enVVeno Medical — LATAM FIH Foundation → First-Ever FDA IDE for a Non-Surgical Replacement Venous Valve (2026)

enVVeno Medical is developing bioprosthetic replacement venous valves for severe deep chronic venous insufficiency (CVI). bioaccess® supported enVVeno's early first-in-human clinical work in Latin America. On April 29, 2026, enVVeno's next-generation, non-surgical enVVe® System received the first-ever FDA IDE approval for a U.S. pivotal study — the TAVVE® study — in severe deep CVI. The IDE authorizes the U.S. pivotal STUDY; it is not a device clearance or approval. All enVVeno devices remain investigational.

Study facts

• Sponsor / company: enVVeno Medical
• Indication / area: Vascular Surgery
• Country: Colombia
• Study type: First-in-Human (FIH)

Key metrics

• LATAM FIH: Colombia
• 2026 Milestone: First-ever FDA IDE (non-surgical)
• U.S. Pivotal: TAVVE® study
• Indication: Severe deep CVI

The challenge

Chronic venous insufficiency affects over 150 million people worldwide, and severe deep CVI has no approved replacement-valve option. enVVeno needed disciplined first-in-human clinical experience in Latin America to inform its long-term U.S. regulatory strategy while preserving capital.

bioaccess® solution

bioaccess® identified vascular surgery centers in Colombia with expertise in venous disease, supported ethics and regulatory approval, and managed clinical operations, surgical logistics, and follow-up data collection under ISO 14155-aligned protocols. That LATAM foundation contributed to the clinical evidence base that enVVeno has built as it advanced its non-surgical enVVe® System toward the U.S. pivotal pathway.

Results

• bioaccess® supported enVVeno's early first-in-human clinical work in Latin America (Colombia)
• Non-surgical enVVe® System received first-ever FDA IDE approval for a U.S. pivotal study (TAVVE®) on April 29, 2026
• IDE authorizes the U.S. pivotal STUDY in severe deep chronic venous insufficiency — not a device clearance or approval
• Clinical operations delivered under ISO 14155-aligned protocols in LATAM
• LATAM execution structured for cost efficiency versus a comparable U.S. program

Frequently asked

What did bioaccess® do for enVVeno Medical?

bioaccess® identified vascular surgery centers in Colombia with expertise in venous disease, supported ethics and regulatory approval, and managed clinical operations, surgical logistics, and follow-up data collection under ISO 14155-aligned protocols.

Where was the enVVeno Medical First-in-Human (FIH) study run?

The enVVeno Medical First-in-Human (FIH) study was executed in Colombia by bioaccess® in the vascular surgery area.

What was the outcome of the enVVeno Medical study?

Reported outcomes for enVVeno Medical's device: bioaccess® supported enVVeno's early first-in-human clinical work in Latin America (Colombia); Non-surgical enVVe® System received first-ever FDA IDE approval for a U.S. pivotal study (TAVVE®) on April 29, 2026; IDE authorizes the U.S. pivotal STUDY in severe deep chronic venous insufficiency — not a device clearance or approval.

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