Autus Valve Technologies Inc is structured around development of a medical device designed to prevent the complications of valve prosthesis-patient mismatch. The firm's developed device offers the capability for diameter expansion pre-and post-implantation, via minimally invasive transcatheter balloon dilation, enabling healthcare institutions to improve the overall quality of patient's life and long-term survival, and (potentially) dramatically to reduce incurred health care costs. Bavkground to the projet includes a single-arm, multi-center study to evaluate safety and preliminary effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 2 to 10 years (± 6 months) requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implant, at hospital discharge, 30 days, 6 and 12 months, and annually through 5 years. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.
