Company Profile
An overview of Autus Valve Technologies, a medical device company developing innovative solutions for pediatric congenital heart disease.
Description
Founded
Leadership
Location
Founders & Team
The experienced leadership team driving the development of the Autus Valve. Click on a card to see experience.
Device Technology
A visual and technical overview of the Autus Valve, its core features, and supporting intellectual property.
Funding Analysis
Capitalization history detailing grant awards and equity financing from public sources.
Funding by Type
Competitive Landscape
How the Autus Valve's "grow-with-the-child" technology compares against market-leading, fixed-size transcatheter pulmonary valves (TPVs).
Interactive Device Snapshot
Select a feature to compare all devices at a glance.
Autus Valve
Design & Material
Surgically implanted, fully synthetic bileaflet valve inspired by venous-valve geometry.
Indications / Anatomy
Pediatric pulmonary valve replacement. Currently in an FDA-approved pivotal study.
Access Profile
Initial surgical implant. Later expansions are catheter-based, avoiding large venous access.
Growth Accommodation
Yes. Core design principle. Can be expanded post-implant to match somatic growth.
Evidence Base / Stage
Early clinical stage. Successful 11-subject Early Feasibility Study. Now in pivotal study.
Medtronic Melody™ TPV
Design & Material
Balloon-expandable TPV from a bovine jugular vein valve sewn into a platinum-iridium stent.
Indications / Anatomy
Dysfunctional RVOT conduits or existing bioprosthetic valves (≥16 mm). Not for native RVOT.
Access Profile
Requires 22 Fr venous access for its delivery system.
Growth Accommodation
No. The device has a fixed frame size.
Evidence Base / Stage
Extensive post-market data from over 18,000 patients globally. Known risks: stent fracture, endocarditis.
Medtronic Harmony™ TPV
Design & Material
Self-expanding TPV from porcine pericardial leaflets in a nitinol frame with anti-mineralization treatment.
Indications / Anatomy
Severe pulmonary regurgitation in a native or surgically-repaired RVOT.
Access Profile
Requires ~25 Fr venous access for its delivery catheter.
Growth Accommodation
No. The device has a fixed frame size.
Evidence Base / Stage
FDA approved in 2021. Growing data shows favorable performance, no endocarditis in one-year trial cohorts.
Edwards SAPIEN 3 w/ Alterra
Design & Material
Two-part system: A self-expanding nitinol 'Alterra' prestent creates a landing zone for the SAPIEN 3 valve.
Indications / Anatomy
Severe pulmonary regurgitation in patients with a wide range of RVOT morphologies.
Access Profile
Requires 16 Fr eSheath, the smallest access profile of the current TPVs.
Growth Accommodation
No. The device has a fixed frame size.
Evidence Base / Stage
FDA approved in 2021 for severe PR. Clinical data is growing from pivotal trials and early commercial use.
The primary distinction is the target population. Autus Valve is aimed at younger, smaller children needing surgical replacement who are poor candidates for the large delivery systems of most TPVs.
The TPVs compete for larger children, adolescents, and adults. Here, access profile is a key differentiator. The Edwards SAPIEN 3 with Alterra has the smallest profile at 16 Fr, potentially expanding access to smaller patients compared to Melody™ (22 Fr) and Harmony™ (~25 Fr). Autus's paradigm—one surgery followed by catheter-based expansions—aims to avoid this TPV sizing issue altogether in early childhood.
VC Investment Insights
Qualitative due diligence summary assessing the management team, market opportunity, and technology.