PolyVascular, leading the effort to improve children’s lives with a novel polymeric transcatheter valve (PTV) for children, announced that it was awarded a $2 million Small Business Innovation Research (SBIR) Phase II grant earlier this year to bring its polymeric stent-mounted valve (SMV) to clinical trials within the next two years in an effort to address pediatric congenital heart disease (CHD), which affects over 1 million patients around the world.
As part of the next stage of growth for the company, PolyVascular named Will Clifton, M.D., as Chief Operating Officer (COO) to oversee the completion of the grant as Principal Investigator and to manage the operations and R&D for the company.
PolyVascular’s SMV is composed of polymer leaflets mounted within a metal stent that can be delivered via a minimally invasive transcatheter procedure, avoiding the risks of surgery, with potential for improved durability and function. Congenital heart disease remains the most common category of birth defect and a leading cause of childhood death in the developed world. Dysfunctional pulmonary valves (PV) are a common abnormality, and frequently require surgical intervention and replacement. Valve replacement through open heart surgery carries substantial risk and discomfort for pediatric 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 or biological tissue from animals), but are in short supply and have a tendency to not last very long, leading to repeat surgeries.