Autus Size-Adjustable Pulmonary Valve
Surgical pulmonary valve replacement in pediatric patients with congenital heart disease
PivotalActive
Key Facts
Indication
Surgical pulmonary valve replacement in pediatric patients with congenital heart disease
Phase
Pivotal
Status
Active
Company
About Autus Valve
Autus Valve is a private, pre-revenue medical device innovator targeting a significant unmet need in pediatric cardiology: durable, growth-accommodating pulmonary valve replacements. The company's core technology is the Autus Valve, a fully synthetic, biomimetic bileaflet valve that is surgically implanted but designed for future transcatheter balloon expansion as the patient grows, eliminating the need for multiple major surgeries. Autus Valve has initiated an FDA-approved pivotal clinical study and is actively enrolling patients, positioning it as a late-stage clinical contender in the congenital heart device market with a highly specialized product.
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