Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children

Congenital heart disease (CHD) remains the most common category of birth defect and a leading cause of childhood death in the developed world. Of the constellation of structural defects that comprise CHD, dysfunctional pulmonary valves (PV) are the most frequent valve replacement in children, and in severe CHD, require surgical intervention and replacement. Valve replacement through open heart surgery carries substantial risk and discomfort for patients, and represents a major financial and emotional burden for families. The most commonly used valves for pulmonary valve replacement in young children are biologically-derived (e.g. human cadaveric valves). Such replacements are in short supply, and have other inherent disadvantages, such as poor long-term durability, and propensity to induce a host immune response. The combination of these factors leads to a cycle of repeat surgical interventions, using valves that are scarcely available and destined for rapid failure. PolyVascular has sought to address these issues by developing a polymeric stent-mounted valve (SMV), comprised of polymer-derived leaflets mounted within a metal stent, that can be delivered via minimally invasive transcatheter techniques, avoiding the burden of repeat surgeries, with potential for improved durability and function. The present proposal describes a first in human clinical trial to study PolyVascular’s novel Transcatheter Pulmonary Valve (TPV) designed for children. Aim 1 prepares PolyVascular for Early Feasibility Study by requesting a clinical pre-submission meeting with FDA, manufacturing PolyVascular TPV Systems, and setting up three clinical sites. Aim 2 describes the study design and execution of the study, enrolling up to 15 patients with a 6 month follow up primary safety and efficacy endpoint and publication of these results. Successful completion of these Aims will demonstrate safety and feasibility, paving the way for a pivotal trial and regulatory approval.