and mortality, and have high rates of failure. There is a critical unmet need to develop novel treatments that are both more effective and less risky than current approaches. Previous attempts to adapt devices designed for adult cardiovascular treatments have been unsuccessful, largely due to the unique characteristics of pediatric and CHD patients. IntelliStent is currently developed in a size range suitable for patients 12 years and up, with successful pre-clinical testing completed that showed no signs of thrombosis in chronic (9.5 month) studies. Re- engineering the IntelliStent in a size range suitable for neonates and infants would represent the first minimally- invasive treatment specifically developed for children. This proposal aims to prepare IntelliStent for first-in-human testing for sizes in patients from birth. Our specific aims are: (1) Downsize the IntelliStent to be suitable for patients from birth, including preclinical testing; (2) Complete biocompatibility testing as required for regulatory submission; and, (3) Optimize manufacturing processes for clinical and commercial production. Successful completion of this proposal would bring to market a novel treatment for pulmonary flow modification and represent a transformative step in the treatment of pediatric patients with congenital and acquired heart disease.