Autus Valve Technologies, Inc.
Medical device company developing a size-adjustable synthetic pulmonary valve for pediatric patients. The organization has pursued preclinical bench and animal studies, completed an early feasibility study including a first-in-human implant, and is conducting an FDA-approved pivotal clinical study in the U.S. The technology emphasizes a biomimetic bileaflet geometry, customizable implant diameter, and balloon-expandable transcatheter compatibility to accommodate patient growth.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Size-adjustable synthetic pulmonary valve (pediatric)
A fully synthetic pulmonary valve replacement engineered to be size-adjustable, with a bileaflet biomimetic geometry and the ability to be balloon-expanded via transcatheter approach to accommodate patient growth.
Size-adjustable synthetic pulmonary valve (pediatric)
A fully synthetic pulmonary valve replacement engineered to be size-adjustable, with a bileaflet biomimetic geometry and the ability to be balloon-expanded via transcatheter approach to accommodate patient growth.
Expertise Areas
- Pediatric heart valve design
- Transcatheter device development
- Preclinical testing and large-animal studies
- Clinical trial management for medical devices
Key Technologies
- Size-adjustable valve architecture
- Biomimetic bileaflet valve geometry
- Balloon-expandable transcatheter delivery
- Bench testing and large-animal models
News & Updates
Multiple conference presentations describing implant technique, outcomes, and innovations in pediatric structural heart interventions.
Article/presentation hosted by Columbia University / NewYork-Presbyterian describing the technology and clinical approach.
Coverage summarizing the potential clinical impact of the size-adjustable valve.
Peer-reviewed publication describing the adaptable valve design.
Received Breakthrough Device designation from the U.S. Food and Drug Administration for the novel pulmonary valve device.
Successfully performed first-in-human implant of the size-adjustable pulmonary valve.
Multiple conference presentations describing implant technique, outcomes, and innovations in pediatric structural heart interventions.
Article/presentation hosted by Columbia University / NewYork-Presbyterian describing the technology and clinical approach.
Coverage summarizing the potential clinical impact of the size-adjustable valve.
Peer-reviewed publication describing the adaptable valve design.
Received Breakthrough Device designation from the U.S. Food and Drug Administration for the novel pulmonary valve device.
Successfully performed first-in-human implant of the size-adjustable pulmonary valve.